Utilization Review Policy
Subject:
infliximab for IV injection (Remicade®)
Date revised: 12/09/2009, selected revision 01/13/2010
Description
Infliximab is a tumor necrosis factor (TNF) antagonist that is approved by the Food and Drug
Administration (FDA) for the following indications.
Rheumatoid arthritis in combination with methotrexate
Psoriatic arthritis
Ankylosing spondylitis
Plaque psoriasis
Crohn’s disease or fistulizing Crohn’s disease
Ulcerative colitis
Remicade is available as a lyophilized powder and is given by IV infusion over at least 2 hours.
It is available as 100 mg of infliximab in a 20 mL vial. After reconstitution, the product must be
further diluted to 250 mL with 0.9% sodium chloride injection. Premedication with
antihistamines, acetaminophen, or corticosteroids may be required to prevent adverse effects
during the infusion.
Indications, Medically Necessary
1. RA in adults: Indicated for the treatment of moderate to severe active RA in patients
who meet all of the following criteria.

Infliximab is prescribed by a rheumatologist, and

Patient has had an inadequate response to at least 2 months of therapy with one of the
following non-biologic DMARDs:
methotrexate, hydroxychloroquine, leflunomide
®
(Arava ), or sulfasalazine, and
Exceptions to having tried a non-biologic DMARD for 2 months can be made in the
following circumstances:
The patient could not tolerate the non-biologic DMARDs or if there are
contraindications to all four of these agents
OR
The patient has recent onset RA within the previous 6 months AND
infliximab will be given in combination with methotrexate unless there is a
contraindication to methotrexate AND
the patient has high disease activity as determined by the physician (document
physician’s method for determining disease activity) or has a poor prognosis.
Markers of poor prognosis include functional limitations based on the Health
Assessment Questionnaire (HAQ) score or other functional status measures; extraarticular manifestations of the disease (e.g., rheumatoid nodules, RA vasculitis,
secondary Sjögren’s syndrome, Felty’s syndrome, RA lung disease); positive
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Infliximab (Remicade)
rheumatoid factor (RF) and/or positive anti-citrullinated peptide (CCP) antibodies;
and/or bone/joint erosions by radiography. Patients with early RA and low or
moderate disease activity are usually not started on infliximab or another biologic
DMARD as the initial therapy.
Note: these patients should have tried a self-administered TNF antagonist before
infliximab. See next criteria.

Patient has tried a self-administered TNF antagonist, adalimumab (Humira), certolizumab
pegol (Cimzia), etanercept (Enbrel), or golimumab (Simponi) for at least 2 months and had
an inadequate response or was intolerant to one of these other TNF antagonists, and

Infliximab will be used in combination with methotrexate.
Infliximab is usually given in combination with methotrexate, but it has also been used in
combination with leflunomide or other oral DMARDs in patient who have
contraindications to or intolerant to methotrexate. Infliximab has also been used as
monotherapy for RA.
For patients who are continuing with infliximab there must be documentation that the patient
is or is not on another DMARD in conjunction with infliximab and the other drug therapies
that have been used to treat RA.
Dosing in RA: 3 mg/kg IV infusion followed by additional similar doses at 2 and 6 weeks
after the first infusion, then every 8 weeks thereafter. Should be given in combination with
MTX if possible. If the patient has an inadequate response to 3 mg/kg, the dose can be
increased gradually up to a maximum of 10 mg/kg. In patients who lose response before the
next dose is scheduled, the interval can be decreased to every 7, 6, 5, or 4 weeks or the dose
per infusion may be increased. The maximum dose is 10 mg/kg and the shortest interval is
every 4 weeks. Background: Many studies have shown that most patients with RA who
respond to infliximab will respond to the 3 mg/kg every 8 weeks dosage. Increasing the dose
and/or reducing the interval between infusions may increase the percentage of patients who
will respond.
Initial approval/extended approval: Initial approval is for 2 months of therapy. This is
3 mg/kg initially and then 2 and 6 weeks after the initial dose. Patients are evaluated for
response after the third dose. Approve for an additional 12 months of therapy if the patient
has responded (less joint pain, morning stiffness, or fatigue; improved function or activities
of daily living; decreased soft tissue swelling in joints or tendon sheaths; improved
laboratory values; reduced dosage of corticosteroids) as determined by the prescribing
rheumatologist. The patient may not have a full response by 2 months, but there should be
some response. If the response is inadequate after 4 doses, the dose can be increased
gradually up to 10 mg/kg or a lesser dose can be given at a more frequent interval. The dose
may need to be increased in patients whose disease flares after an initial response indicating a
loss of response to the drug.
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Infliximab (Remicade)
Duration of therapy in RA: indefinite if the patient is responding. Intermittent therapy has
been used but it is well accepted that therapy should be continuous in patients who respond.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. The initial dose in RA is
3 mg/kg. For patients who are already on infliximab, the dose should be calculated and the
number of vials needed assessed. Usually the dose should be rounded to the next whole
number of vials to avoid wasting unused medication left in the vial.
Dose 3 mg/kg
Body weight less than 70 kg
Body weight 70 to 100 kg
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Dose 6 mg/kg
Body weight 50 kg or less
Body weight 51 to 67 kg
Body weight 68 to 84 kg
Body weight 85 to 100 kg
Dose 7.5 mg/kg
54 kg or less
55 to 67 kg
68 to 80 kg
81 to 94 kg
95 to 108 kg
Dose 10 mg/kg
50 kg or less
52 to 60 kg
61 to 71 kg
72 to 81 kg
82 to 91 kg
92 to 100 kg
Number of vials
2
3
3
4
5
3
4
5
6
4
5
6
7
8
5
6
7
8
9
10
Exclusions: same for all indications. See below.
2. Psoriatic arthritis in adults: Indicated for moderately to severely active psoriatic
arthritis in patients who meet all of the following criteria.

Infliximab is prescribed by a rheumatologist or by a dermatologist in consultation with a
rheumatologist and
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Infliximab (Remicade)

Patients with peripheral arthritis, as the principle manifestation of psoriatic arthritis, have
had an inadequate response to at least 2 months of therapy with one of the following nonbiologic DMARDs or were intolerant to one of these agents: cyclosporine, leflunomide,
sulfasalazine, or methotrexate.
Exceptions to trying a non-biologic DMARD can be made for patients with peripheral
arthritis who have a poor prognosis as determined by the prescribing rheumatologist or
dermatologist. Factors associated with poor prognosis in psoriatic arthritis include the
number of actively inflamed joints (polyarticular disease rather than monoarticular
disease); elevated erythrocyte sedimentation rate; failure of other medications; presence
of damage on x-ray or clinically; loss of function; and diminished quality of life.
OR
Patients with moderate or severe axial manifestations of psoriatic arthritis should have had an
inadequate response to therapy with 2 different oral nonsteroidal anti-inflammatory drugs
(NSAID) that have been tried in about 1 month (for example, try one NSAID for 10 to 14
days and try a second for 10 to 14 days). Some examples of NSAIDs are naproxen,
diclofenac, ibuprofen, ketoprofen, oxaprozin, piroxicam.
OR
Patients with psoriatic arthritis with manifestations as enthesitis or dactylitis should have
tried a NSAID or a non-biologic DMARD (cyclosporine, leflunomide, sulfasalazine, or
methotrexate) for at least 2 months and had an inadequate response,
AND

