GRAPPA
Friday, November 19, 2004
Philip Mease: Could people begin to take their seats, please?
PHILIP MEASE: Good morning. Welcome to the GRAPPA meeting at EADV in Florence. My name is Philip Mease from Seattle, Washington, a rheumatologist. OK, apparently they are signaling to—
So we thank you very much, too, for coming in very early this morning. I know it is not the typical Italian mode, and I’m sure all of you went to bed quite early last night to be prepared for this.
So we have been graciously supported for this and other GRAPPA activities throughout the year.
I wanted to acknowledge the companies that have been funding us. They include Abbott,
Amgen, Biogen, Centocor, Novartis, Schering-Plough, and Wyeth, and our great appreciation for this. What you will be seeing over the course of the morning is some brief introductory comments from Dafna Gladman, myself, and Alan Menter, and included in those comments will be some of the accomplishments of GRAPPA thus far for orientation purposes. Then what we really want to do primarily is get into a discussion of the integration between rheumatologists and dermatologists and how best to do this and, in particular, working relationships between
GRAPPA and the International Psoriasis Council which Alan Menter is chairing.
Just to very quickly go through some of the accomplishments that have been achieved by
GRAPPA. We have been working through a prioritization of domains of inquiry in psoriatic arthritis and, to a certain extent, psoriasis. This was a consensus process finalized at OMERACT which Dafna will introduce you to this year. We have written and compiled more than 25 articles which will be a state-of-the-art review of psoriatic arthritis and psoriasis which will appear as a supplement to The Annals of Rheumatic Disease in approximately April or May of 2005.
Another is the existence of an Internet site where communication occurs, and we have had regular meetings at both rheumatology meetings such as ACR and EULAR as well as dermatology meetings such as AAD and EADV as well as OMERACT. We have had one conjoint meeting between dermatologists and rheumatologists that was held in New York in
2003, and we are looking forward to the possibility of a conjoint meeting either in the latter part of 2005 or 2006, and that is one of the items we will be discussing. There are a number of committees that are looking at various specific work projects having to do with outcome measure development and treatment guideline development which we will be summarizing this morning.
So with that, I am going to turn the microphone over to Dafna.
DAFNA GLADMAN
OMERACT – Process, Outcomes and Research Agenda

Hi, it’s really a pleasure to be here and see so many of you attending the meeting. We have been trying to increase our interaction collaboration with dermatology because GRAPPA stands for
“Group for research and assessment of psoriasis and psoriatic arthritis” and, of course, to do that, we need very interactive and collaborative effort to help our patients.
What I’m going to do this morning is actually describe to you the process that we have taken to arrive at some of these outcome measures. Before we get into it, I just want to highlight the problem that we have in looking at psoriatic arthritis. I am sure that you all recognize the different patterns that we see--the distal joint disease, the oligoarthritis, polyarthritis--and you can see the features that we distinguish psoriatic arthritis from rheumatoid arthritis by, the shortening of the digits which is the result of the pencil-and-cup change that we see. We see arthritis mutilans, which actually gets rid of some of the phalanges for these patients, and the back involvement, which consists clinically of the inability to bend down, which results from the syndesmophytes that can be similar to what we see in ankylosing spondylitis or can be very typical of power marginal syndesmophytes, and of course, the same changes can occur in the neck and the sacroiliitis. The other features that we have in psoriatic arthritis, in addition to the joint disease, are the dactylitis which is the inflammation of the whole finger or toe, which can be chronic as it is in this case, or very acute, where you can actually see the inflammation in the individual joints as well as the swelling of the whole digit, and the enthesitis, which we can see clinically and radiologically.
In order to address how to assess patients with psoriatic arthritis, we have been through a process which culminated in the OMERACT presentation. Just so that we are all on the same page, I thought I would just briefly review what OMERACT is. It started out as a group to assess outcome measures in rheumatoid arthritis clinical trials. In 1992, it was established as an outcome measures in rheumatology clinical trials and, more recently, they say they are just outcome measures in rheumatology. Of course, the “CT” does not quite fit, but it is still called
OMERACT. So, it was established as a group in 1992 at a meeting in Maastricht in the
Netherlands, and it was established as an informal international network of rheumatologists and individuals that study rheumatologic disorders. The process involves achieving consensus on outcome measures and, again, it is in rheumatology, and it is based on the OMERACT filter which has three concepts in it. The first one is truth which means we are looking at face, content, construct, and criteria validity. Basically, does the measure address what it was supposed to address? Does it look at what it was meant to be? And in an unbiased and relevant way. The second part is discrimination which relates to reliability and sensitivity to change; does it discriminate between situations of interest? Does a joint count vary over time? Does the PASI score vary over time? That would be the kind of thing we would be looking at. And, finally, feasibility. Can the measure be applied to different situations pragmatically, particularly because we are talking about an international scenario, so we are talking about different situations in terms of healthcare systems, in terms of language differences, in terms of cultural differences, and also in terms of financial situations. So those are the three concepts that every measure which is being studied at OMERACT needs to actually achieve.
With that in mind, how did we go through the process? Well, our process began with a Delphi exercise, which I am going to describe to you, and it occurred through a group called CASPAR which is a group that got together under the leadership of Philip Helliwell from Leeds, England,

to develop classification criteria for psoriatic arthritis. So there were 54 members of CASPAR at the time. In order to start the process, a group of us got together and reviewed the existing assessment instruments in psoriatic arthritis—and this is a paper that we published in Arthritis and Rheumatism earlier this year. That review was distributed to all the members of CASPAR and through the review, we developed a list of domains that we thought were important in looking at symptomatic improvement, disease-modifying medication, longitudinal observational cohort, as well as rehabilitation. The Delphi process allows us to rank/order those different components via questionnaire which was sent initially to 54 rheumatologists; 32 responded to the first round and those are the ones that got the second two rounds. So the questionnaire includes
100 points which are supposed to be divided amongst the 24 domains. The way you do it is you give the highest number to the domain that you think is most important. So the point allocation actually reflects the relative significance or importance of an individual domain. What you do is you send it around the first time and you get everybody’s results; you do an analysis and provide a distribution which reflects the totality of the participants. Then you send that back to all the participants. Now, you know what you’ve done; now you see what everybody else has done and you try and get consensus by—sort of—bringing everybody together. Now some people change; others do not. But at the end of the day you get something like this. And what you can see here is that each color represents round 1, 2, and 3. So the red, yellow, and green. What happened was during the three iterations of this, the spread got smaller, so there was a bit of consensus. But, as you can see from the graph, there is absolutely no significant difference in the components that were considered important. So at the end of the day, these were components that were considered important, and these were kind of left off that list. I want you to notice that skin disease is way down here.
So, in August of 2003, we had the first GRAPPA meeting in New York. At that time, in addition to our initial interaction with rheumatologists, dermatologists, members of patient groups, and members of the industry, we wanted to specifically further define these domains by a nominal group process and achieve consensus on these domains. And this is what happened: we broke out into three groups; each group had a combination of the different constituents of our meeting and you can see that now skin disease is #3. What we did is we identified domains and we divided them into measures of inflammation, patient-derived measures, and damage. And we identified some instruments already, like the ACR joint count for peripheral arthritis, or the visual analog scale, ESR and CRP, some of the patient instruments, and you will see that skin disease is to be determined, although these are some of the possibilities.
So that led us to the OMERACT workshop which took place in May of this year in Asilomar,
California. You can see the members of the steering committee which included Jerry Krueger, and Jerry actually participated in the meeting. Again, what we did is we reviewed for the participants the domains that were identified—so basically what I have just done for you today— everybody understood where we were, and then we reviewed the instruments that were used for psoriatic arthritis by Philip Mease and for psoriasis by Jerry Krueger. We then reviewed radiological assessment techniques, and we had our break-out groups. The next morning we had
Christian Antoni present a study which analyzed the instruments that were actually used in clinical trials and actually gave us some insight that I think Philip is going to share with us.
Finally, we discussed the results of the break-out groups and actually had a vote. The vote—this is the result of the break-out groups. Actually we had 12 break-out groups here and you can see

the relative importance that each of the groups put on the various things, and there is the final rank score. At the end of the day at OMERACT there is a process whereby you vote electronically. So we ended up with these domains reaching a pretty high score for the top five, and you can see that down here, between enthesitis and fatigue, there is a much larger break. On the other hand, that break made dactylitis and physician global below the cut-off. So we have continued to work on it, and decided to develop a research agenda which, again, is part of the
OMERACT process, but it is also a part of the GRAPPA process. You can see that the number of items on the agenda basically reflect the number of items that we have identified as important domains to be included in the assessments of patients with psoriatic arthritis.
I am just going to point out a couple. For example, in terms of the peripheral joint assessment in psoriatic arthritis, we recognize that the ACR joint count is an appropriate joint count. But the question is, how many joints do you count? Do you count only 68 joints, which is what we do in rheumatoid arthritis; do you include the distal interphalangeal joints of the feet, which would make it 76 joints? do you include the carpometacarpal joints which would make it 78 joints? So, this is the kind of discussion that we have been having in terms of coming down with the right instrument. Likewise, when you are looking at patient global or even physician global, an issue that arose is when you ask a patient, “Tell us on a 0 to 5 scale, how your disease affects you?”
The question is, which disease are you talking about? Are you talking about the joint disease, or are you talking about the skin disease? Does it matter? So we have a group now that is actually looking into understanding whether the skin and the joints contribute differently to the overall patient and likewise the physician global assessment and so on. In the skin disease, which is one of the reasons that we really are interested in collaboration here, is, we rheumatologists do not feel that we should be developing assessment tools for psoriasis. We feel that it is the dermatologists that should be doing that. We would like to collaborate and cooperate and interact and help in terms of the background information, the methodology, and so on, but the actual tool needs to be developed by the experts. So that is something we would really like the dermatology colleagues to actually do and share.
Some of the other things—we won’t go into detail here—but as a result of the identified research agenda, we now have a number of research committees within GRAPPA—and you can see that sometimes we have one person who has taken it on, and sometimes we have a group of people who work together who have taken it on—but we are particularly interested in the peripheral joint assessment, the global assessment, dactylitis and enthesitis, quality-of-life and participation, which is a new word for us which reflects the person’s ability to participate in life activities. Up until now, we were talking about quality-of-life and function, but you would not be able to evaluate things if a patient did not work, then what would you do with it? And even if a patient goes to work, do they actually participate in their work activities? Do they participate in their leisure activities? There are now a number of instruments that are being developed, and there is a group that is headed by Philip Mease with Will Taylor and Doug Veale who is actually going to be looking at it. One of the things that some of you—if you have looked at your e-mails—may have already looked at—there is a process that Will Taylor has actually started, similar to what I have described to you, the Delphi process that we did in psoriatic arthritis. He is now repeating it including dermatologists and rheumatologists to come up with areas—particularly he is interested in the participation area which is now mandated by the World Health Organization. So you will hear more and more about it. And then we have the spinal assessments; we have

