1
Allergic Rhinitis in the United
States Pediatric Population
EO Meltzer,1 MS Blaiss,2 MJ Derebery,3
TA Mahr,4 B Gordon,5 KK Sheth,6
AL Simmons,7 M Wingertzahn,8 JM
Boyle9
2
Patient Perspectives on the
Symptoms of Allergic Rhinitis and the
Effect of Allergic Rhinitis on Daily Living
Michael S. Blaiss,1 John M. Boyle,2 Judith Droar3
1University
of Tennessee Health Sciences Center, Memphis, TN;
2Schulman, Ronca and Bucuvalas, Inc., New York, NY;
3ALTANA Pharma US, Inc., Florham Park, NJ
3
Allergies in America
• Allergies in America: A Landmark Survey of
Nasal Allergy Sufferers is a comprehensive
survey of patient and healthcare-provider
perspectives on nasal allergies and their
treatment
– This presentation focuses on patients’ perceptions
of the symptoms of AR and the burden of AR on
patients’ daily lives
AR = Allergic rhinitis.
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
4
Methods
Allergies in America: A Landmark Survey of
Nasal Allergy Sufferers
• 31,470 households in the United States were screened to
obtain a national sample of nasal allergy sufferers
• A total of 2,500 adults (aged ≥ 18 years) were interviewed by
telephone about their condition and treatment
– Diagnosed with AR, nasal allergies, or “hay fever”
– Symptomatic
– Received treatment for their nasal allergies within the
previous 12 months
AR = Allergic rhinitis.
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
5
Methods (continued)
• Development of patient survey questionnaire
– No existing validated, standardized, AR questionnaire
– New patient questionnaire developed to collect accurate and
relevant information on AR
• Analysis of relevant literature
• Identification of questions used to study similar diseases
in accepted health surveys
– Key aspects of patient questionnaire
• AR symptoms
• Effect of AR on quality of life
• Nasal allergy medications, effectiveness, and side effects
– Draft questionnaire approved by a panel of AR experts
AR = Allergic rhinitis.
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
6
Nasal Allergy Symptoms in Patients With
Allergic Rhinitis
During the worst 1-month period in the past year, did you have (symptom) every
day, most days a week, a few days a week, a few days a month, less than that,
or never? N = 2,500
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
7
Common Nasal Allergy Symptoms Are
Bothersome
When you have nasal allergy attacks, how bothersome are the following
symptoms usually–extremely bothersome, moderately bothersome, slightly
bothersome, or not bothersome? N = 2,500
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
8
32% of Patients With Nasal Allergies Have
Comorbid Asthma
Past 12
months
20%
Never
68%
Not past
12 months
12%
Have you ever been diagnosed with asthma? Have you had asthma in the past
12 months? N = 2,500
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
9
Nasal Allergies Contribute to Absenteeism
and Interfere With Patient Performance at Work
Neither
48%
Interfered
only
22%
Missed work
only 10%
Both
20%
Have you missed work in the past 12 months due to your nasal allergies?
Aside from actually missing work, have your nasal allergy symptoms in the past
12 months interfered with your performance at work? Base: Employed full time.
N = 1,315
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
10
Mean productivity, %
When Nasal Allergy Symptoms Are at Their
Worst, Work Productivity Declines by 23%
Thinking about your productivity on a scale of 0 to 100, where 100 means 100%
productivity, where would you rank your productivity on days when you don’t
have nasal allergy symptoms?
Where would you rank your productivity on the same scale of 0 to 100 . . . when
your nasal allergies are at their worst? Base: Employed full time. N = 1,315
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
11
The Majority of Patients Believe That
Nasal Allergies Affect Daily Living
Little
19%
Didn’t really
impact
14%
Not sure
1%
A lot
15%
Some
26%
Moderate
amount
25%
During allergy season, would you say the condition impacted you daily life?
N = 2,500
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
12
64% of Patients Do Not Always Adhere to
Health Practitioner Advice
All of the time
36%
Not sure
1%
Never, 4%
Rarely, 4%
Most of the time
41%
Some of the
time
13%
Would you say that you follow your health practitioner’s advice on the
management and treatment of your nasal allergies—all of the time, most of the
time, some of the time, rarely, or never? N = 2,500
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
13
Conclusions
• Nasal allergy sufferers experience a range of symptoms
– Stuffed-up nose, post-nasal drip, repeated sneezing, and runny
nose are the most bothersome symptoms of nasal allergies
• Approximately one third of patients with nasal allergies also
suffer from asthma
• Nasal allergies negatively affect patients’ daily lives
– 52% of patients with AR are affected in their performance at
work
– Patients experience an average productivity loss of 23% when
symptoms are at their worst
• Only 36% of patients follow their healthcare practitioners’
advice all of the time
AR = Allergic rhinitis.