Patient has tried a self-administered TNF antagonist, adalimumab (Humira), etanercept
(Enbrel), or golimumab (Simponi) for at least 2 months and had an inadequate response or
was intolerant to one of these other TNF antagonists.
For patients who are continuing with infliximab there must be documentation of the other
drug therapies that the patient has used to treat psoriatic arthritis.
Dosing in psoriatic arthritis: 5 mg/kg followed with additional similar doses at 2 and 6
weeks after the first infusion and then every 8 weeks thereafter. Other dosing regimens are
not FDA-approved for psoriatic arthritis. However, if the patient has an inadequate response
to 5 mg/kg, the dose can be increased gradually to a maximum of 10 mg/kg. In patients who
lose response before the next dose is scheduled, the interval can be decreased to every 7, 6, 5,
or 4 weeks. The maximum dose is 10 mg/kg and the shortest interval is every 4 weeks.
Initial approval/extended approval: Initial approval is for 2 months of therapy. This is
5 mg/kg initially and then 2 and 6 weeks after the initial dose. Patients are evaluated for
response after the third dose. Approve for an additional 12 months of therapy if the patient
has responded (less joint pain, morning stiffness, or fatigue; improved function or activities
of daily living; decreased soft tissue swelling in joints or tendon sheaths; improvements in
acute phase reactants [for example C-reactive protein]) as determined by the prescribing
rheumatologist or dermatologist. The patient may not have a full response by 2 months, but
there should be some response. If the response is inadequate after 4 doses, the dose can be
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Infliximab (Remicade)
increased up to 10 mg/kg or a lesser dose can be given at a shorter interval. Usually the
interval between doses is decreased and/or the dose is increased in increments up to
10 mg/kg. The dose may need to be increased in patient whose disease flares after an initial
response.
Duration of therapy in psoriatic arthritis: indefinite if the patient is responding. It is well
accepted that therapy should be continuous in patients who respond.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
3. Ankylosing spondylitis in adults: Indicated in patients with active ankylosing
spondylitis who meet all of the following criteria:

Infliximab is prescribed by a rheumatologist, and

Patient has had an inadequate response to at least 2 months of therapy with one non-biologic
DMARD such as sulfasalazine or methotrexate (see DMARD table) or was intolerant to one
of these agents, and
Exceptions can be made for patients with only axial disease. These patients should have
had an inadequate response to therapy with 2 different oral nonsteroidal antiinflammatory drugs (NSAID) that have been tried in about 1 month (for example, try one
NSAID for 10 to 14 days and try a second for 10 to 14 days). Some examples of
NSAIDs are naproxen, diclofenac, ibuprofen, ketoprofen, oxaprozin, piroxicam.

Patient has tried a self-administered TNF antagonist, adalimumab (Humira), etanercept
(Enbrel), or golimumab (Simponi) and had an inadequate response after at least 2 months of
therapy or was intolerant to one of these other TNF antagonists.
For patients who are continuing with infliximab there must be documentation of the other
drug therapies that the patient has used to treat ankylosing spondylitis.
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Infliximab (Remicade)
Dosing in ankylosing spondylitis: 5 mg/kg IV infusion followed by additional similar
doses at 2 and 6 weeks after the first infusion, and then every 6 weeks thereafter. Other
dosing regimens are not FDA-approved for ankylosing spondylitis. However, if the patient
has an inadequate response to 5 mg/kg, the dose can be increased to a maximum of
10 mg/kg. In patients who lose response before the next dose is scheduled, the interval can
be decreased to every 5 or 4 weeks. The maximum dose is 10 mg/kg and the shortest interval
is every 4 weeks.
Initial approval/extended approval: Initial approval is for 2 months of therapy. This is
5 mg/kg initially and then 2 and 6 weeks after the initial dose. Patients are evaluated for
response after the third dose. Approve for an additional 12 months of therapy if the patient
has responded (less joint pain, morning stiffness, or fatigue; improved mobility, e.g.,
improved spinal mobility; decreased soft tissue swelling in joints or tendon sheaths;
improvements in acute phase reactants (ESR, CRP) as determined by the prescribing
rheumatologist. The patient may not have a full response by 2 months, but there should be
some response. If the response is inadequate after 4 doses, the dose can be increased up to
10 mg/kg or a lesser dose can be given every 5 or 4 weeks. Usually the interval between
doses is decreased and/or the dose is increased in increments up to 10 mg/kg. The dose may
need to be increased in patient whose disease flares after an initial response.
Duration of therapy in ankylosing spondylitis: indefinite if the patient is responding. It is
well accepted that therapy should be continuous in patients who respond.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
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Infliximab (Remicade)
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
4. Plaque psoriasis in adults: Indicated for the treatment of severe chronic plaque
psoriasis in patients who meet all of the following criteria.

Infliximab is prescribed by a dermatologist, and

Patient has a minimum body surface area (BSA) involvement with plaque psoriasis of at least
5%, and
Exceptions to having a minimum BSA involvement can be made in the following
circumstances:
1) Patients with plaque psoriasis of the palms, soles, head and neck, nails, intertriginous
areas (inverse psoriasis), or genitalia are not required to have a minimum BSA
involvement
OR
2) Patients has had an inadequate response to a 3-month trial of either topical therapy
OR localized phototherapy AND an inadequate response to a 3-month trial of a
systemic therapy [methotrexate, acitretin (Soriatane), or cyclosporine] AND has
significant disability or impairment in physical or mental functioning, according to
the treating physician. Note: These patients are not required to meet the criteria in
the next bullet point.

Patient has tried systemic therapy with methotrexate, acitretin (Soriatane), or cyclosporine or
phototherapy with UVB or oral methoxsalen plus UVA light [PUVA]) for psoriasis for at
least 3 month, and
Exceptions can be made for patients who have contraindications to all of these therapies
and if phototherapy is not available.

Patient has tried a self-administered TNF antagonist, adalimumab (Humira) or etanercept
(Enbrel), for plaque psoriasis for at least 2 months and had an inadequate response or was
intolerant to one of these other TNF antagonists.
For patients who are continuing with infliximab there must be documentation of the other
drug therapies that the patient has used to treat plaque psoriasis.
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Infliximab (Remicade)
Dosing in plaque psoriasis in adults: 5 mg/kg followed with additional similar doses at
2 and 6 weeks after the first infusion and then every 8 weeks thereafter. Other dosing
regimens are not FDA-approved. However, if the patient has an inadequate response to
5 mg/kg, the dose can be increased to a maximum of 10 mg/kg. In patients who lose
response before the next dose is scheduled, the interval can be decreased to every 6, 5, or 4
weeks. The maximum dose is 10 mg/kg and the shortest interval is every 4 weeks.
Initial approval/extended approval: Initial approval is for 2 months of therapy. This is
5 mg/kg initially and then 2 and 6 weeks after the initial dose. Patients are evaluated for
response after the third dose. Approve for an additional 12 months of therapy if the patient
has responded (for example, there is less induration, erythema, scaling, itching) as
determined by the prescribing dermatologist. The patient may not have a full response by
2 months, but there should be some response. In clinical trials, patients were significantly
improved by week 10 of therapy. If the response is inadequate after 4 doses, the dose can be
increased up to 10 mg/kg and/or the interval decreased to every 6, 5, or 4 weeks.
Duration of therapy in plaque psoriasis: indefinite. It is well accepted that therapy should
be continuous in patients who respond.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. The initial dose in plaque
psoriasis is 5 mg/kg. For patients who are already on infliximab, the dose should be
calculated and the number of vials needed assessed. Usually the dose should be rounded to
the next whole number of vials to avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
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Infliximab (Remicade)
Crohn’s disease is divided into induction of remission, maintenance of remission, fistulizing
Crohn’s disease and to prevent recurrence of Crohn’s disease after ileocolonic resection.
5A. Crohn’s disease in adults and children aged 6 years and older (to induce
remission): Indicated in moderate to severe active Crohn’s disease in patients who meet all
of the following criteria.

Infliximab is prescribed by a gastroenterologist, and

Patient has had an inadequate response to treatment with corticosteroids (systemic),
azathioprine, 6-mercaptopurine, or methotrexate and
Exceptions to having an inadequate response to these other treatments can be made in one
of the following circumstances:
 Patient has been recently hospitalized for Crohn’s disease and was started on
infliximab in the hospital OR
 Patient has been started on azathioprine, 6-mercaptopurine or methotrexate and a
more rapid response is needed than can be provided by these other drugs OR Note:
these patients are still required to try a self-administered TNF antagonist, see next
criteria.
 If steroids are contraindicated or not desired, then azathioprine, 6-mercaptopurine, or
methotrexate should be tried if they are not contraindicated.