treatment guidelines which, again, Philip will go into; immunohistology and biomarkers which is an area that is growing and needs standardization; imaging; and then, more recently, in the last
GRAPPA meeting in San Antonio, we decided that we really need to develop methodology and recording ways for economic impact.
Finally, the last thing I wanted to show you is this is a dynamic process. We had a workshop in
OMERACT 7, and we have now submitted a proposal for a module which is a little bit more extensive. This time we really want to get not just domains that we have looked at before; now we are trying to identify a core set of domains that need to be included in every clinical trial in longitudinal observational cohorts, and these are some of the key domains that we feel would be important. Again, I highlighted skin because we really need the help. Thank you very much for your attention.
Applause.
If there are any questions, please press your buttons so that you can be recorded. If there are no questions, we will move on.
PHILIP MEASE
ACR GRAPPA Meeting Summary – Outcome Measure Research Methodology, Treatment
Guidelines for PsA, Committee Structure
We will have lots of time for just general round-robin discussion shortly. Robin Shapiro, who everyone here knows, has prepared a few slides which review current membership of GRAPPA.
This is the distribution relative to whether it is in or out of North America and the total—so the total is about 155 members now—and it is more predominantly rheumatologists than dermatologists, but a substantial number of dermatologists as well as others, for example, people we are calling methodologists, geneticists and so forth, and patient group representatives. There is a greater preponderance of members from Europe than North America.
This is the representation of countries that are within GRAPPA. I will say that there is every effort to make GRAPPA as inclusive as possible in membership. So, an example of membership will include people, for example, who have not yet necessarily established a position in the literature; they are not the key thought leaders you see on podia in various places, but some of the more up-and-coming dermatologists and rheumatologists who will e-mail us and say, you know, “We’re starting to do some collaborative work with our dermatologist or rheumatologist in our center, or we have established a clinic for psoriatic arthritis that combines both derm and rheum, or we’re establishing a spondyloarthropathy clinic—we’d love to start to participate in the interchange.” So, there are a number of people who are coming in via that mechanism. We will get into this in more detail.
These are just some further opportunities to meet during 2005 listed here with some that may not occur, and some additionally that may occur, to be discussed. I should mention at this point that yesterday Gail Zimmerman and others were involved in a meeting with the International
Federation of Psoriasis Association, and there is a discussion underfoot about having a large

international psoriasis and psoriatic arthritis meeting occur in June of 2006. Perhaps before the end of the morning, Gail can share more about that.
So, with that, let me launch into—so what I would like to do here is in a very rapid-fire succession, just show you some slides related to drill down a bit more into the material that
Dafna has shared with you about some of the work in progress. Most of this is not yet published but is ultimately going to be published within the next year or two. So these are some of the examples: the classification scheme for psoriatic arthritis, evaluation of psoriatic arthritis composite outcomes, determination of the minimal clinically important difference or MCID or function in psoriatic arthritis, development of the participate measure, determination of patient global assessment, axial and enthesial dactylitis assessment, and treatment guidelines.
So first, on classification scheme, the major classification that has been used is the Moll and
Wright scheme and then Philip Helliwell is leading this CASPAR initiative. This is basically the
Moll and Wright scheme from the mid-1970’s, with five different subsets of inflammatory arthritis in association with psoriasis and usually negative rheumatoid factor. The reason for wanting new classification criteria is in order to try to get away from the issue of diagnosing patients who have coincidental rheumatoid arthritis and psoriasis or coincidental osteoarthritis and psoriasis or ankylosing spondylitis, etc., to have more precise epidemiology and prove prognostic information and facilitate research. Philip led this effort in 32 different international centers in which we each contributed patients, all told 600 patients we felt had PsA and 600 controls, at least 50% of which were RA, and we gathered a number of pieces of information including clinical and historical exam data, radiographic data, DNA samples, and serum samples for lab work so that these more up-to-date techniques could be included in the classification. And these are the various types of biostatistical analyses that have been applied. Just to give you some sort of high-level data that is just coming out—and we will see more of this data presented at
EULAR in June—this gives you an example of the PsA cases in this color here and controls here, so you can see, for example, that dactylitis, enthesitis, and DIP involvement as you might expect do help distinguish these conditions. There is going to be developed a large analysis of diagnostic odds ratio which is defined here, and just to show you a few examples of the DOR, psoriasis itself stands out as having a very predictive DOR of 581, nail dystrophy slightly lower, and family history of psoriasis DOR 9.2. Dactylitis yields a DOR of 19.3. DIP disease DOR of
6.4. I am just giving you, again, some high-level data. Any tender enthesis DOR of 3.8, inflammatory heel pain DOR of 2.7 and so forth. So that, again, is the kind of analysis that will ultimately be presented so that in the new classification scheme, it will read “If you have X, Y, and Z elements, then you more likely have psoriatic arthritis than say, rheumatoid arthritis.” So that is ultimately going to be the outcome of that particular project.
This is a project that Dafna alluded to and Christian Antoni who is here was the primary investigator in this project. Christian enlisted the aid of two methodologists to analyze the raw data from the etanercept and infliximab Phase 2 trials which were very comparable in terms of patient groups and, as it turned out, outcomes. The two types of analyses: one was the receiver operating characteristic analysis; the other, a responsive analysis in standardized response means.
I will just show you a little bit of examples of data from that.

This is one of the ones that was Christian’s favorites to show. As he has explained it to us, the more right-angle this shoulder is, the more specific and sensitive is the instrument. And one of the things that has been utilized in rheumatoid arthritis trials is something called the DAS28 which looks at 28 joints. As it turns out, the DAS28 was essentially the most sensitive and specific composite criteria for joint assessment. Now, one of the caveats of this is that when you bring patients into a trial, we do not just count 28 joints in a PsA population. Christian analyzed that we would have lost some 20% of our patients in our trials if we had just limited ourselves to those. So you bring patients in based on the total joint counts of 68 tender and 66 swollen, but you can do this analysis on it and come up with this degree of sensitivity and specificity. This is what the raw curve for 68 tender joint count, slightly less sensitive and specific, and swollen joint count. This is an example of CRP—this is another one that Christian had an interesting time showing to us, which was that the more you get this kind of curve, as he puts it, the more it is like a 50/50 toss of the coin in terms of sensitivity and specificity. So the CRP and, to a slightly lesser extent, the sed rate, is a less-sensitive measure in PsA.
Comment from the audience.
Well, I mean it is less specific, I’m sorry. Correct. You should jump in here, Christian, as I butcher the presentation. Feel free.
Then this is a listing of the various instruments in terms of discriminate ability, showing that the
EULAR 28 which is an application of the DAS28, using something called the EULAR Response
Criteria, was highest with the ACR20 in this position and the PSARC in this position. Again, I am not going into these in any detail, but just showing you examples of the kind of work that can come out from analyzing some of the trials that we are doing.
I just want to mention that we are interested in using an enthesopathy outcome measure, and there have been various ones put forward including simply pressing on the Achilles tendon and the plantar fascia, but this one is one developed in Maastricht for ankylosing spondylitis patients in which these 13 sites indicated in red are sensitive and specific in terms of ability to assess enthesopathy, and this is an instrument that will be used in an upcoming trial in PsA.
I mentioned the minimal clinically important difference. This is something that we have seen quite a bit of research on in rheumatology and it asked the question, “In a given disease parameter, how much change is clinically important to the patient as opposed to simply statistically significantly different?” And it turns out there are more than 20 different methodologies to measuring MCID, and the MCID for rheumatoid arthritis, as it turns out, is
0.22 of the HAQ score out of a total of 3.0. So is it similar in psoriatic arthritis, or is it different?
So we did an analysis using the etanercept Phase 3 trial, presented it at EULAR this past year, and incorporated in that trial a question in which we asked patients “How important to you is the amount of change in your physical limitations?” and came up with this result. We did it also by a second method which is purely statistical, where you do not ask the question but do a statistical methodology, and the take-home message, as the patient rating-based MCID turned out to be
0.30. Now this needs to be confirmed by looking at it in larger number of studies, but it is an approach that I think is an important one, and you can apply MCID to different parameters of disease activity.