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. ALTANA Pharma US, Inc., 2006.
15
Allergic Rhinitis in the United
States Pediatric Population
EO Meltzer,1 MS Blaiss,2 MJ Derebery,3
TA Mahr,4 B Gordon,5 KK Sheth,6
AL Simmons,7 M Wingertzahn,8 JM
Boyle9
16
Pediatric Allergies in America
• This comprehensive survey was designed to use a credible
data-collection approach to determine the prevalence of allergic
rhinitis among children aged 4 to 17 in the US population
– Random-digit dialing using both geographic and US census
population estimates weights the sample to control for sample and
non-sample bias
• This study also collected information on what this condition
means to its sufferers in terms of diagnosis, management, and
treatment
• 35,757 households in the United States were screened to obtain
a national sample of nasal allergy sufferer perspectives
on nasal allergies and their treatment
17
Pediatric Allergies in America
• Parents of 500 children with current allergies and 504 children
without nasal allergies (aged 4 - 17 years) were interviewed by
telephone about their children’s condition and treatment
– Children aged ≥ 10 years were also briefly queried on their
condition and treatment, if parent consented
• Criteria for participation in the survey
– Diagnosed by healthcare practitioner with allergic rhinitis,
nasal allergies, or “hay fever”
– Symptomatic (yes or no)
– Received treatment for their nasal allergies within
the previous 12 months
• In parallel, 501 healthcare practitioners were interviewed
• Interviews were conducted between March and April 2007
18
Pediatric Allergies in America
Study Design
Sampling
frame
Population
National RDD
Population aged 4 - 17
• With allergies
• Without allergies
Cross-section: 3/7/07 - 4/25/07
Health professional survey AMA/AOA Master List
• Pediatrics
• Family practice
• Allergy
• Otolaryngology
State Licensing Board
• Nurse practitioner
American Academy of
• Physician assistant
Physician Assistants
Interview
length
Completed
sample
36 minutes
18 minutes
500
504
20 minutes
Physician survey: 3/8/07 - 4/17/07
RDD = Random digit dialing; AMA = American Medical Association;
AOA = American Osteopathic Association.
100
100
101
100
50
50
Prevalence of Nasal Allergies in
Children: Results of a National
Telephone Survey
B Gordon,1 MS Blaiss,2 JM Boyle3
1Cape
Cod Ear, Nose, and Throat Specialists, Hyannis, MA;
2University of Tennessee Health Sciences Center, Memphis, TN;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
20
1 in 7 Children Has Been Diagnosed
With Nasal Allergies
Not diagnosed
86%
Diagnosed
14%
21
Prevalence of Allergies
100
Patients, %
80
Pediatric
Adult*
86%
86%
60
40
20
14%
14%
0
Diagnosed
Not diagnosed
Question from Pediatric Allergies in America survey: How many children, 4 to 17 years, in this
household have been diagnosed with hay fever, rhinitis, or nasal allergies and had symptoms
or taken medications for their nasal allergies in the past 12 months?
Question from Allergies in America survey: How many persons, 18 or older, in this household
have been diagnosed with hay fever, rhinitis, or nasal allergies?
*Blaiss MS, et al. Allergy Asthma Proc. 2007;28(suppl 1):S4-S10.
23
Age of Diagnosis of AR in Pediatric Patients
60
Patients, %
41%
40
20
34%
18%
4%
3%
> 13
Not sure
0
<3
3 to 6
7 to 12
24
Age of Diagnosis of AR in Adult Patients
40
Patients, %
33%
21%
20
14%
14%
7%
7%
4%
0
<6
6 to 17
18 to 29
30 to 39
40 to 59
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive
Summary. Altana Pharma US, Inc.; 2006.
> 60
Not sure
25
Diagnosing Physician
ENT = Ear, nose, and throat; OTO = Otolaryngologist.
26
Prevalence of Seasonal Versus Perennial
Allergies in Children
27
Time of Year for Nasal Allergy Symptoms
in Children
28
Outdoor Allergies Symptoms
Are More Bothersome in Children
Same
52%
Not sure
1%
Inside
3%
Outside
44%
29
Conclusions
• The reported prevalence of nasal allergies is high
(14%) among children in the United States
• The majority of children were diagnosed
by pediatricians
– Most children were diagnosed with nasal allergies
by age 6
• Seasonal allergies are reported more commonly than
perennial allergies in children
– Spring is the worst season for nasal allergy symptoms
in children
– Outdoor allergy symptoms are worse than
indoor allergies
Children With Nasal Allergies
Experience Bothersome Symptoms
That Affect Daily Activities
MS Blaiss,1 B Gordon,2 JM Boyle3
1University
of Tennessee Health Sciences Center, Memphis, TN;
2Cape Cod Ear, Nose, and Throat Specialists, Hyannis, MA;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
31
Daily Symptoms During
Worst Allergy Month
15%
Watering eyes
18%
Runny nose
Repeated sneezing
25%
Nasal congestion
25%
0
Every day
Most days
19%
16%
21%
27%
25
50
75
Respondents, %
100
During the worst one month period in the past year, did your [AGE] have [symptom]
every day, most days a week, a few days a week, a few days a month, less than that, or never?