Patient has tried a self-administered TNF antagonist, adalimumab (Humira) or certolizumab
pegol (Cimzia) for at least 2 months and had an inadequate response or was intolerant to the
other TNF antagonist.
Exceptions to trying a self-administered TNF antagonist can be made in the following
circumstances:
 Patients who were recently hospitalized for Crohn’s disease and started infliximab in
the hospital OR
 Children or adolescents less than 18 years of age. Adalimumab and certolizumab
pegol are not FDA approved in children or adolescents with Crohn’s disease.
See criteria below for Dosing, Initial Approval/Extended Approval, Duration of
Therapy, Lab/Diagnostics Required, Waste Management, and Exclusions.
5B. Crohn’s disease in adults and children (to maintain remission): Indicated in
moderate to severe active Crohn’s disease for maintenance of remission in patients who meet
the following criteria.

Infliximab is prescribed by a gastroenterologist and

Patient has had induction therapy with infliximab and has responded with a lessening in
severity of signs and symptoms.
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Infliximab (Remicade)
See criteria below for Dosing, Initial Approval/Extended Approval, Duration of
Therapy, Lab/Diagnostics Required, Waste Management, and Exclusions.
5C. Fistulizing Crohn’s disease in adults: Indicated to reduce the number of draining
enterocutaneous (perianal or abdominal) and rectovaginal fistulas and maintaining fistula
closure in patients with Crohn’s disease who meet the following criteria.

Infliximab is prescribed by a gastroenterologist, and

Patient has enterocutaneous (perianal or abdominal) and/or rectovaginal fistulas, and

Patient has not responded to conventional treatment such as antibiotics (metronidazole
[Flagyl], ciprofloxacin [Cipro]), surgical drainage with examination under anesthesia, and/or
immunosuppressive therapy (azathioprine, 6-mercaptopurine, IV cyclosporine).
See criteria below for Dosing, Initial Approval/Extended Approval, Duration of
Therapy, Lab/Diagnostics Required, Waste Management, and Exclusions.
5D. Crohn’s disease in adults after ileocolonic resections: Indicated to reduce the chance
of recurrence after surgery in patients with Crohn’s disease who meet the following criteria.

Infliximab is prescribed by a gastroenterologist.
See criteria below for Dosing, Initial Approval/Extended Approval, Duration of
Therapy, Lab/Diagnostics Required, Waste Management, and Exclusions.
Dosing in active Crohn’s disease (5A,5B) or in fistulizing Crohn’s disease in adults
(5C): 5 mg/kg as an induction regimen at 0, 2, and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 8 weeks thereafter. If the patient has an inadequate response to 5
mg/kg, the dose can be increased gradually up to a maximum of 10 mg/kg. In patients who
lose response before the next dose is scheduled, the interval can be decreased to every 7, 6, 5,
or 4 weeks or the dose per infusion can be increased. The maximum dose is 10 mg/kg and
the shortest interval is every 4 weeks. Patients who do not respond by week 14 are unlikely
to respond with continued dosing and consideration should be given to discontinuing.
Dosing in active Crohn’s disease in children (5A,5B): 5 mg/kg given as an IV induction
regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
If the patient has an inadequate response to 5 mg/kg, the dose can be increased gradually up
to a maximum of 10 mg/kg. In patients who lose response before the next dose is scheduled,
the interval can be decreased to every 7, 6, 5, or 4 weeks or the dose per infusion can be
increased. The maximum dose is 10 mg/kg and the shortest interval is every 4 weeks.
Patients who do not respond by week 14 are unlikely to respond with continued dosing and
consideration should be given to discontinuing.
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Infliximab (Remicade)
Dosing in Crohn’s disease in adults after ileocolonic resections (5D): 5 mg/kg as an
induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every
8 weeks thereafter.
Initial approval/extended approval: For inducing remission in active Crohn’s disease in
adults and children and in adults with fistulizing Crohn’s disease, initial approval is for
3 doses of infliximab given at weeks 0, 2 and 6. Patients are evaluated for response after the
first 3 doses, about week 14, and for further maintenance therapy. If patients do not respond
to the 3 infusions, further treatment with infliximab is not recommended. Approve for an
additional 12 months of therapy if the patient has responded as determined by the prescribing
gastroenterologist. The patient may not have a full response after 3 doses, but there should
be some response. If the response is inadequate the dose can be gradually increased up to
10 mg/kg or a lesser dose can be given at a more frequent interval. For patients who respond
and then lose response, the dose may be increased to 10 mg/kg every 8 weeks or 5 mg/kg can
be given every 6, 5, or 4 weeks. The maximum dose is 10 mg/kg and the shortest interval is
every 4 hours.
To prevent recurrence of Crohn’s disease in adults after ileocolonic resections, approve for
12 months of therapy.
Duration of therapy in Crohn’s disease or fistulizing Crohn’s disease or after
ileocolonic resection: indefinite if the patient is responding. It is well accepted that
maintenance therapy is indicated if there is a response to induction therapy.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
6. Ulcerative colitis in adults: Indicated in moderately to severely active ulcerative colitis
in adult patients who meet all of the following criteria.

Infliximab is prescribed by a gastroenterologist, and
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Infliximab (Remicade)

Patient has had an inadequate response to treatment with a systemic corticosteroid (e.g.,
prednisone, methylprednisolone), azathioprine, 6-mercaptopurine, cyclosporine, or
tacrolimus (Prograf) for at least 2 months.
Dosing in ulcerative colitis in adults: 5 mg/kg as an IV infusion followed with additional
similar doses at 2 and 6 weeks after the first infusion and then every 8 weeks thereafter. If
the patient has an inadequate response to 5 mg/kg, the dose can be increased gradually up to
a maximum of 10 mg/kg. In patients who lose response before the next dose is scheduled,
the interval can be decreased to every 7, 6, 5, or 4 weeks or the dose per infusion can be
increased. The maximum dose is 10 mg/kg and the shortest interval is every 4 weeks.
Initial approval/extended approval: For induction therapy in active ulcerative colitis,
initial approval is for 3 doses of infliximab given at weeks 0, 2 and 6. Patients are evaluated
for response after the first 3 doses, about week 14, and for further maintenance therapy. If
patients do not respond to the 3 infusions, further treatment with infliximab is not
recommended. Approve for an additional 12 months of therapy if the patient has responded
as determined by the prescribing gastroenterologist. The patient may not have a full response
after 3 doses, but there should be some response. If the response is inadequate the dose can
be gradually increased up to 10 mg/kg or a lesser dose can be given at a more frequent
interval.
Duration of therapy in ulcerative colitis: indefinite if the patient is responding. It is well
accepted that maintenance therapy is indicated if there is a response to induction therapy.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. . See below.
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Infliximab (Remicade)
7. Juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA),
polyarticular course (regardless of type of onset). Indicated for the treatment of
polyarticular course JIA or JRA in patients who meet all of the following criteria. [NOT
FDA-APPROVED INDICATION]

Infliximab is prescribed by a rheumatologist, and

Patient has had an inadequate response to at least 2 months of therapy with methotrexate and
Exceptions to having tried methotrexate can be made in the following circumstances:
Infliximab will be given in combination with methotrexate or
Patient has an absolute contraindication to MTX (e.g., pregnancy, breast feeding,
alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias).