Participation has been mentioned in which we are looking are measurement of participation in all aspects of life including work, family, social, religious, etc. It is being mandated from the WHO,
International Classification of Function Group, seen as involvement in a life situation. So, this is a diagram from the WHO site, showing where participation falls relative to activity, capability, and bodily function, health condition, personal and environmental factors all influencing. So the action plan that GRAPPA has set out for developing this type of tool is outlined here; this process is being led by Will Taylor, and Henning Boehncke who is here will be participating in that process as well from the dermatology side. There is a structured process that will occur over the course of two years including patient questionnaire exercises, Delphi exercises, and so forth.
The patient global question, the question that Alberto Cauli of Italy will be leading in this regard with other members of GRAPPA, is this one: when you ask the patient global question and have them mark on a VAS scale, do you ask, “In all the ways in which your psoriasis and arthritis as a whole affect you, how would you rate the way you feel at this time?” Do you ask that single question, or, do you ask three different questions, or do you ask two different questions? So, we actually kind of stumbled into this. Many of us were not even sure what our study coordinators advised our patients when they were asked to fill out a patient global. Basically, many of us were probably just letting the patient figure it out themselves, and that could be a reasonable way to do it as well, but we wanted to subject this to some more careful analysis, so that project is underway.
There is a group led by Oliver Fitzgerald from Dublin that is going to be standardizing what histologic and immunohistochemical analyses used in skin and synovial biopsies are done in translational studies. Wolphrom Steri at this meeting expressed a great deal of interest in participating in this group, and we are very open to having dermatologists involved with this project. This is an example of some of the types of immunohistochemical markers that we want to be looking at as we do trials with different agents to see what kind of changes are wrought.
Finally, this is the process that we are going through in terms of developing treatment guidelines, appreciating that there are multiple compartments that are going to be impacted by therapies in
PsA. In milder disease, we can use these milder approaches, but in moderate to severe disease, we want to use more significant systemic approaches. And so we have been culling the literature using these different grades of evidence and coming up with some preliminary tables like this in which you look at effect sizes; is there radiographic evidence of effectiveness; what are the toxicity factors; and then coming up with an overall recommended grade and so ultimately this will be done in the form of a paper that will summarize this. The international treatment guidelines, I think, are important especially in Europe where treatment guidelines at a national level are already being proposed, and we would like to come in with an international approach to this.
So the purpose of this review was—by the way, I’ve listed a few questions that still remain out there, which we do not necessarily expect to answer but are just some of the questions that are percolating about—I think what our interest is is how do we come together, go apart, come together, go apart, between the rheumatology and dermatology communities in terms of informing each other as we learn about the differential effects in the joints, x-rays, etc. on the one

hand, skin involvement on the other, and then the umbrella between all of those having to do with patient function, quality-of-life, and so forth. So we very much want this all to be a collaborative effort. And with that, I am going to turn the podium over to Alan Menter who is going to discussing the developing of the IPC as well as other things, and then leading the subsequent discussion.
ALAN MENTER
IPC (International Psoriasis Council) – Development of Goals and Working with GRAPPA
Thank you, Phil, and thank you for the opportunity to come and discuss this IPC issue. Just before I start, I just wanted to, number one, thank all of you for coming. I know, as Philip says, it is an early hour and a lot of you have other things to do, and I know some of our dermatology colleagues are currently in meetings and hopefully will even come in the next thirty minutes to forty-five minutes. Robin, thanks for putting us altogether, and thanks to the industry for helping to sponsor this as well.
Just before I start discussing the International Psoriasis Council that is now a full operational entity, I just want to give a little background as to how this all came about. I think those of you who know me, and I think I’ve gotten to know most of you here over the last five or ten years, and some of you over the last twenty-five years—we, back in Dallas back in 1979—started our daycare psoriasis treatment center, and our next-door neighbors at the hospital in Dallas and
Baylor were a rheumatology group, and I think it became very obvious then between us that our closest colleagues, as I have said many times publicly, in the dermatology-psoriasis arena, having spent probably half my academic life and private life in the last twenty-five years doing psoriasis, are rheumatologists. There was seldom a day that went by that I was not asked to go in and see one of the rheumatological patients and seldom did I not ask my rheumatology colleagues to come into the psoriasis clinic and help us out with diagnostic and therapeutic problems. So, as Phil and Dafna said, there is a tremendous amount of overlap between our two specialties.
On the other hand, I have a feeling, as you have probably heard, that rheumatologists are far more ahead of the game—and I have mentioned this to Phil in private conversations—with organization relating to their diseases that they hold dear, that they work with—and you’ve heard some of the examples of that. And having worked with Mark Lebwohl, who is here, for the last
20 years—Mark now heads the medical advisory board for the National Psoriasis Foundation, having worked with Gail from the NPF and helped Gail with the gene bank that we established under the auspices of the NPF back ten years ago, twelve years ago, we had felt and had preliminary discussions a few years ago, that there was a place for a group of dedicated dermatologists to really do some of the things that our rheumatology colleagues have done insofar as interacting with NPF with rheumatologists, with industry, but creating an umbrella organization of dermatologists dedicated to some of the things that our rheumatology colleagues have done, and I am going to try and run you through this.
We had an initial meeting a couple years ago—some of you were there—in which we had representation from industry, from dermatologists, from the National Psoriasis Foundation, to try and see whether we could--

Turn tape over
HENNING BOEHNCKE(?) :--evidence-based guidelines, nothing else, but evidence-based guidelines. With regard to psoriasis in a narrower sense, from a dermatologist’s point of view, there are guidelines out there that are evidence-based, and maybe they are not good enough. The question is if you are serious about evidence-based guidelines, this is a titanic task. And therefore, I am sure you are aware that the German Dermatology Association really has generated its own institute for that. We have an institute for evidence-based medicine and dermatology that is headed by Professor Johnnie and we are about to generate an guidelines so that is basically the gold standard of guidelines for treating psoriasis. We found it extremely difficult even with that professional backbone, so to speak, to approach psoriasis, even from a dermatologist’s point of view, because we stumbled onto all kinds of problems like, what about mild disease? what about topicals? And that is something that I don’t think one can just say, “OK we’ll do it” because one really has to come up with all kinds of flanking actions to make sure this will really work. My question is, did you check on the national—so to speak—on the national bases that are perhaps already there to build an international guideline on that.
Because of my own personal experience, my impression is that this is basically eating up everything of your time that is left, besides your ordinary job if you do it properly. Even if you try to stay very focused, even forgetting about mild disease topicals, pediatric populations, any other type of psoriasis other than and things like that.
ALAN MENTER: You know, I would like you to maybe answer your own question because you have worked with Will Taylor, insofar as you know in psoriatic arthritis as well guidelines as to how you feel that the German initiative which is probably further ahead than any other at this stage, could be taken internationally maybe under the auspices of GRAPPA. I know, Phil, you have given this some consideration. So I am going to ask you to maybe answer your question with Phil’s help relating to internationalizing the things that you are doing.
PHILIP MEASE: Well, a couple of things. I think both Alice and Henning have contributed to, and will continue to work with a community of GRAPPA that is led by Art Kavanaugh and Chris
Ritchlin regarding development of treatment guidelines. In all humility, the guidelines that they are focusing on include skin as a component, as in the context of a patient with psoriatic arthritis.
I do not think that it would really be—that the committee feels it is capable of tackling the bigger question of psoriasis treatment guidelines. So that really would be something that you should take on, it seems to me, within a structure like is already well underway in Germany, it sounds like from what Henning has described. And then maybe within the IPC, taking that German lead and establishing a committee for doing psoriasis as a whole.
ALAN MENTER: Within the nine working committees of GRAPPA—is that correct? is that right? Robin, I think there are nine—I just listed a total of nine when you gave your presentation—nine working committees. Where does this, specifically when you mentioned skin and skin-related issues—has that—
PHILIP MEASE: That would be under treatment guidelines.

ALAN MENTER: That will be under treatment guidelines. That is what I thought.
PHILIP MEASE: And then in terms of outcome measures in clinical trials, we are interested in having to be able to weave in psoriatic arthritis trials with skin component, but we look to you to teach us about that and develop that.
ALICE GOTTLIEB: I think actually the other one is as important, and that is, I am always disappointed when companies test drugs in psoriasis that are systemic and do not measure anything for psoriatic arthritis. So that, I think it would be very, very useful to have some kind of a screening—may not be as good as the DAS or ACR—but something that would be easy enough for derms to do to get an idea, does the drug work at all in psoriatic arthritis. And I think that is equally important.
PHILIP MEASE: Absolutely agree. Great point.
ALICE GOTTLIEB: And I also—about the whole issue—I know I have expressed this before;
I actually don’t think that—since at least in the United States the FDA is saying they’re interested in only clear or almost clear for psoriasis; we have perfectly good scores and can do that now. They’re not interested in medium responses. We need to develop tools that in practice are useful. PASI is not useful in practice. And so, because what I’m seeing with some of the third party payers is they’re asking for us to demonstrate efficacy of the drugs. They don’t want to hear it works better; the patient is happy. And what I’ve been doing, and which they’ve been happy with so far, is I’ve been doing a static PGA which is pretty much idiot-proof; I mean, it’s not great, but it’s not hard to do. And in addition, I’ve been doing body surface area, and they’ve been accepting that and it doesn’t take long. But whatever we develop on both sides has to be something that is practical in the clinic; otherwise people are not going to do it.
HENNING BOEHNCKE: There is also the regulatory guidance, or what they call it, usually aware of this paper in the has been thrown at the dermatology community where they say that the PASI shouldn’t be done anymore. And so, all what we can contribute from a scientific point of view may or may not reach the point where it is accepted by the regulatory—to me that was shocking to see what bureaucracy can come up with by defining what kind of data they want to see, even though they send us out for comment to many, many dermatologists who clearly oppose what they got and simply nobody listens. See, the question isn’t how much effort can we put into coming up with alternatives if we don’t know whether anybody listens—even though they are interesting for studies for investigation and initiating studies with regard to the bureaucracy and how they look at the data and how they process them.
ALAN MENTER
: I couldn’t agree with you more. The only issue that relates to that is when you talk PASI scores with third-party payers, they often have said to me, why is it the PASI scores in all the psoriatic arthritis studies are so much lower entry criteria than PASI scores for dermatology? And when you tell them that the FDA allows methotrexate, etc. to stay on board when patients are entering psoriatic arthritis studies, and hence you would expect the PASI to be significantly lower because I have never seen a psoriatic arthritis study in which a PASI score is over 10; that would not allow them to be included as an entry criteria for psoriasis-related studies where they have to be off systemic therapy and the PASI score goes up to 15-20. There is a