N = 500.
32
Most Bothersome Symptoms
of Nasal Allergies
33
Bothersome Nasal Allergy Symptoms
16%
Dry cough
37%
22%
Red, itchy eyes
34%
18%
Headache
41%
Runny nose
25%
Postnasal drip
23%
0
40%
47%
32%
Nasal congestion
Extremely
Moderately
20
43%
40
60
Respondents, %
80
100
34
Degree of Discomfort During Nasal
Allergy Attack: Parents and Practitioners
ENT specialists
26%
71%
Family physicians
27%
70%
Allergists
55%
Pediatricians
41%
38%
Parents
56%
33%
0
20
57%
40
60
Category, %
ENT = Ear, nose, and throat.
Can't tolerate
Can't ignore
80
100
35
Conclusions
• Nasal congestion is the most frequent and bothersome
symptom of nasal allergies in children.
• Headache and cough are frequent symptoms of children
with nasal allergies
• More than 80% of parents and clinicians perceive that
children have significant degrees of discomfort from their
symptoms
• The severe symptoms of nasal allergies adversely affect
children’s daily lives
– Parents and physicians agree that allergy symptoms
cannot be ignored or tolerated in many children with nasal
allergies
Nasal Allergies
Adversely Affect Sleep and
Productivity in Children
MJ Derebery,1 EO Meltzer,2 JM Boyle3
1House
2Allergy
Ear Clinic, Los Angeles, CA;
and Asthma Medical Group and Research Center, San Diego, CA;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
37
Nasal Allergies Interfere With Sleep
Allergy
32%
Difficulty in
getting to sleep
No allergy
12%
26%
Waking up during
the night
8%
29%
Lack of a good
night’s sleep
12%
0
10
20
30
Respondents, %
40
50
38
Children’s Productivity Suffers When Nasal
Allergy Symptoms Are at Their Worst
Patient’s productivity
100
97
30% decrease
80
68
60
40
20
0
No symptoms
n = 486
Symptoms at worst
n = 487
39
Nasal Allergies Decrease Productivity in
Children: Reported by Health Professionals
ENT = Ear, nose, and throat.
40
Nasal Allergies Interfere at School/Daycare
50
Respondents, %
40%
40
30
20
11%
10
0
Allergy
No allergy
41
Nasal Allergies Limit Activity
in Children (Past 4 Weeks)
Allergy
No allergy
23%
Difficulty in performing
10%
23%
Accomplished less
10%
22%
Cut down on amount
10%
21%
Been limited in
kind of work
11%
0
10
20
30
Respondents, %
40
50
42
Conclusions
• Symptoms of nasal allergies negatively affect
sleep patterns
• Symptoms of nasal allergies negatively affect
productivity of children (presenteeism)
• Symptoms of nasal allergies interfere with
school and limit activities
• Effective control of nasal symptoms may
improve sleep quality and overall daytime
productivity
Nasal Allergies Reduce
Quality of Life in Children
EO Meltzer,1 AL Simmons,2 JM Boyle3
1Allergy
and Asthma Medical Group and Research Center,
San Diego, CA; 2University of Arkansas Medical Center,
Little Rock, AR; 3 Schulman, Ronca and Bucuvalas, Inc.,
New York, NY
44
Fewer Parents of Children With Allergies Rate
Their Children’s Overall Health as Excellent
Fewer Parents View Their Children’s Overall
Feelings of Well-Being to Be Positive
(Past 4 Weeks)
45
46
Children’s Emotional Status Affected by
Nasal Allergy Symptoms
47
Children’s Social Life Is Disrupted by
Nasal Allergy Symptoms
Allergy N = 493
No allergy N = 432
40%
Sleeping
7%
33%
Organized sports or exercising
10%
31%
Outdoor activities
7%
29%
Going out/Playing with friends
6%
27%
Having pets
4%
26%
Doing well in school
8%
22%
Doing things with family
5%
School activities
17%
4%
12%
Indoor activities
4%
0
10
20
30
Respondents, %
40
50
48
Conclusions
• Nasal allergies impair quality of life and limit
activities in children
– Compared to parents of children without allergies,
fewer parents describe their children with nasal
allergies as having excellent overall health or being
positive and full of life
– Parents perceive that nasal allergies made their
children irritable and tired
• Effective control of nasal symptoms may improve
the activity level and enhance quality of life
in children with nasal allergies
Parent and Physician Perspectives
on Nasal Allergy Treatment
in Children
AL Simmons,1 TA Mahr,2 JM Boyle3
1University
of Arkansas Medical Center, Little Rock, AR;
2Gundersen Lutheran Medical Center, La Crosse, WI;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
50
Introduction
• Nasal allergies are a common childhood malady
• Many treatment options exist, such as
over-the-counter and prescription allergy
medications, including intranasal corticosteroids
– Current treatments may not be effective or are
associated with side effects
– This results in dissatisfaction and failure to adhere to
prescribed therapy
• A better understanding of parent and physician
perspectives on the treatment of nasal allergies
could improve patient outcomes
51
Majority of Children With Nasal Allergies Use
Medication for Symptom Relief (Past 4 Weeks)
OTC = Over the counter.