Patient has tried adalimumab (Humira) or etanercept (Enbrel) and had an inadequate
response after at least 2 months of therapy or was intolerant to one of these other TNF
antagonists.
Note: adalimumab and etanercept are FDA approved in the treatment of JIA.
Dosing in JIA/JRA: 3 to 6 mg/kg IV infusion followed by additional similar doses at 2 and
6 weeks after the first infusion, then every 8 weeks thereafter. The maximum maintenance
dose is 10 mg/kg/infusion. Infliximab is FDA approved for the treatment of Crohn’s disease
in children. The recommended dose in children with Crohn’s disease is 5 mg/kg given as an
IV induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg
every 8 weeks. Other dosing regimens are not FDA approved in Crohn’s disease in children.
Initial approval/extended approval: Initial approval is for 3 doses which is usually for
doses at weeks 0, 2, and 6. Patients are evaluated for response after the third dose, at about
week 12, and for further maintenance therapy. After 3 doses, approve for an additional
12 months of therapy if the patient has responded (e.g., has improvement in limitation of
motion; less joint pain or tenderness; decreased duration of morning stiffness or fatique;
improved function or activities of daily living; reduced dosage of corticosteroids), as
determined by the prescribing rheumatologist. The patient may not have a full response by
about week 12, but there should be some response.
Duration of therapy in JIA/JRA: indefinite in patients who are responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), and/or chest x-ray. In general, patients with latent TB infection should begin
preventive therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. The initial dose in
JIA/JRA is 3 to 6 mg/kg. For patients who are already on infliximab, the dose should be
12/09/2009
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Infliximab (Remicade)
calculated and the number of vials needed assessed. Usually the dose should be rounded to
the next whole number of vials to avoid wasting unused medication left in the vial.
Dose 3 mg/kg
Body weight less than 70 kg
Body weight 70 to 100 kg
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Dose 6 mg/kg
Body weight 50 kg or less
Body weight 51 to 67 kg
Body weight 68 to 84 kg
Body weight 85 to 100 kg
Number of vials
2
3
3
4
5
3
4
5
6
Exclusions: same for all indications. See below.
8. Undifferentiated spondyloarthropathy/spondyloarthritis in adults: Indicated for the
treatment of undifferentiated spondyloarthropathy/spondyloarthritis in patients who meet all
of the following criteria. [NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a rheumatologist, and

Patient has had an inadequate response to therapy with 2 different oral nonsteroidal antiinflammatory drugs (NSAID) that have been tried in about 1 month (for example, try one
NSAID for 10 to 14 days and try a second for 10 to 14 days). Some examples of NSAIDs
are naproxen, diclofenac, ibuprofen, ketoprofen, oxaprozin, piroxicam.

Patient has tried a self-administered TNF antagonist, etanercept (Enbrel) or adalimumab
(Humira) and had an inadequate response after at least 2 months of therapy or was intolerant
to one of these other TNF antagonists.
Dosing in undifferentiated spondyloarthropathy/spondyloarthritis: 5 mg/kg IV infusion
followed by additional similar doses at 2 and 6 weeks after the first infusion, then every
8 weeks thereafter.
Initial approval/extended approval: Initial approval is for 3 doses which is usually for
doses at weeks 0, 2, and 6. Patients are evaluated for response after the third dose, at about
week 12, and for further maintenance therapy. If patients do not respond to the 3 infusions,
further treatment with infliximab is not recommended. Approve for an additional 12 months
of therapy if the patient has responded as determined by the prescribing rheumatologist. The
patient may not have a full response by about week 12, but there should be some response.
Duration of therapy in undifferentiated spondyloarthropathy/spondyloarthritis:
indefinite if the patient is responding.
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Infliximab (Remicade)
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who are
already on infliximab, the dose should be calculated and the number of vials needed assessed.
Usually the dose should be rounded to the next whole number of vials to avoid wasting
unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
9. Still’s disease in adults (systemic-onset RA in adults, the disease may have begun in
childhood): Indicated for the treatment of Still’s disease in patients who meet all of the
following criteria. [NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a rheumatologist, and

Patient has tried a corticosteroid (e.g., prednisone, methylprednisolone) and has had an
inadequate response to one non-biologic DMARD such as methotrexate (see DMARD table)
given for at least 2 months or was intolerant to a non-biologic DMARD.
Dosing in Still’s disease: 3 to 5 mg/kg IV infusion followed by additional similar doses at
2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Initial approval/extended approval: Initial approval is for 3 doses which is usually for
doses at weeks 0, 2, and 6. Patients are evaluated for response after the third dose, at about
week 12, and for further maintenance therapy. If patients do not respond to the 3 infusions,
further treatment with infliximab is not recommended. Approve for an additional 12 months
of therapy if the patient has responded as determined by the prescribing rheumatologist. The
patient may not have a full response by about week 12, but there should be some response.
Duration of therapy in Still’s disease: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
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Infliximab (Remicade)
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who are
already on infliximab, the dose should be calculated and the number of vials needed assessed.
Usually the dose should be rounded to the next whole number of vials to avoid wasting
unused medication left in the vial.
Dose 3 mg/kg
Body weight less than 70 kg
Body weight 70 to 100 kg
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
2
3
3
4
5
Exclusions: same for all indications. See below.
10. SAPHO (synovitis, acne, pustulosis, hyperostosis, osteotis) syndrome in adults:
Indicated for the treatment of SAPHO in patients who meet all of the following criteria.
[NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a rheumatologist, and

Patient has had an inadequate response to an NSAID and at least one of the following:
methotrexate, a systemic corticosteroid, sulfasalazine, or cyclosporine.
Some examples of NSAIDs are naproxen, diclofenac, ibuprofen, ketoprofen, oxaprozin,
piroxicam (see NSAID table).
Dosing in SAPHO: 3 to 5 mg/kg IV infusion followed by additional similar doses at 2 and 6
weeks after the first infusion, then every 6 weeks thereafter.
Initial approval/extended approval: Initial approval is for 3 doses which is usually for
doses at weeks 0, 2, and 6. Patients are evaluated for response after the third dose, at about
week 12, and for further maintenance therapy. If patients do not respond to the 3 infusions,
further treatment with infliximab is not recommended. Approve for an additional 12 months
of therapy if the patient has responded (such as improvement of chest pain, bone pain, skin
lesions or other symptoms) as determined by the prescribing rheumatologist. The patient
may not have a full response by about week 12, but there should be some response.
Duration of therapy in SAPHO: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
12/09/2009
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Infliximab (Remicade)
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who are
already on infliximab, the dose should be calculated and the number of vials needed assessed.
Usually the dose should be rounded to the next whole number of vials to avoid wasting
unused medication left in the vial.
Dose 3 mg/kg
Body weight less than 70 kg
Body weight 70 to 100 kg
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
2
3
3
4
5
Exclusions: same for all indications. See below.
11. Indeterminate colitis in adults: Indicated in refractory indeterminate colitis in adults
who meet all of the following criteria. (Indeterminate colitis is defined as colitis that cannot
be classified with certainty as either ulcerative colitis or Crohn’s disease). [NOT FDAAPPROVED INDICATION]

Infliximab is prescribed by a gastroenterologist and

Patient has tried a systemic corticosteroid and has had an inadequate response to mesalamine
(e.g., Asacol, Pentasa, Lialda, Apriso) AND azathioprine or 6-mercaptopurine.
Dosing in indeterminate colitis in adults: 5 mg/kg as an IV infusion followed with
additional similar doses at 2 and 6 weeks after the first infusion and then every 8 weeks
thereafter.
Initial approval/extended approval: Initial approval is for 4 doses which is usually for
doses at weeks 0, 2, 6 and 14. Patients are evaluated for response after the first 4 doses,
about week 20, and for further maintenance therapy. If patients do not respond to the
4 infusions, further treatment with infliximab is not recommended. Approve for an
additional 12 months of therapy if the patient has responded as determined by the prescribing
physician. The patient may not have a full response by about week 20 but there should be
some response. If the response is inadequate the dose can be gradually increased up to
10 mg/kg or a lesser dose can be given at a more frequent interval. The maximum dose is
10 mg/kg and the shortest interval is every 4 hours.
Duration of therapy in indeterminate colitis: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
12/09/2009
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Infliximab (Remicade)
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. . See below.
12. Pouchitis in adults: Indicated in patients with active disease and to maintain remission
in patients who meet all of the following criteria. [NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a gastroenterologist and