tremendous lack of understanding, as Henning says, by regulatory and third-party payers, and unfortunately, to some extent, we are going to be driven by them because reimbursement is such a massive issue and will be a massive issue in Europe as they go forward as well in different parts of the world.
Let me just try and focus specifically so that we can come away in the next 30, 45 minutes with some structure in hand. If we take the first evidence-based guidelines, treatment guidelines,
Henning, with all the work you are doing—and I know Chris Griffiths has expressed an interest in this—can we at least look at a subcommittee of at least exploring this without putting any extra work on your shoulders, because I know how busy you are, in creating a structure within either GRAPPA, IPC, and we can kind of work through that where we do have some thought leaders who are skilled in this arena to at least look at it preliminarily, create a committee, that we can come back in a year’s time and say it’s not just idle talk and we can leave here with some structure in hand to kind of go forward. So, without asking you, can I at least mention your name tomorrow when we discuss this in our committee structure, to at least give us some guidance and create some formal structure to advance this process?
HENNING BOEHNCKE: Well, of course, I would be happy, but I think the name that is most relevant regarding this because of who is heading that institute there who is basically in the
Department, is Wilphrom Steri. So he would be the person to talk to because he knows where the
German initiate stands and he is a true professional. He knows the guidelines for guidelines.
Indecipherable comments from audience.
DAFNA GLADMAN: Henning, he doesn’t have to be the chair. He certainly could be part of the committee, but he does not necessarily have to be the chair. We cannot volunteer him when he is not here. You’re here.
Comments from audience.
DAFNA GLADMAN: Alan, if I may just make a comment—I just wanted to make a comment with regards to the assessment. Right now, we seem to all be driven by what the bureaucrats in the various government committees are telling us to do in terms of reimbursement, but remember, the reason they’re telling us what to do is because we, as a medical community, have not generated valid, reproducible instruments. So if we turn around and develop valid, reproducible instruments that are feasible, like Alice was saying, that are easy to do, once we do that, there is no way that anybody is going to say that theirs is better than something that is scientifically proven. So, I think that that’s an effort that really must be taken very seriously and soon, in order for us to actually make a difference to what all these various national guidelines are telling us. So I would encourage you to take a committee, put a committee together, where instruments will be developed—some of them may be developed from something that’s already available; you may say the PASI is good for severe disease, or you may say the PASI is not good for anything, whatever. I mean—
ALAN MENTER:
There’s been a ton of work done—Alexa, I spoke to Alexa Kimball-Berger, who actually came up with a very nice paper, just recently published on how to fine-tune the

PASI and make it more accurate, etc. So there are a number of people who are looking at this, and Dafna could not be more right in saying that we as a medical community, derm and rheum, have done a very poor job of leading the way—and to some extent we have let the FDA drive it and say—and they’ve not one PASI as the original instrument, but almost by default it became the instrument of choice and the primary endpoint for all psoriasis clinical studies. So, yes, Dafna is completely correct; we as a group have to take the lead and I think part of our charge today that Phil has given me is to kind of steer it in a way, that again in the next 30 minutes we can come away with a formal structure that looks at the second issue; if we look at the outcomes issues and now look at basically different skin instruments and quality-of-life data; how can we create a committee of people, well-intended people, who have the wherewithal to come up with a better instrument. Alice—
ALICE GOTTLIEB: I would like to add, though, and we talked about this when we talked about this IPC concept with Don Pool and myself a number of years ago. One of the things that seems to be left out of here is advocacy. And one of the points that I think has not been made to anybody yet, is the burden, the cost to society, of psoriasis and how treatments make the cost to society, because at the end of the day, it is about money. And one has to prove that psoriasis patients cost the employer and the United States, the government maybe—who pays the health bills in Europe—that it costs money to society for patients to have psoriasis: they lose time from work, they are not as productive when they are at work, and that treatment X makes that better.
Nobody has really addressed that. There have been some attempts in rheumatoid arthritis, the
Wonke Paper, that attempts to say that people are more productive—they show up at work more, they work more hours per week—until we show that—and that is something that could be done as a group—I don’t see anywhere in this—and that is something that I would be very interested in doing. We have to show that psoriasis costs money to society. And if it does not cost money to society, that is significant—we will never win it. Because we are competing with other diseases.
So I think that should be a very high priority. I would put that way ahead of some of the other ones.
DAFNA GLADMAN: So in GRAPPA we actually have a subcommittee that is called economic impact and you’re on it.
ALICE GOTTLIEB:
No, I’m not—I’m on the guidelines—
DAFNA GLADMAN: Now you’re on it.
(Laughter)
ALICE GOTTLIEB: But frankly, this should come from derm. It should not come from rheumatology.
DAFNA GLADMAN:
We’re doing it for psoriatic arthritis. And what I’m saying is, there has to be what Alan is actually talking about—we’re trying to get some parallel committees that work on psoriasis and then eventually mesh all of this together.

ALAN MENTER: Alice, just before you came in, there was a kind of—Phil, you mentioned it or maybe Dafna did—the WHO International CF Committee that, again, I think has been spearheaded and the Delphi thing that Robin e-mailed all of us about last night, specifically relates to those issues, Alice, that you are mentioning. Insofar, as whether IPC—I mean, we have
Gail here from the NPF who is kind of the lead advocacy person internationally, and so that was a deliberate area that we will partner with advocacy people, but not specifically look at the IPC as the focal point of advocacy. Because we have, you know, enough people doing advocacy work, particularly under Gail’s direction. Not that we will not do advocacy, but it will be done certainly in partnership.
ALICE GOTTLIEB: But this requires—not well-intentioned people to go lobby; it requires scientific data. And it belongs in—whether it belongs in GRAPPA or IPC, whether it belongs—it belongs in a community of experts.
ALAN MENTER:
Great, well then that’s—you’ve volunteered yourself for a committee and
Alice, I think we would be delighted to—we need a skin—hm?
Comment from audience: --economic impact.
ALAN MENTER: Yeah, we need exactly as Alice says, something driven by derms so look at the economic impact of skin, vis-à-vis the arthritis portion that GRAPPA is doing currently.
Phil—
PHILIP MEASE:
So I think that’s an excellent example of a committee that will probably be exactly in parallel in IPC and GRAPPA, because there is already quite a bit of analysis going on regarding PsA analysis, and so that much is becoming mature, the scientific analysis of economic impact. It’s being done with actually each of the major biologics that is being developed in PsA, but my sense is that there will be similar models in the studies with pure psoriasis. And so it would be good to have a committee within IPC looking at that, and then one or two individuals that are e-mailing each other back and forth and when we have conjoint meetings, meeting together and co-presenting the data that is emerging in PsA and the data that is emerging in psoriasis.
Now, in another arena—let’s take participation, for example—that really is something that is being heavily spearheaded by Will Taylor in our group. So that might be one where, say, if
Henning is interested, as he has expressed, in participating in that project, that’s more of a
GRAPPA-driven process because that involves a great deal of work including going to international meetings with Gerald Stuckey and others, and there is a whole research framework around that. But it seems to me that the exactly parallel process could occur in IPC, so it would be up to you all to determine what the committee structure would look like.
ALAN MENTER: And I think the structure, Alice, again before you came in and just for everybody else’s benefit—if I remember the numbers, there was—“formal members” of
GRAPPA, which is really anybody who has expressed an interest in belonging to GRAPPA— there was, what, 76 rheums and 51 derms and a lot of allied people as well. And I look to us, you know, and the IPC is certainly creating—we just created an infrastructure to get this thing

underway. And then once it is fully established and we have our committee structure in place, then we will create all the members and committees, etc. that we are looking at in parallel. I think the critical way is—I think you have it down in the next portion of the meeting—I really did not want to spend too much time on working in committee—because if we can come up away with two working committees here that we all feel comfortable about, because there are so many other areas that we could come up with, but I think the two that I brought up are areas that are dear to your heart and I think we can certainly benefit from.
So, let me summarize my charge, which is to come up with subcommittees and see whether we can—we have established Alice under the economic committee; you will help chair that.
Henning, you will give us some information related to evidence-based treatment guidelines and steer that.
Discussion.
DAFNA GLADMAN: The reason the assessment is so important is, in order to get appropriate information out of clinical trials, you have to have important tools. In order to calculate your economic impact, you have to demonstrate how the assessment has improved by a drug vs. the side effects of the drug vs. the cost of the disease without drug vs. the cost of the disease with drug. So, if you do not have the recognizable, widely accepted, easy-to-do instruments, it is going to be very difficult to do anything else. That is why we have spent a lot of time in rheumatoid arthritis developing the instruments, The ASAS, the ankylosing spondylitis group, is spending a lot of time on evaluating back disease and we’re grappling with whether we just borrow from these—but we have to validate those in psoriatic arthritis to make sure that they actually work as well as they are supposed to. So, you may not think it important, but it is probably the most important item in order for everything else to, kind of, sit on it.
ALICE GOTTLIEB: I think it’s true, but I don’t think we have time. I mean, it took ACR—I remember, what was it, in the early 90’s, that people started to get together—maybe even in the late 80’s, somewhere around there—people started, frankly spurred by the biologics—started to get together—it’s been—I remember when I—certainly the early 90’s it was already that people were doing this—
DAFNA GLADMAN: The ACR was actually based on a set of criteria that was developed by
Harold Pollis in the 70’s.
ALICE GOTTLIEB: Yes, but—
DAFNA GLADMAN: And that was based on an ACR joint count which was developed in
1949.
ALICE GOTTLIEB: Good, that makes my point even stronger. OK?
DAFNA GLADMAN: But you can bypass a lot of these things because there is now a structure of how to evaluate and produce valid measurements. And you have a number of things that are already there that may need to be taken apart and together—

ALICE GOTTLIEB:
You don’t think you need to do a new study to validate whatever we come up with?
DAFNA GLADMAN: You need a new study, but you can do it—
ALICE GOTTLIEB: A couple of years.
DAFNA GLADMAN: It shouldn’t take more than three months.
ALICE GOTTLIEB:
Oh, I don’t think so. Because I think you need to talk about the long-term effects of psoriasis, not just the—
DAFNA GLADMAN: The first thing you do is you validate the true reproducibility and feasibility for a single assessment, and then all you need is 12 months to see what happens to this. You don’t need a drug trial to demonstrate that the measure works—
ALAN MENTER: In speaking to the FDA about this, I think they would dearly love us in derm to come up with better instruments. Jerry Krueger I know discussed this, when Jerry kind of gave his discussion at the very, very first meeting. He did a review of all the different measurements and instruments in psoriasis—I know that Jerry is very keen on doing something like this, and at least if we can have an exploratory committee to look at this—in Jerry’s absence I can twist
Jerry’s arm to kind of at least look at this and I promised Jerry we’d feed back to him as soon as we got back. So I will propose Jerry to have an exploratory committee done to look at instruments and see whether in a reasonable period of time we can come up with a committee and come up with a better instrument for assessing skin disease which I think is sorely lacking.
I think I will now pass this—Robin, you have made enough notes that we have three potential working committees so at least my thirty minutes up here have not been in vain.
ROBIN SHAPIRO: Treatment guidelines, economic impact, and instruments.
UNIDENTIFIED: I realize that psoriasis is a unique disease, not a skin and joint disease, a unique disease. 40% of the patients have arthritis or joint pain, and I am excited about the
GRAPPA. I think the GRAPPA will change the looks of the disease, and I am very happy to join
GRAPPA.
PHILIP MEASE: Thank you for those comments.
Unidentified from audience: Put her to work!
PHILIP MEASE: One comment I would make is I think there is an appreciation that there are some projects that can get done more easily and quickly than others, and I think one of the things that we really do want is to have multiple parallel processes going on as much as possible. And there is at least enough person-power identified within GRAPPA whereby there are successfully,
I think, a number of committees because they are delegated out among a number of different

individuals, bringing these forward. The one other area that I would say is that Henning at least agreed to participate in this whole function participation area, so that is sort of an additional area besides the three that Alan just identified.
So one question is—by the way Robin is reminding us that we need to focus in on identifying whether we want to have some type of conjoint meeting at AAD between GRAPPA and IPC in either—whether—Gail you educated us a little bit about this yesterday—about whether AAD would allow us only to have it only, say, on Thursday, or could it be on say, Friday morning, or not.
Comment from audience: Thursday is so full. We’re double-booked already. I don’t think we can add another meeting.
PHILIP MEASE:
And there’s no way around that Friday thing. I appreciate that. I mean, ACR is the same way. So, that would mean Gail giving up the usual formal dinner that follows the
NPF Board Meeting. Oh, oh, I’m sorry, Friday night. But then, doesn’t that fall under the same rule?
Indecipherable comments.
PHILIP MEASE: Oh. Perfect! Alice! Wonderful problem solving! Good idea. Is that acceptable to people? Do any of the industry people have a sense about what—if that represents a problem?
David? Alan, do you have a sense of that? Friday night, sometime during that evening, but possibly starting at 5:00?
Comment from audience.
OK, so we’ll work on—would 5:30 be better?
Comment from audience.
And is it comfortable to say GRAPPA/IPC?
Comment from audience.
OK, good. All right, all right.
UNIDENTIFIED: I think from an industry perspective, there are social events that will be going on that night, so I think there are some social events on Friday night, but they aren’t starting until later. So at 5:00 to 8:00 timeframe would actually be quite beneficial.
PHILIP MEASE: Excellent.
UNIDENTIFIED: I was just saying there are some industry social events that start around 7:30 or 8:00, so it could possibly be bracketed in between the 5:00 to 8:00 timeframe. That would work best from an industry perspective.

PHILIP MEASE: Thank you. Then the other issue which again will follow discussions of the
IPC group tomorrow and maturation of that process will be when to do a conjoint meeting with dermatologists. One idea had been floated but it may not come to pass, and that was to do a conjoint meeting adjacent to the gene-to-clinic meeting in London at the end of October in 2005, but if the organizers of the gene-to-clinic meeting feel that that is a pure meeting, that they do not want to have this as an appendage to, then another option could well be to officially have it in
Stockholm—if this comes to pass, the meeting in Stockholm—in June of 2006. Alice?
ALICE GOTTLIEB: The gene-to-clinic meeting does not get a wide attendance by dermatologists—I’ve never gone, for instance. OK, so, it’s a fairly select group of people who seem to invite each other again and again. I do not think it represents the dermatologist community in any sense. It’s a good research meeting in some respects and so—but that’s it. I mean, if you’re going to want to get derms to come, you have to do it around the AAD meeting—it’s ideal—it’s probably the best place to do it, and EADV in Europe if you want to get the European ones. But otherwise it’s not going to get a wide attendance.
PHILIP MEASE: One of the things that we have found as we have tried to plan these meetings adjacent to all of our specialty meetings is it happens a bit like today—where you struggle to find a two to three-hour time; it’s a bit fragmented; people have many different meetings; you have construction going on in the background—I mean, there are all kinds of issues. So there has been some compromise in that regard, and one of the things that we hoped for was a full, complete day, or day and a half, where we can present—
ALICE GOTTLIEB: Make it in and of itself something special—you really probably want a separate identity anyway, because you don’t have name recognition—you don’t have brand recognition—nobody knows in derm what GRAPPA is, OK? They think it’s a drink. And certainly nobody knows what IPC is. And they’re further behind than GRAPPA. So, you’ve got to find some way to get brand recognition, and that’s to do it separately—
PHILIP MEASE: It worked well in New York. Two realities to mention there: one is cost and we do need to be somewhat economical—because we are very graciously supported—but we also need to be economical—and so to the extent that we can have any meeting that people would be coming to anyway. For example, the Stockholm meeting might be a good example of that. And the other is, I know the meeting exhaustion that people have, of adding yet another meeting to their year’s group. So, again, I think this will be taken back into discussion between the boards and tomorrow, presumably, you will establish some kind of formal mechanism of bridging communication, i.e., certainly yourself, Alan, and certainly the organizational heads communicating with each other. Another issue will be access to the Internet sites and whether if you, for example, establish in the IPC a Website where communication goes on, then making mutual access to those Internet sites would be important, I would think.
UNIDENTIFIED:
Phil, I’m sorry, may I just back up to the trying to schedule the date and perhaps I misunderstood, but in just kind of connecting with my colleagues here from industry, was it not the intent to try to schedule at the AAD a joint meeting for IPC or GRAPPA? Or was it strictly GRAPPA?

PHILIP MEASE: We just determined the time of 5:30 to 8:00 to 8:30.
UNIDENTIFIED:
So it wasn’t a combination—we were a little unclear. OK, that’s wonderful.
PHILIP MEASE: I see. Robin is saying perhaps we don’t know what are the goals of a conjoint meeting. When I am using the term conjoint meeting, I am really meaning something much more substantial. So instead of a 10,000 ft. view of some of the research projects that GRAPPA is involved in, you get a close-up view where the people who are actually doing the work can take the group through methodologically how it is being done, and, for example—
Comments from audience.
PHILIP MEASE: Right. And the other point Robin is making here is that we will have actual results from some of this that is now just in fledgling stage. And then, vice versa, we would like to see, for example—a couple of weeks ago, Charles Ellis out of the blue sent me a paper that he had just completed and said, “Phil, I thought you might appreciate hearing, sort of, more about our lattice instrument.” And I really appreciated that; I know they’re smiling; going on up here—
Laughter.
So, in any case—these briefer meetings are useful for moving things a little bit further along and then allowing Internet exchange. But we are really looking for a more substantial exchange where then someone who is not very conversant with how other disciplines work can walk away from the meeting saying, “Boy, I really feel like I’ve have a paradigm shift in my understanding in this particular arena.” Somebody, a
or , for example comes away saying,
“Gee, I never knew what the whole construct of participation was about, but now this is fascinating to me and I’m going to go back to France and work on developing that there” and so on and so forth.
ALICE GOTTLIEB: Can I ask a question in general because it comes down, I guess, again to money. We now have these committees in IPC or whether there’s a GRAPPA, IPC, and the kind of work that has been allotted is not work that can be done in your kitchen, you know, doing meta-analyses of published papers. This is work that are prospective studies that take a lot of resources, whether it is statistical, or—I mean, where’s the money coming from to do this? I mean, I’m just curious—it’s very nice to make a committee that says, “We’re going to make new guidelines. We’re going to—you know, establish the economic impact of psoriasis”—I’m not going to talk about psoriatic arthritis. HELLO, where’s the money? You’re talking millions of dollars possibly. I mean, where is the money coming from?
DAFNA GLADMAN: The money actually comes from a number of sources. For example, the committee work itself through GRAPPA—we do a lot of things on conference calls and that is underwritten by GRAPPA. In terms of doing specific things—like Will Taylor and Delphi process now—it is partially funded by the World Health Organization; it is partially funded by some grants that he got locally; and GRAPPA will probably have to supplement it with some things. The proposed study that we have on international validation of measurements of joint