Patient has tried therapy with an antibiotic (metronidazole [Flagyl], ciprofloxacin), probiotic
(live microorganisms), corticosteroid enema (e.g., hydrocortisone [Cortifoam, Cortenema]),
or mesalamine (Rowasa) enema.
Dosing in pouchitis in adults: 5 mg/kg as an induction regimen at 0, 2, and 6 weeks
followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter.
Initial approval/extended approval: for inducing remission in active pouchitis, initial
approval is for 3 doses of infliximab given at weeks 0, 2 and 6. Patients are evaluated for
response after the first 3 doses, about week 14, and for further maintenance therapy. If
patients do not respond to the 3 infusions, further treatment with infliximab is not
recommended. Approve for an additional 12 months of therapy if the patient has responded
as determined by the prescribing gastroenterologist.
Duration of therapy in pouchitis: indefinite if the patient is responding. It is well accepted
that maintenance therapy is indicated if there is a response to induction therapy.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
12/09/2009
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Infliximab (Remicade)
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. . See below.
13. Pyoderma gangrenosum in adults: Indicated in refractory pyoderma gangrenosum in
adults who meet all of the following criteria. [NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a gastroenterologist, dermatologist, rheumatologist, or oncologist
and

Patient has had an inadequate response to treatment with a systemic corticosteroid (e.g.,
prednisone, methylprednisolone) or cyclosporine for at least 2 months.
Dosing in pyoderma gangrenosum in adults: 5 mg/kg as an IV infusion followed with
additional similar doses at 2 and 6 weeks after the first infusion and then every 8 weeks
thereafter.
Initial approval/extended approval: Initial approval is for 4 doses which is usually for
doses at weeks 0, 2, 6 and 14. Patients are evaluated for response after the first 4 doses,
about week 20, and for further maintenance therapy. If patients do not respond to the
4 infusions, further treatment with infliximab is not recommended. Approve for an
additional 12 months of therapy if the patient has responded as determined by the prescribing
gastroenterologist, dermatologist, rheumatologist, or oncologist. The patient may not have a
full response by about week 20 but there should be some response. If the response is
inadequate the dose can be gradually increased up to 10 mg/kg or a lesser dose can be given
at a more frequent interval. The maximum dose is 10 mg/kg and the shortest interval is every
4 hours.
Duration of therapy in pyoderma gangrenosum: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
12/09/2009
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Infliximab (Remicade)
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. . See below.
14. Enterovesical fistulas (bowel to bowel, bowel to bladder, bowel to urethra) in adults
with Crohn’s disease. Indicated in refractory enterovesical fistulas in adults with Crohn’s
disease who meet all of the following criteria. [NOT FDA-APPROVED INDICATION]

Infliximab is prescribed by a gastroenterologist and

Patient has had an inadequate response to treatment with azathioprine, 6-mercaptopurine,
mycophenolate mofetil (Cellcept), cyclosporine, or tacrolimus (Prograf).
Dosing in enterovesical fistulas in adults: 5 mg/kg as an IV infusion followed with
additional similar doses at 2 and 6 weeks after the first infusion and then every 8 weeks
thereafter.
Initial approval/extended approval: Initial approval is for 4 doses which is usually for
doses at weeks 0, 2, 6 and 14. Patients are evaluated for response after the first 4 doses,
about week 20, and for further maintenance therapy. If patients do not respond to the
4 infusions, further treatment with infliximab is not recommended. Approve for an
additional 12 months of therapy if the patient has responded as determined by the prescribing
physician. The patient may not have a full response by about week 20 but there should be
some response. If the response is inadequate the dose can be gradually increased up to
10 mg/kg or a lesser dose can be given at a more frequent interval. The maximum dose is
10 mg/kg and the shortest interval is every 4 hours.
Duration of therapy in enterovesical fistulas: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who have
already been started on infliximab, the dose should be calculated and the number of vials
12/09/2009
20
Infliximab (Remicade)
needed assessed. Usually the dose should be rounded to the next whole number of vials to
avoid wasting unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
Number of vials
3
4
5
Exclusions: same for all indications. See below.
15. Hidradenitis suppurativa: Indicated for the treatment of moderate to severe
hidradenitis suppurativa in patients who meet all of the following criteria. [NOT FDAAPPROVED INDICATION]

Infliximab is prescribed by a dermatologist, and

The patient is 16 years of age and older, and

Patient has had an inadequate response to at least one course of topical or systemic antibiotic
therapy, intralesional or oral corticosteroids, or isotretinoin and

Patient has tried a self-administered TNF antagonist, etanercept (Enbrel) or adalimumab
(Humira) for at least 2 months and had an inadequate response or was intolerant to one of
these other TNF antagonists.
Dosing in hidradenitis suppurativa: 5 mg/kg IV infusion followed by additional similar
doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Initial approval/extended approval: Initial approval is for 3 doses which is usually for
doses at weeks 0, 2, and 6. Patients are evaluated for response after the third dose, at about
week 12, and for further maintenance therapy. If patients do not respond to the 3 infusions,
further treatment with infliximab is not recommended. Approve for an additional 12 months
of therapy if the patient has responded as determined by the prescribing physician. The
patient may not have a full response by about week 12, but there should be some response.
Duration of therapy in RA: indefinite if the patient is responding.
Labs/Diagnostics required: Patient should be screened for latent tuberculosis (TB)
infection prior to starting therapy and then every year while on infliximab. Screening may
include any of the following: history, tuberculin skin testing, interferon gamma release assay
(IGRA), chest x-ray. In general, patients with latent TB infection should begin preventive
therapy before starting infliximab.
Waste management: There is no overfill in the infliximab vials. For patients who are
already on infliximab, the dose should be calculated and the number of vials needed assessed.
12/09/2009
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Infliximab (Remicade)
Usually the dose should be rounded to the next whole number of vials to avoid wasting
unused medication left in the vial.
Dose 5 mg/kg
Body weight 61 kg or less
Body weight 62 to 81 kg
Body weight 82 to 100 kg
3
4
5
Exclusions: same for all indications. See below.
Exclusions:
 Concomitant use with anakinra (Kineret), any other TNF antagonist (such as etanercept,
adalimumab, golimumab [Simponi], certolizumab pegol [Cimzia]), abatacept (Orencia),
rituximab (Rituxan), natalizumab (Tysabri), alefacept (Amevive), or ustekinumab
(Stelara).
 Doses > 5 mg/kg should not be administered in patients with congestive heart failure.
Contraindicated in patients with moderate or severe heart failure (New York Heart
Association class III-IV) with reduced ejection fraction.
 Intra-articular administration is not FDA approved.
 Infliximab is contraindicated in patients with significant active infections.
 Wegener’s granulomatosis.
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van der Heijde D, Kavanaugh A, Gladman DD, et al. Infliximab inhibits progression of radiographic damage in patients
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clinical trial 2. Arthritis Rheum. 2007;56:2698-2707.

Kavanaugh A, Antoni C, Krueger GG, et al. Infliximab improves health-related quality of life and physical function in
patients with psoriatic arthritis. Ann Rheum Dis. 2006;65:471-477.

Antoni CE, Kavanaugh A, Kirkham B, et al. Sustained benefits of infliximab therapy for dermatologic and articular
manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT).
Arthritis Rheum. 2005;52:1227-1236.

Kavanaugh A, Antoni CE, Gladman DD, et al. The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT):
Results of radiographic analyses after 1 year. Ann Rheum Dis. 2006;65:1038-1043.