counts, for example, in psoriatic arthritis, we are going to have to apply for specific funding. We make it as a research proposal and apply for specific funding. But, I mean, you are absolutely right. It cannot be done without appropriate support. The economic impact, as Phil was mentioning—one company has already done an economic impact and now another company is interested in doing it, and what we are probably going to do as part of GRAPPA is actually doing a meta-analysis of all of these, because we’re not interested in one drug; we’re interested in everything being available to all our patients so we want a class of drugs to be recognized as important. So we will probably do that as part of our work and, again, we will have a budget once we figure how exactly what we’re doing. We will identify a budget and then we will have to see where we can get the money. But obviously we do need money to do this work. And money does not grow on trees.
ALAN MENTER: I think the important thing—I would imagine industry who are here who sponsor GRAPPA obviously has interest in insuring that we can produce goods just like money that goes to different organizations that produce goods from a not-for-profit point of view. We have to come up with specifics—I think one of the problems we have had in the initial, kind of, halting way of establishing organizations like GRAPPA and IPC, is what gives the best results for the income for the money that industry sponsor and that other people sponsor—for instance, we in IPC, are purely 100% at this stage sponsored by one person who has funded our organization. So what can we as a group—GRAPPA, IPC, NPF—produce that is worthwhile for the hundreds of thousands, if not millions of dollars that industry is providing to different organizations like GRAPPA and come up with things that are meaningful, both for industry as well as for patients obviously. So I think we need to, you know, steer clear of petty jealousies; we need to stay clear of different organizations fighting for turf battles, and mutually come up with the best ways that we can approach different organizations, be it the NIH—and I had a long chat with Vera Price last night about the registry for alopecia—that is totally funded by the NIH.
Why has psoriasis not had things like that—NIH do sponsor some things for psoriasis, genetics, etc. So I think that the bottom line term is as we go to people and ask for sponsorship, we have specific goals and ideas that we can accomplish; that we don’t just sit around the table and talk committees and talk about things—but we can come up with guidelines and give ourselves specifics and say, “This is what we’d like to achieve in the next five years. Or this is what we like to achieve in the next year.” And I think part of the goal that Malia and I have, and I know
Gail has, and I know GRAPPA has, is really making very sure that we can produce so that we are not just “sitting around here talking and wasting everybody’s time and money.” And I think that is part of the issue today was to come around, come out with specific ideas, specific committees. Then whatever funding is needed, hopefully we will get the funding—but come up with meaningful outcome measurements that are important to all of us.
I know Malia has to leave so I know she wanted to say something.
MALIA TEE: I just wanted to say, along the same lines as money, we also want to be conscious of people’s time and invite them to participate in events where we do have very specific goals in mind and we actually are producing things that are worth people’s time and effort. I just wanted to clarify quickly that from our perspective, a joint meeting—our structure is our board that guides the agenda and vision of the organization. And our group of counselors is really there to provide substantive expertise on specific programs. So if we do decide to have a joint meeting,

there would be representatives from the IPC there that are empowered to make decisions on behalf of the organization and that would report back to the entire group, but we would not likely invite the entire council to attend such an event.
PHILIP MEASE: Other comments before we come to a close. Thank you very much for coming out this morning, appreciate it very much.
ALAN MENTER: (TAPE #2).
We had felt and had preliminary discussions a few years ago that there was a place for a group of dedicated dermatologists to really do some of the things that our rheumatology colleagues have done insofar as interacting with NPF, with rheumatologists, with industry, but creating an umbrella organization of dermatologists dedicated to some of the things that our rheumatology colleagues have done, and I am going to try and run you through this.
We had an initial meeting a couple years ago—some of you were there—in which we had representation from industry, from dermatologists, from the National Psoriasis Foundation—to try and see whether we could help coordinate some of the issues that we will discuss shortly under the umbrella of a group of dermatologists who were committed to this disease called psoriasis. So, that’s kind of an introductory slide.
So, to introduce this entity of the IPC, I think you’ve got it here and Malia Tee, who I’ll introduce just shortly, has copies of this for all of you who may be interested and you can just give her your e-mails and she would be more than happy to e-mail you a copy of this presentation. I think this really spells it out pretty well that we are now officially a not-for-profit organization, and Malia can talk to this—a worldwide group of doctors dedicated to advancing psoriasis research and treatment by literally doing what has been done here—what GRAPPA has done, what OMERACT has done, what a whole lot of other groups have, what Crohn’s disease patients have done, what neurologists have done with MS—I think the time has come for us to do in dermatology as well, so that hopefully in the years ahead we do not have to be faced with people with end-stage mutilating psoriasis or allow patients to develop von Zumbusch psoriasis, and try and look at ways that we can get the word out that this disease of psoriasis is worthy of education, collaboration, and innovation amongst all of us.
Now, you may ask who is involved in IPC, and I’m going to run through this: the original board is constituted—we have a board of myself who was given the role of kind of helping get this started as President, and basically Scott Ginsberg. Some of you may have met Scott Ginsberg—
Scott is a patient—he does not mind saying he’s a patient with psoriasis and psoriatic joint disease, on active therapy for the last twenty years. Scott has to some extent driven me to take an active role. He actually about a year ago had representatives from industry, dermatologists, come down to his home and discuss the various aspects related to creating the IPC and has helped me—he is based in Dallas; he’s a philanthropist; he gives a tremendous amount of money to different organizations—and has felt long-term (he’s fifty years old) that at this stage of his life he has the financial resources and dedication to help make this disease what we believe it should be. So he has given us our initial seed money and seed growth money to this. He is a lawyer; he has a great deal of interest in healthcare. He actually in his early days, when he was a law student

in Georgetown in Washington, D.C., basically helped Kennedy with healthcare matters and did a lot of advocacy work on behalf of a lot of organizations when he was working there, and has a great deal of input as well in national governmental policy. I’m going to ask Malia to introduce herself shortly. These are the three physicians—myself, Chris Griffiths, whom you all know, and
Craig—who have helped put this altogether. And then finally, we felt, seeing Melody Young has worked with me for the last probably fifteen years; she is the incoming President of the Derm
Nurse Association; she is very active on the National Psoriasis Foundation; she spends all her working time working with psoriasis; she has her Nurse Practitioner Degree. I think those of you from industry who know her recognize that she has spent a great deal of time and energy with psoriasis.
Now the international grouping is actually very similar to what Phil showed for GRAPPA insofar as we have created a list of “counselors”—this is a legal term that Malia felt we needed—and basically so we really have some legal aspects that Malia, who is also an attorney by profession has helped us put together. So this is a list of people, and we try to make it as geographically neutral as humanly possible, with representation from Europe, Latin America, Brazil, Asia,
South Africa—so some of these names I am sure you recognize. As we go through this, I also want to say a thank you, Professor John Hilli Serrah who is President of the EADV this year was actually instrumental in us getting this room here today, and he sends his best wishes to everybody but has other duties to fulfill this morning.
So let’s go through what we are hoping to create. I think this aspect is kind of foremost in all of our minds—all of us who work with psoriasis—rheumatologists, dermatologists, patient advocacy organizations, the NPF—I think have realized that we need to raise international consciousness of this disease. In order for us to really—all of you in industry—get to where you want to be, basically all of us have to get the word out that this is a disease of major proportions.
For those of us who have been in the trenches for the last two or three years, working to get approval for drugs that rheumatologists can write all day long, we in dermatology have struggled. I think it is true to say it took me sixty days when Amevive was approved back in
January of 2003 before we got our first patient approved for treatment. So it has been a massive struggle for those of us in the trenches to try and get the awareness raised in third-party payers, governmental agencies, and I know the Europeans, who are now just getting their drugs approved, are going through the same process with their national agencies. So I think this is something that we look at very, very carefully, that we have to explain some of the issues that I think Phil has discussed that the quality-of-life implications of this systemic disease makes it worthy for us to provide care for our patients along these lines.
I think this is something that, speaking to John Voorhees recently—I think all of us recognize that John is probably in North America at least, the father of psoriasis innovation and research and spent thirty years of his time and has created such a dramatic avenue for research in psoriasis that he has spent half of his academic life or two-thirds of his academic life on this, and that he is very dedicated, as we are all, to actually promoting scientific discovery and treatment innovations, and doing some of the things that have been mentioned already today.
From an advocacy point of view, we really want to work with National Psoriasis Foundation, the people, to help create access, the most safe, most effective, and preferred methods of

managing psoriasis. And from a personal point of view, I think those of you in industry who know me, hopefully recognize that I am taking a role of a patient advocate with no specific goal of trying to push any one individual company to the fore, and that all of us have to raise the ship so that all the companies involved in psoriasis research and treatment will hopefully help get this disease to where we want it to be. So we have to get better access for our patients and for us physicians. And I think the biggest problem we have in dermatology, as compared to rheumatology, is that we in dermatology—and I think that it is happening broadly internationally now—have so much more things going on in our lives outside of psoriasis. Dermatologists do not need procedures; we have all the procedures, unfortunately, that we need, sometimes too many procedures—so to try and get this word out to general dermatologists who are busy in their offices, who are doing all the cosmetic procedures and doing all the skin cancer work, and freezing all the warts, and freezing all the actinic keratoses—to try and get the word out that there is some worth in spending time to advocate for patients—has not been easy. But we continue to struggle through it.
And then I think another very significant part of it is we all meet regularly—all of us in dermatology meet regularly. We probably don’t have as many meetings as rheumatologists, but we have more “international psoriasis meetings” and we sit and discuss things in a kind of a round-the-bar at night time or in between meetings, and I think we need to formalize a lot of this so that we can actually create some of the avenues for psoriasis research and treatment, and that is what we are going to discuss shortly.
I think we have gone through this already. This is one of the other goals and objectives of the
International Psoriasis Council which is basically to empower dermatologists to understand psoriasis. We don’t understand psoriatic joint disease, and I think Phil and Dafna will recognize that they don’t understand the various nuances of skin disease like we do. So in some way, how can we as a group of dermatologists learn more about psoriasis, the phenotypical expression of psoriasis, help our rheumatology colleagues to learn more about it, and in the same vein, learn more about psoriatic joint disease as we go forward, both individually and collectively.
Partnership is very important. You know, there’s a lot of talk about turf battles; there is no turf battle in psoriasis. There’s not enough dermatologists to go around; there’s not enough rheumatologists to go around. Unless we all collectively put our shoulders to the wheel and work together as a unified group of people—physicians, patients, advocacy groups, nurses, researches, etc.—then I really do not believe we can reach the goals that some of us have for this disease called psoriasis. I think one of the areas that IPC would like to play a role is to partner with all the major stakeholders that I have listed here.
I do believe we have been lacking in dermatology, in psoriasis specifically, to have a group of physicians who really have an impartial way of looking at some of the outcome measures and do some of the objective work that our rheumatology colleagues have done and take this disease from a psoriasis perspective to the next level.
OK, with that in mind, just before going through this, I would like to introduce Malia—I promised Malia that basically before I discuss our plans I would like to introduce Malia Tee who has single-handedly taken the IPC on as her project. She is a fulltime employee, the only fulltime