Antoni CE, Kavanaugh A, van der Heijde D, et al. Two-year efficacy and safety of infliximab treatment in patients with
active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). J
Rheumatol. 2008;35:869-876.
Ankylosing Spondylitis
12/09/2009
23
Infliximab (Remicade)

Zochling J, van der Heijde D, Burgos-Vargas R, et al. ASAS/EULAR recommendations for the management of ankylosing
spondylitis. Ann Rheum Dis. 2006;65:442-452.

Zochling J, van der Heijde D, Dougados M, et al. Current evidence for the management of ankylosing spondylitis a
systematic literature review for the ASAS/EULAR management recommendations in ankylosing spondylitis. Ann Rheum
Dis. 2006;65:423-432.

Zochling J, Braun J. Quality indicators, guidelines and outcome measures in ankylosing spondylitis. Clin Exp Rheumatol.
2007;25(6 Suppl 47):147-152.

van der Heijde D, Landewé R, Baraliakos X, et al; Ankylosing Spondylitis Study for the Evaluation of Recombinant
Infliximab Therapy Study Group. Radiographic findings following two years of infliximab therapy in patients with
ankylosing spondylitis. Arthritis Rheum. 2008;58:3063-3070.

van der Heijde D, Dijkmans B, Geusens P, et al; Ankylosing Spondylitis Study for the Evaluation of Recombinant
Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a
randomized, placebo-controlled trial (ASSERT). Arthritis Rheum. 2005;52:582-591.

Braun J, Landewe R, Hermann KG, et al; ASSERT Study Group. Major reduction in spinal inflammation in patients with
ankylosing spondylitis after treatment with infliximab: results of a multicenter, randomized, double-blind, placebocontrolled magnetic resonance imaging study. Arthritis Rheum. 2006;54:1646-1652.

Braun J, Deodhar A, Dijkmans B, et al; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab
Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period.
Arthritis Rheum. 2008;59:1270-1278.

Braun J, Brandt J, Listing J, et al. Treatment of active ankylosing spondylitis with infliximab: a randomized controlled
multicentre trial. Lancet. 2002;359:1187-1193.

Braun J, Baraliakos X, Listing J, et al. Persistent clinical efficacy and safety of anti-tumour necrosis factor alpha therapy
with infliximab in patients with ankylosing spondylitis over 5 years: evidence for different types of response. Ann Rheum
Dis. 2008;67:340-345.

Breban M, Ravaud P, Claudepierre P, et al; French Ankylosing Spondylitis Infliximab Network. Maintenance of infliximab
treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus ondemand treatment. Arthritis Rheum. 2008;58:88-97.
Plaque Psoriasis

Kalb RE, Bagel J, Korman NJ, et al.; National Psoriasis Foundation. Treatment of intertriginous psoriasis: from the Medical
Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2009;60:120-124.

Callen JP, Krueger GG, Lebwohl M, et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol.
2003;49:897-899.

Pariser DM, Bagel J, Gelfand JM, et al; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on
disease severity. Arch Dermatol. 2007;143:239-242.

Menter A, Griffiths CEM. Current and future management of psoriasis. Lancet. 2007;370:272-284.

Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section
1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol.
2008;58:826-850.

Feldman SR, Koo JY, Menter A, et al. Decision points for the initiation of systemic treatment for psoriasis. J Am Acad
Dermatol. 2005;53:101-107.

Reich K, Nestle FO, Papp K, et al; EXPRESS study investigators. Infliximab induction and maintenance therapy for
moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366:1367-1374.

Reich K, Nestle FO, Papp K, et al. Improvement in quality of life with infliximab induction and maintenance therapy in
patients with moderate-to-severe psoriasis: a randomized controlled trial. Br J Dermatol. 2006;154:1161-1168.

Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab
maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol.
2007;56:31.e1-15.

Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized,
double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51:534-542.

Rich P, Griffiths CE, Reich K, et al. Baseline nail disease in patients with moderate to severe psoriasis and response to
treatment with infliximab during 1 year. J Am Acad Dermatol. 2008;58:224-231.

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section
3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol.
2009;60:643-659.

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section
4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol.
2009;61:451-485.

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis Section
5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2009
Oct 6. [Epub ahead of print]
Inflammatory Bowel Disease
12/09/2009
24
Infliximab (Remicade)



























Lichtenstein GR, Hanauer SB, Sandborn WJ; and The Practice Parameters Committee of the American College of
Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009;104:465-483.
Clark M, Colombel JF, Feagan BC, et al. American gastroenterological association consensus development conference on
the use of biologics in the treatment of inflammatory bowel disease, June 21-23, 2006. Gastroenterology. 2007;133:312339.
Lichtenstein GR, Abreu MT, Cohen R, et al; American Gastroenterological Association. American Gastroenterological
Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease.
Gastroenterology. 2006;130:940-987.
Lichtenstein GR, Abreu MT, Cohen R, et al; American Gastroenterological Association. American Gastroenterological
Association Institute medical position statement on corticosteroids, immunomodulators, and infliximab in inflammatory
bowel disease. Gastroenterology. 2006;130:935-939.
Sandborn WJ, Fazio VW, Feagan BG, et al; American Gastroenterological Association Clinical Practice Committee. AGA
technical review on perianal Crohn's disease. Gastroenterology. 2003;125:1508-1530.
Baumgart DC Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet.
2007;369:1641-1657.
Peyrin-Biroulet L, Deltenre P, de Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease:
meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6:644-653.
Parsi MA, Lashner BA, Achkar JP, et al. Type of fistula determines response to infliximab in patient with fistulous Crohn’s
disease. Am J Gastroenterol. 2004;99:445-449.
Barrie A, Regueiro M. Biologic therapy in the management of extraintestinal manifestations of inflammatory bowel
disease. Inflamm Bowel Dis. 2007;13:1424-1429.
Ferrante M, D'Haens G, Dewit O, et al; on behalf of the Belgian IBD Research Group. Efficacy of infliximab in refractory
pouchitis and Crohn's disease-related complications of the pouch: A Belgian case series. Inflamm Bowel Dis. 2009 Jul 27.
[Epub ahead of print]
Colombel JF, Ricart E, Loftus EV Jr, et al. Management of Crohn's disease of the ileoanal pouch with infliximab. Am J
Gastroenterol. 2003;98:2239-2244.
Viscido A, Habib FI, Kohn A, et al. Infliximab in refractory pouchitis complicated by fistulae following ileo-anal pouch for
ulcerative colitis. Aliment Pharmacol Ther. 2003;17:1263-1271.
Pardi DS, D’Haens G, Shen B, et al. Clinical guidelines for the management of pouchitis. Inflamm Bowel Dis.
2009;15;1424-1431/
Sandborn WJ, Rutgeerts P, Feagan BG, et al. Colectomy rate comparison after treatment of ulcerative colitis with placebo
or infliximab. Gastroenterology. 2009;137:1250-1260.
Gisbert JP, Panés J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J
Gastroenterol. 2009;104:760-767.
Regueiro M, Siemanowski B, Kip KE, Plevy S. Infliximab dose intensification in Crohn's disease. Inflamm Bowel Dis.
2007;13:1093-1099.
Magro F, Bastos R, Marques M, Costa Santos C. Infliximab dose intensification by shortening infusion intervals. Inflamm
Bowel Dis. 2008;14:432-434.
Lichtenstein GR, Diamond RH, Wagner CL, et al. Clinical trial: benefits and risks of immunomodulators and maintenance
infliximab for IBD-subgroup analyses across four randomized trials. Aliment Pharmacol Ther. 2009;30:210-226.
Hommes DQ. Risks and benefits of biologic therapy for IBD. J Pediatr Gastroenterol Nutr. 2009;48 Suppl 2:S52-S53. .
D'Haens G, Baert F, van Assche G, et al; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club.
Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an
open randomised trial. Lancet. 2008;371:660-667.
Lemann M, Mary JY, Duclos B, et al; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif
(GETAID). Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled
trial. Gastroenterology. 2006;130:1054-1061.
Stephens MC, Shepanski MA, Mamula P, et al. Safety and steroid-sparing experience using infliximab for Crohn’s disease
at a pediatric inflammatory bowel disease center. Am J Gastroenterol. 2003;98:104-111.
Van Assche G, Magdelaine-Beuzelin C, D'Haens G, et al. Withdrawal of immunosuppression in Crohn's disease treated
with scheduled infliximab maintenance: a randomized trial. Gastroenterology. 2008;134:1861-1868.
Akobeng AK. Review article: the evidence base for interventions used to maintain remission in Crohn's disease. Aliment
Pharmacol Ther. 2008;27:11-18.
McGinnis JK, Murray KF. Infliximab for ulcerative colitis in children and adolescents. J Clin Gastroenterol. 2008;42:875879.
Rutgeerts P, Sandborn WJ, Feagan BG, eta l. Infliximab for induction and maintenance therapy for ulcerative colitis. N
Engl J Med. 2005;353:2462-2476.
Jarnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a
randomized, placebo-controlled study. Gastroenterology. 2005;128:1805-1811.
12/09/2009
25
Infliximab (Remicade)

Feagan BG, Reinisch W, Rutgeerts P, ET AL. The effects of infliximab therapy on health-related quality of life in
ulcerative colitis patients. Am J Gastroenterol. 2007;102:794-802.

Fanjiang G, Russell GH, Katz AJ. Short- and long-term response to and weaning from infliximab therapy in pediatric
ulcerative colitis. J Pediatr Gastroenterol Nutr. 2007;44:312-317.
JIA OR JRA [NOT FDA-APPROVED INDICATION]

Lahdenne P, Vahasalo P, Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile
idiopathic arthritis: an open label study. Ann Rheum Dis. 2003;62:245-247.

Gerloni V, Pontikaki I, Gattinara M, et al. Efficacy of repeated intravenous infusions of an anti-tumor necrosis factor alpha
monoclonal antibody, infliximab, in persistently active, refractory juvenile idiopathic arthritis: results of an open-label
prospective study. Arthritis Rheum. 2005;52:548-553.

Ruperto N, Lovell DJ, Cuttica R, et al; Paediatric Rheumatology International Trials Organisation; Pediatric Rheumatology
Collaborative Study Group. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of
polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007;56:3096-3106.

Tse SM, Burgos-Vargas R, Laxer RM. Anti-tumor necrosis factor alpha blockade in the treatment of juvenile
spondylarthropathy. Arthritis Rheum. 2005;52:2103-2108.

Ruperto N, Lovell DJ, Cuttica R, et al. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of
polyarticular course juvenile rheumatoid arthritis: Findings from an open-label treatment extension. Ann Rheum Dis. 2009
Apr 29. [Epub ahead of print]
Undifferentiated spondyloarthropathy/spondyloarthritis [NOT FDA-APPROVED INDICATION]

Davis JC, Mease PJ. Insights into the pathology and treatment of spondyloarthritis: from the bench to the clinic. Semin
Arthritis Rheum. 2008;38:83-100.

Haibel H, Rudwaleit M, Listing J, et al. Efficacy of adalimumab in the treatment of axial spondylarthritis without
radiographically defined sacroiliitis: Results of a twelve-week randomized, double-blind, placebo-controlled trial followed
by an open-label extension up to week fifty-two. Arthritis Rheum. 2008;58:1981-1991.

Brandt J, Khariouzov A, Listing J, et al. Successful short term treatment of patients with severe undifferentiated spondyloarthritis with the anti-tumor necrosis factor-alpha fusion receptor protein etanercept. J Rheumatol. 2004;31:531-538.

Flagg SD, Meador R, Hsia E, et al. Decreased pain and synovial inflammation after etanercept therapy in patients with
reactive and undifferentiated arthritis: an open-label trial. Arthritis Rheum. 2005;53:613-617.

Van Den Bosch F, Kruithof E, Baeten D, et al. Randomized double-blind comparison of chimeric monoclonal antibody to
tumor necrosis factor alpha (infliximab) versus placebo in active spondyloarthropathy. Arthritis Rheum. 2002;46:755-765.

Brandt J, Haibel H, Reddig J, et al. Successful short term treatment of severe undifferentiated spondyloarthropathy with the
anti-tumor necrosis factor-alpha monoclonal antibody infliximab. J Rheumatol. 2002;29:118-122.
Still’s disease in adults [NOT FDA-APPROVED INDICATION]

Dilhuydy MS, Vatan R, Etienne G, et al. Prolonged efficacy of infliximab for refractory adult-onset Still’s disease. Clin
Exp Rheumatol. 2005;23:121-122.

Fautrel B, Sibilia J, Mariette X, et al. Tumour necrosis factor alpha blocking agents in refractory adult Still’s disease: an
observational study of 20 cases. Ann Rheum Dis. 2005;64:262-266.

Kokkinos A, Iliopoulos A, Greka P, et al. Successful treatment of refractory adult-onset Still’s disease with infliximab. A
prospective, non-comparative series of four patients. Clin Rheumatol. 2004;23:45-49.

Caramaschi P, Carletto A, Biasi D, Bambara LM. A case of adult onset Still’s disease treated with infliximab. Clin Exp
Rheumatol. 2002;20:113.

Kraetsch HG, Antoni C, Kalden JR, Manger B. Successful treatment of a small cohort of patients with adult onset Still’s
disease with infliximab: first experiences. Ann Rheum Dis. 2001;60 Suppl 3:iii55-iii57.

Cavagna L, Caporali R, Epis O, et al. Infliximab in the treatment of adult Still’s disease refractory to conventional therapy.
Clin Exp Rheumatol. 2001;19:329-332.

Kontzias A, Efthimiou P. Adult-onset Still's disease: pathogenesis, clinical manifestations and therapeutic advances.
Drugs. 2008;68:319-337.
SAPHO [NOT FDA-APPROVED INDICATION]

Moll C, Hernández MV, Cañete JD, et al. Ilium osteitis as the main manifestation of the SAPHO syndrome: response to
infliximab therapy and review of the literature. Semin Arthritis Rheum. 2008;37:299-306.
Indeterminate colitis [NOT FDA-APPROVED INDICATION]

Papadakis KA, Treyzon L, Abreu MT, et al. Infliximab in the treatment of medically refractory indeterminate colitis.
Aliment Pharmacol Ther. 2003;18:741-747.

Gornet JM, Couve S, Hassani Z, et al. Infliximab for refractory ulcerative colitis or indeterminate colitis: an open-label
multicentre study. Aliment Pharmacol Ther. 2003;18:175-181.

Bordeianou L, Kunitake H, Shellito P, Hodin R. Preoperative infliximab treatment in patients with ulcerative and
indeterminate colitis does not increase rate of conversion to emergent and multistep abdominal surgery. Int J Colorectal
Dis. 2009 Oct 2. [Epub ahead of print]
Pyoderma gangrenosum [NOT FDA-APPROVED INDICATION]

Reichrath J, Bens G, Bonowitz A, et al. Treatment recommendations for pyoderma gangrenosum: an evidence-based review
of the literature based on more than 350 patients. J Am Acad Dermatol. 2005;53:273-283.
12/09/2009
26
Infliximab (Remicade)

Regueiro M, Valentine J, Plevy S, et al. Infliximab for treatment of pyoderma gangrenosum associated with inflammatory
bowel disease. Am J Gastroenterol. 2003;98:1821-1826.

Brooklyn TN, Dunnill GS, Shetty A, et al. Infliximab for the treatment of pyoderma gangrenosum: a randomised, doubleblind placebo-controlled trial. Gut. 2006;55:505-509.