employee of the IPC at this stage, and due to the financial resources at this stage, Scott Ginsberg who has helped fund Malia’s position, I would like to welcome Malia, and maybe Malia, if you can spend just two minutes, tell us who you are and what you’ve done.
MALIA TEE: Just very quickly, my background is in law, public policy, health policy, and alliance development. Over the years, I have consulted for disease-specific advocacy organizations, foundations, and companies in the pharmaceutical and biotech industries, and now exclusively work for the IPC as the Executive Director. That’s about it.
ALAN MENTER: OK, so we have some lofty goals. Can we reach some of these lofty goals of ours? Hopefully, with the energies we all bring to bear, we can in the years ahead. So where are we? We now are officially a not-for-profit 501 organization and here are some of the goals that we have and some of the things that we have planned. A lot of things that I’m discussing will hopefully be formally approved by our board tomorrow morning. We are having an all-morning meeting tomorrow meeting of the IPC, the IPC Board; the counselors will not be present. This is just the members of the board that I showed you earlier. We will be discussing this tomorrow morning and spending the morning trying to coordinate some of these activities for next year.
A lot of you have heard about this Registry. I know Malia has discussed this with you and I think originally Jennifer Cather, who works with us in Dallas, who has all the energy and expertise to help put this together, came to me a couple years ago and said, You know we are entering this biologic area—we are getting all these patients into biologic treatment. We have in our group alone 700+ patients taking systemic therapy between us, half of which are now biologics and half of which are other systemic patients. We try to do this with our daycare group; we then try to do it with the gene bank, which is to try to computerize all of these, and come up with a registry that we could not follow patients five, ten years out, both from an outcomes measurement, safety measurements, etc., and I now that each of your companies that are here are actually in Phase 4, have certain similar aims insofar as safety issues are concerned. So basically we thought if we could come up with 1200 patients, which we think is not a lofty goal, from international sites, and we already have commitments from a number of sites and I have had discussions with a number of you here, to try and see if we can get long-term data on our psoriasis patients. I am going to ask Malia just to kind of briefly give you a little background as to some of the issues relating to creating a patient registry that has these goals, which is longterm data on psoriasis patients. It is a very, very lofty project; it is an expensive project. But it is one that I truly believe, of all the things that we have planned, will provide us with a tremendous amount of data that will be valuable to all of us including industry.
Just to mention briefly, we have started this registry due to a very large grant, and I want to thank
Biogen, Idek, for initially providing this for their patients; we have 200 patients that we have treated with Lethacid, with Amevive, and we will use those 200 patients to kind of work our way through the Amevive portion, and then hopefully we will get 200 patients on all the other systemic drugs between all of us collectively over the next few years. And this data will be made available to study participants and others as we go through this.

Malia, do you just want to give a little background on how this is hopefully going to be put together?
MALIA TEE: Well, I can only say a very limited amount because our board is meeting tomorrow to discuss some of the issues involved. A couple of the things that are of interest is we are considering the possibility of banking blood along with collecting other data from patients from a variety of sites. We do have many details to work out, including all the legal and regulatory implications which I’m sure are running through some of your heads as you consider what the impact of an international registry might be. So, there are many issues. I would be happy to discuss them in greater detail with any of you, especially after tomorrow, once our board has had a chance to meet. So, I will have some of my cards available if you want to contact me for more information.
HENNING BOEHNCKE: May I ask a question—
ALAN MENTER: Just one second, Henning—it is important to know there are companies— private companies out there—that do this fulltime which take people through HIPAA regulations, through privacy issues, through IOB registrations, through online Web-based issues that Malia has identified. So hopefully, our board will ratify this tomorrow and we can get further details out to you. Sorry, Henning, you were going to ask something.
HENNING BOEHNCKE: Do you try to coordinate this with the samples that are being collected by GRAPPA, for example, because there are tremendous efforts—there are also many, many such banks that oversee and overlook quite a few patients that include derm as well as rheum patients. In our region, for example, we have joint effort where we follow up on patients long-term, and we have a comprehensive set of things to be collected, be it material, be it data, so all kinds of documentation—wouldn’t that be a good starting point? And, at the same time, look at the list that has been generated by GRAPPA in order to make use of what is already there.
ALAN MENTER: Yeah, we have certainly talked about that; we have talked about that with our rheumatology colleagues as well. I think initially the registry as constituted will be specifically— we will certainly have an arthritis portion of the protocol; in other words, it is an extremely long, lengthy questionnaire, and having done this with Gail for the gene bank, we do have ten years of experience of running a gene bank for psoriasis with all the implications relating to it. Yes, certainly we will be looking at how we can partner with lots of other people—rheumatologists—
Dr. Gupta had to leave but he is in Canada; they’ve got derm there; he’s got a registry of 900 psoriasis patients that will be cooperating with him; Dr. Griffiths in the U.K. has a similar registry; Dr. Steri, yourselves, yes, all of these are people that are hopefully going to be participants, either directly into this registry or in partnership, very much so.
OK, so that is our #1 goal, and certainly this will be a five-year program that hopefully we will get board approval for tomorrow.
We had thought that with so much work going on in the psoriasis arena—I think rheumatologists have had, as I mentioned earlier, a leg up on us insofar as clinical trials have been concerned. We really never have had as much effort and noise put together in the last five years that we have

had recently in the last few years. There’s probably seldom a week goes by or seldom a day goes by, that I am not called by a colleague somewhere, “How do I get involved in all these clinical trials that are going on in psoriasis?” And now, we have all you major players, the pharmaceutical industry, pushing Phase 2, Phase 3, and obviously Phase 4 studies, investigative, initiated studies—but a lot of us dermatologists who have not been schooled in clinical trials come to these clinical trials meeting really with very little insight as to what it really takes to run clinical trials. And I think we would like to really put this as a suggestion that came together at some of our initial meetings, that could we put together a two-day program on clinical trials and take all the regulatory issues, get people from FDA, CROs, nurses, and all the people that work together and really do this as our first annual educational symposium, is to create a dermatology clinical trials meeting and already we have an agenda for this that we have put together that, again, hopefully will be ratified tomorrow. So we can actually put this—and we already have a date and plan for this. And then from year to year, we will decide mutually on different things.
But I think this will be something of great value to clinicians and to industry as well. At this stage, until we get it ratified, we will let you know, OK. We will get all this information approved as of tomorrow, hopefully, and we will get that out there after.
OK, Chris Griffiths has long felt—and this feeds into some of the issues that I would like to talk about when we come to committees—that we in psoriasis have really not done a great deal of effort to work—we all talk about different subsets of clinical psoriasis and in every clinical trial we are faced with this issue of phenotyping our patients with psoriasis. In other words, what is standard chronic plaque psoriasis that you guys and industry need to know about, the dermatologists need to know about, but yet we don’t have a good way of phenotyping our patients and helping researchers, rheumatologists, industry, insofar as the different aspects of this, and this is something that has already been put together—Chris Griffiths will chair this in
Europe next year and we will have a group of about ten to twelve leading dermatologists coming together to try and facilitate all the different issues that we are faced with on a day-to-day basis, leading to phenotyping, and this has led already to a great deal of response from our colleagues who are very keen on participating in this.
We felt, just like others have done in other subspecialties, that there is probably a need for us as dermatologists to really more carefully analyze what is going on in psoriasis research, and look at some of the important discoveries that are out there, and feed this out to the dermatology community and to the general medical community as well. And this will be a semiannual review.
For those of you who have participated from a dermatologist’s point of view and industry point of view in some of the residency educational symposia, both at our local institutions and generally, I think it is true to say that—in fact, at a meeting this past weekend that Craig
Leonardi chaired—and I must say I gave Craig credit for running a very tight excellent two-hour residency symposium at one of the local meetings at one of the national meetings that were held, in which he gave a very unified and very, very broad-based clear, nonprejudicial look at all the different aspects of psoriasis—that he asked for hands to be raised amongst the 100 residents in the audience—who was using biologics in their clinical training program. Less than 20% of them that I counted put their hands up. So there is a tremendous, I think, lack of training in residency programs, and Chris Griffiths and our European colleagues tell me the same thing, that the majority of residents who are coming out are all lacking in some of the basics of the biologics