Juillerat P, Christen-Zäch S, Troillet FX, et al. Infliximab for the treatment of disseminated pyoderma gangrenosum
associated with ulcerative colitis. Case report and literature review. Dermatology. 2007;215:245-251.
Enterovesical fistulas [NOT FDA-APPROVED INDICATION]

Parsi MA, Lashner BA, Achkar JP, et al. Type of fistula determines response to infliximab in patients with fistulous Crohn's
disease. Am J Gastroenterol. 2004;99:445-449.
Hidradenitis suppurativa [NOT FDA-APPROVED INDICATION]

Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009;60:539-561.

ClinicalTrials.gov. Study to assess the safety and efficacy of infliximab to treat hidradenitis suppurtativa. Bethesda, MD:
U.S.
National
Institutes
of
Health;
November
21,
2008
(last
update).
Available
at:
http://clinicaltrials.gov/ct2/show/NCT00795574?term=hs2006&rank=1. Accessed on: November 17, 2009.

Adams DR, Gordon KB, Devenyi AG, et al. Severe hidradenitis suppurativa treated with infliximab infusion. Arch
Dermatol. 2003;139:1540-1542.

Mekkes JR, Bos JD. Long-term efficacy of a single course of infliximab in hidradenitis suppurativa. Br J Dermatol.
2008;158:370-374.

Moul DK, Korman NJ. The cutting edge. Severe hidradenitis suppurativa treated with adalimumab. Arch Dermatol.
2006;142:1110-1112.

Yamauchi PS, Mau N. Hidradenitis suppurativa managed with adalimumab. J Drugs Dermatol. 2009;8:181-183.

Blanco R, Martinex-Taboada VM, Villa I, et al. Long-term successful adalimumab therapy in severe hidradenitis
suppurativa. Arch Dermatol. 2009;145:580-584.

Cusack C, Buckley C. Etanercept: effective in the management of hidradenitis suppurativa. Br J Dermatol. 2006;154:726729.

Giamarellos-Bourboulis EJ, Pelekanou E, et al. An open-label phase II study of the safety and efficacy of etanercept for the
therapy of hidradenitis suppurativa. Br J Dermatol. 2008;158:567-572.

Lee RA, Dommasch E, Treat J, et al. A prospective clinical trial of open-label etanercept for the treatment of hidradenitis
suppurativa. J Am Acad Dermatol. 2009;60:565-573.
Ileocolonic resection

Regueiro M, Schraut W, Baidoo L, et al. Infliximab prevents Crohn's disease recurrence after ileal resection.
Gastroenterology. 2009;136:441-450.

Sorrentino D, Terrosu G, Avellini C, Maiero S. Infliximab with low-dose methotrexate for prevention of postsurgical
recurrence of ileocolonic Crohn disease. Arch Intern Med. 2007 10;167:1804-1807.

Yamamoto T, Umegae S, Matsumoto K. Impact of infliximab therapy after early endoscopic recurrence following
ileocolonic resection of Crohn's disease: A prospective pilot study. Inflamm Bowel Dis. 2009;15:1460-1466.
Familial Mediterranean Fever [NOT FDA-APPROVED INDICATION]

Nakamura A, Matsuda M, Tazawa K, et al. Successful treatment with infliximab and low-dose methotrexate in a Japanese
patient with familial Mediterranean fever. Intern Med. 2007;46:1247-1249.

Ozgocmen S, Ozçakar L, Ardicoglu O, et al. Familial Mediterranean fever responds well to infliximab: single case
experience. Clin Rheumatol. 2006;25:83-87.

Yüksel S, Yalçinkaya F, Acar B, et al. Clinical improvement with infliximab in a child with amyloidosis secondary to
familial Mediterranean fever. Rheumatology (Oxford). 2006;45:1307-1308.

Daysal S, Akcil G, Goker B, et al. Infliximab therapy in a patient with familial Mediterranean fever and chronic hip
arthritis. Arthritis Rheum. 2005;53:146-147.

Brik R, Gepstein V, Shahar E, et al. Tumor necrosis factor blockade in the management of children with orphan diseases.
Clin Rheumatol. 2007;26:1783-1785.
Amyloidosis with renal involvement in adults [NOT FDA-APPROVED INDICATION]

Keersmaekers T, Claes K, Kuypers DR, et al. Long-term efficacy of infliximab treatment for AA-amyloidosis secondary to
chronic inflammatory arthritis. Ann Rheum Dis. 2009;68:759-761.

Gottenberg JE, Merle-Vincent F, Bentaberry F, et al. Anti-tumor necrosis factor alpha therapy in fifteen patients with AA
amyloidosis secondary to inflammatory arthritides: a followup report of tolerability and efficacy. Arthritis Rheum.
2003;48:2019-2024.

Fernandez-Nebro A, Tomero E, Ortiz-Santamaria V, et al. Treatment of rheumatic inflammatory disease in 25 patients with
secondary amyloidosis using tumor necrosis factor alpha antagonists. Am J Med. 2005;118:552-556.
Abbreviations:
BSA = body surface area
anti-CCP antibodies = anti-citrullinated peptide antibodies
12/09/2009
27
Infliximab (Remicade)
CRP = C-reactive protein
DMARD = disease modifying antirheumatic drug
FDA = Food and Drug Administration
IGRA = interferon gamma release assay
IV = intravenous
mL = milliliter
NSAID = Nonsteroidal anti-inflammatory drug
TB = tuberculosis
TNF = tumor necrosis factor
Disease Modifying Antirheumatic Drugs (DMARDs).
Generic Name
Trade Name
Traditional (Synthetic) DMARDs
azathioprine (oral)
generics, Imuran
cyclosporine (oral)
generics, Neoral, Sandimmune
d-penicillamine (oral)
Cuprimine, Depen
gold compounds
gold sodium thiomalate (injection) Myochrysine®
auranofin (oral)
Ridaura
hydroxychloroquine (oral)
generics, Plaquenil
leflunomide (oral)
generics, Arava
methotrexate [MTX] (oral, injection)
generics, Rheumatrex
minocycline (oral)
generics, Minocin®
sulfasalazine (oral)
generics, Azulfidine En-tabs, Azulfidine
Biologic DMARDs
abatacept (injection)
Orencia
adalimumab (injection)
Humira
anakinra (injection)
Kineret
certolizumab pegol (injection)
Cimzia®
etanercept (injection)
Enbrel
golimumab (injection)
Simponi®
infliximab (injection)
Remicade
rituximab (injection)
Rituxan®
tocilizumab (injection)
Actemra®
12/09/2009
28
Infliximab (Remicade)
Nonsteroidal anti-inflammatory drugs (NSAIDs) list.
Generic name
Brand name examples
diclofenac epolamine topical patch
Flector® Patch
diclofenac potassium
Cataflam® , generics; Zipsor™
diclofenac sodium
Voltaren®, Voltaren XR®, generics
diclofenac sodium topical gel
Voltaren® Gel
diclofenac sodium and misoprostol tablets
Arthrotec
etodolac
Lodine®, Lodine XL®, generics
fenoprofen
Nalfon®, generics
flurbiprofen
Ansaid®, generics)
ibuprofen*
Motrin®, Advil®, generics
ibuprofen tablets and caffeine supplement capsules IC 400™ Kit, IC 800™ Kit
indomethacin
Indocin®, Indocin SR®, generics
ketoprofen
Orudis®, generics
ketoprofen sustained-release
Oruvail®, generics
ketorolac, tablets, injectable
Toradol®, generics
lansoprazole delayed-release capsules and
Prevacid® NapraPAC™ 500
naproxen tablets
meclofenamate
generics
mefenamic acid capsules
Ponstel, generics
meloxicam tablets
Mobic, generics
nabumetone
Relafen®, generics
naproxen
Naprosyn®, generics
naproxen delayed-release
Naprosyn EC®, generics
naproxen controlled-release
Naprelan®, generics
naproxen sodium*
Anaprox®, Anaprox DS®, generics
oxaprozin
Daypro®, generics
piroxicam
Feldene®, generics
sulindac
Clinoril®, generics
tolmetin
generics
*Available without a prescription.
12/09/2009
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