particularly, and of psoriasis in general. And we felt that possibly doing a two-day symposium in different parts of the world for residents in training, for junior faculty, for fellows, and also putting together competitive aspect to this, would be very, very valuable. And having spoken to a number of chairmen, chair people, chair ladies of different departments nationally and internationally, I think there is really a feeling that this can be sponsored, hopefully by different organizations, but that we as dermatologists need to come together to do this in an equitable fair way so that we can actually teach our residents this in a way that we believe is fair and honest.
So, with that kind of rather big agenda, here is a projected timeline for this, just to answer your question, Robin. This is what we have projected so far is that we will hopefully initiate—we have initiated this registry already, but we will enlarge the scope of this registry hopefully; the clinical trials program is the first part of the year; phenotyping roundtable is also the first court of the year; then we will have our first semiannual review; and then look at a specific date for this educational symposium as well as a site for this. Most of this has already been organized and will be, as I said, approved tomorrow.
So what are the next steps? Hopefully, after our meeting tomorrow, we will be able to, through
Malia, kind of disseminate some of the knowledge as to specifics relating to these different aspects of our organization, and hopefully we will welcome feedback from industry, from all of you, from dermatologists, from rheumatologists, as to how you would like to get involved in this and how we can take this to the next step and part of the next part of the meeting is going to be how does IPC, how does GRAPPA interact and coordinate some of the things, that we are not duplicating our efforts. And hopefully this is a picture taken just from the recent trip back to my native South Africa; this lion was very, very content; it was mating season. So I thought that possibly we would not be content in that the next five years, I hope the IPC will be roaring loudly. Thank you very much indeed.
Applause.
PHILIP MEASE: The next portion will be open for discussion. And the question is, do we want to grab some coffee and then—or launch right into discussion? Who wants to take two minutes to grab some coffee? OK. Two minutes and then let’s come back to our seats.
Something that we want to be grappling with is meeting either next year or immediately thereafter as a conjoint meeting between IPC and GRAPPA so that the rheumatologists and dermatologists can more formally present to each other as opposed to this sort of telegraphic way in which we can with these few hour meetings adjacent to meetings. So, Gail, perhaps you could just say a word about the ideas behind the International Federation meeting in June, so that that can be part of the equation of the discussion.
GAIL ZIMMERMAN: Hi everyone, I’m Gail Zimmerman. I am President of the National
Psoriasis Foundation. I am also the Vice President of the International Federation of Psoriasis
Associations which is an organization that represents about 25 foreign psoriasis patient organizations around the world. Most of them are European, but we are attempting to get organizations developed in Asia, in Africa, and South America, with an effort to try and help patients in those countries have organizations. So we are actually adding several associations

from those areas this year. We have for a long time wanted to have a way for these patient groups to participate with the doctors at their meetings. So the IFPA leadership got together last year and we discussed the idea of how do patient groups meet with the physician leaders and nurse leaders and health professionals, and we decided to approach some of the companies and some of the doctors, such as Dr. Mease, Ken Gordon, Mark Lebwohl, and talk to them about how can we have such a meeting. So we are in the planning stages of this meeting, and the purpose of the meeting primarily would be to bring patient groups together with physician leaders and share ideas about how we can work together, share information on research progress, the status of treatment and care in other countries, and to bring together as many doctors and nurses and patient groups around the world as we can, with the idea of also raising awareness about the disease and bringing all these people together in a world conference which we scheduled for the early part of June, June 1-4 of 2006 in Stockholm. It would be the first time that I am aware of, since probably 1983, when all the patient groups met with as many doctors as we would like to in this case. I think Dr. Farber at Stanford was trying to do this and in 1986 there was such an attempt—there were patient groups at his meeting. But we would like to try that—resurrect that vision again, because I think the patient groups have a lot to offer. And I think they in turn would feel encouraged and motivated by talking to doctors and seeing others, and they could obtain ideas on how to grow. And I think they could be helping advocate in individual countries for insurance, to help raise money for research, and just help in a number of areas, and it just seems like it is appropriate to have such dialog, especially now. Philip Mease is co-chair of it along with Dr. Ken Gordon from Loyola University.
PHILIP MEASE: So, Alan, do you want to—
ALAN MENTER: I want to congratulate Gail. I think one of the things that has come about that
I think we may need to discuss and get help is that, as Gail said, the late Gene Farber, who some of you may or may not know, who was probably the father of the international psoriasis symposia that he started, I think, back in 1972, when he had his first one at Stanford, and I remember as a youngster going—staying on the Stanford campus in 1976, I think, for the second of his symposia that he then took around the world. But after he left Stanford and with his demise thereafter, exactly as Gail is saying—putting together a massive effort for an international meeting with advocacy and with patient groups, etc.—has fallen by the wayside. So
I certainly congratulate Gail in taking the initiative. I think one of the things that we all in dermatology need to look at is there is a ton of different “meetings” around psoriasis taking place around the world. We just had the Paris meeting recently; there’s the gene-to-clinic meeting that
Dr. Barker runs with Dr. Griffiths in London every three years, and there’s a number of annual meetings that are held in the U.S. with Dr. Rennick and Dr. Maybeck taking over. And then oversee the different EADV meetings and the AAD meetings, so for the first time there is more than enough time being given to dermatology meetings, so I think, as far as industry is concerned, I know it is sometimes difficult for you guys to know where to put your resources and your energies, and hopefully with IPC and GRAPPA working jointly together, we can hopefully provide some help and energies with the NPF and putting these meetings into perspective. Phil, I think it is very important that we get this word out.
So, Alice—welcome to Dr. Alice Gottlieb. Now things will come alive—Alice has arrived.

ALICE GOTTLIEB: I just read the IPC, so I was actually very surprised by the actions of myself, Dr. Lebwohl, Dr. Gordon, Dr. Feldman, Dr. Koo—I mean, I don’t understand what’s going on here. How is this representing the community of leaders?
ALAN MENTER: Basically, Alice, when I introduce this, we certainly—everybody in psoriasis will have an opportunity—basically, we try to get geographic lists—we were limited in the U.S.,
I think, to three or four dermatologists, just like Europe. I have had discussions with many of the
European people as well who “feel left out”. There was absolutely no desire to leave out key thought leaders; I’ve spoken to Ken; I’ve spoken to Mark about this. There was an absolute basic understanding that we were going to limit the geographic representation and then create committee like we are going to discuss now, that everybody, yourself hopefully included, will come on board. So, please do not feel neglected, left out, etc. This is part of an international working group that has to have an organizational structure initially.
So, with that in mind, what I’d like to do is basically talk to what Phil and Dafna and Robin have asked me to do which is try and see if we can develop working goals and different committee structures along the lines of what has been created in the different rheumatology arena—ACR,
EULAR, etc.—and come up with areas that we mutually can work together on and see again which people are best suited for which committee structures within the organization of
GRAPPA. Now, having been at the very first initial meeting and then missed the subsequent meeting because of the ice, etc., in New York, I know Phil and Dafna have really tried their level best to try and get derms involved in different GRAPPA subcommittees and potential committees. We have had multiple conference calls that Robin has helped organize with Jerry
Krueger as well, to try and come up with a working structure within GRAPPA of different committees to take some of the issues that Dafna and Phil raised in their talk as to how derms can actually interact with us and help partnership GRAPPA in doing this.
So, we have heard already, made some careful notes, about the international guidelines for psoriatic joint disease that have been driven by GRAPPA and helped, and Alice, you were a part of that initially. But, as Dafna said, rheums probably cannot develop assessment tools for psoriasis, just like we in dermatology cannot “take over” psoriatic joint disease for guidelines. So we have to look at how we in dermatology can work on different potential committees, and the problem we have is, how many dermatologists do we have in the room here? I was going to say, five, six, dermatologists in the room here. So, can we parcel out different committees to our colleagues, to those Mark was showing earlier and I discussed it earlier with Mark, and certainly we are all overwhelmed with different committee works as it is, but how can we come together, and what are the committees that we feel are important, that can hopefully work together with
GRAPPA?
So I made a list, some of which Phil and Dafna kind of helped me with, as to what committee structures we should possibly have. I think I have touched on a couple of these in the IPC discussion, i.e. phenotypical analysis of psoriasis is certainly an aspect that we need to do; evidence-based guidelines—you want to make some notes, Robin, insofar as this—so here is just a brief list that I’ve put together. And I am going to throw this out and then welcome discussion relating to this. This is obviously based on discussions with Phil and Dafna.

First of all, evidence-based treatment guidelines. OK? We have never done this in dermatology before, and GRAPPA has certainly done this when it comes to some of the other committees that they have developed in rheumatology. So, can we create treatment guidelines that are evidencebased? There is very little in the literature. I know Chris Griffiths did an exhaustive review last year with his group on evidence-based and relating to psoriasis outcomes, but with no noise out there with methotrexate, cyclosporin, a little bit of noise out there with the retinoids, it has really been the biologic companies, some of whom are represented today, who have kind of driven this awareness that we in dermatology need to look at different evidence-based outcome measures and guidelines for treatment. And we have been pushed to do this by third-party payers as well. Seldom a day goes by where some of us, all of us involved in the trenches of psoriasis, are not asked to justify a $25,000 treatment and we do not have good literature to send these people. So I think that is one of the first ones I am going to throw out, which is treatment guidelines that are evidence-based.
The other one, the next one, which we have discussed at great length, are skin assessment tools.
All of you in industry, when you come together to create your clinical research studies, look at this PASI score, look at body surface area involvement, look at quality-of-life issues,
DLQI, you guys have HAQ scores—so how do we come up, or is there a way, that we can come up with skin assessment tools—and I think Phil touched a little bit on his discussion—that are more likely to bear fruit in the years ahead than what we currently have. And is there a better skin assessment tool out there that combines quality-of-life—we don’t have an ACR20 in dermatology; we have different DLQI scores, different indices, different sore
, etc. but we don’t have a unified assessment tool that can assess psoriasis as a whole, quality-of-life, and skin in combination. So that is the second aspect that I think we need to discuss. So, it’s instruments, quality-of-life, and skin assessment tools as one big broad group.
So I would like to kind of throw those two committees out first as two options for us to discuss, one, treatment guidelines, evidence-based treatment guidelines, and two, skin assessment tools that bring up different instruments and quality-of-life data as well.
HENNING BOEHNCKE : Can I comment on the status of in dermatology?
Because I don’t really agree. Number one, I understood that this is exactly what GRAPPA tries to come up with. This will be evidence-based guidelines, nothing else but evidence-based guidelines. With regard to psoriasis in a narrower sense from a dermatologist’s point of view, there are guidelines out there that are evidence-based. And maybe they are not good enough. The question is, if you are serious about evidence-based guidelines, this is a titanic task. And therefore, I’m sure you are aware of, the German dermatology association really has generated its own institute for that. We have an institute for evidence-based medicine in dermatology that is
guidelines, so that is headed by Professor Johnnie, and we are about to generate an basically the goal—
End of tape