52
Patients Very Satisfied With Disease Management:
Patient and Practitioner Perceptions
Allergists
77%
Pediatricians
75%
ENT
73%
Family practice
4%
3%
68%
NP/PA
Most (51% to 90%)
All (91% to 100%)
4%
2%
1%
58%
Very satisfied, %
68%
Patients
0
20
40
60
Respondents, %
ENT = Ear, nose, and throat; NP = Nurse practitioner;
PA = Physician’s assistant.
80
100
Practitioners, More So Than Parents,
Consider Prescription Allergy Medication
to Be Cost-Effective
100
88%
84%
82%
Respondents, %
80
80%
74%
63%
60
40
20
0
Pediatricians
Family
practice
Allergists
NP = Nurse practitioner; PA = Physician’s assistant;
ENT = Ear, nose, and throat.
NP/PA
ENT
Parents
53
54
Change of Children’s Prescription Medication
Not sure
3%
Never
40%
Several times
a year
8%
Once a year
8%
Only rarely
31%
Every few years
10%
55
Conclusions
• The majority of children with nasal allergies use
prescription or over-the-counter medications for
relief of their allergy symptoms
• The majority of parents and physicians are satisfied
with disease management
• However, improved efficacy could provide
better relief of nasal allergy symptoms for the
pediatric patient
– May also improve parent opinion on
cost-effectiveness of children’s nasal allergy
medications
Lack of Efficacy
and Bothersome Side Effects
Decrease Treatment Adherence in
Children With Allergic Rhinitis
TA Mahr,1 KK Sheth,2 JM Boyle3
1Gundersen
Lutheran Medical Center, La Crosse, WI;
2Lafayette Allergy and Asthma Clinic, Lafayette, IN;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
57
Most Parents Expect Relief of Children’s
Symptoms Within 3 Hours
≤ 1 hour
41%
1 - 3 hours
14%
4 - 6 hours
5%
7 - 9 hours
1%
10 - 12 hours
2%
13 - 24 hours
7%
≥ 25 hours
12%
Not sure
17%
0
10
20
30
Respondents, %
40
50
58
One Third of Parents Feel That 24-Hour
Relief of Children’s Symptoms Is Necessary
9%
< 6 hours
6 - 11 hours
20%
12 - 17 hours
14%
18 - 23 hours
3%
≥ 24 hours
33%
Not sure
19%
0
10
20
30
Respondents, %
40
50
59
Current Nasal Sprays Do Not Provide
24-Hour Relief
Not sure
1%
17%
< 4 hours
4 - 7 hours
37%
8 - 11 hours
17%
12 - 15 hours
16 - 23 hours
15%
3%
≥ 24 hours
0
11%
10
20
30
Respondents, %
40
50
Lack of Efficacy and Bothersome Side
Effects Contribute to Patient Dissatisfaction
With Nasal Allergy Medicine
Not sure
1%
Other
3%
Hard to administer
2%
Cost/Copay
1%
Didn't provide 24-hour relief
9%
Effectiveness wore off
10%
Bothersome side effects
18%
Wasn't effective
63%
0
20
40
60
Respondents, %
80
100
60
61
Frequency of Side Effects of Nasal
Allergy Medicines
21%
Dripping down throat
8%
19%
Bad taste
Drying feeling
5%
5%
Burning
6%
3%
10%
All
Most
Some
13%
9%
10%
7%
1%
Drowsiness
3%
9%
Headaches 3% 2% 5%
0
10
20
30
Respondents, %
Percentage of respondents reporting the side effects shared by some,
most, or all of their allergy medications.
40
50
Severity of Side Effects of
Nasal Allergy Medicines Are Moderately
to Extremely Bothersome
62
63
Conclusions
• Parents expect their children’s allergic rhinitis
medication to provide rapid, long-lasting
symptom relief
– Only half of patients report symptom relief
within 3 hours
– One third of parents report that their children’s
medication loses efficacy 4 to 7 hours after
administration
• One third of parents feel that 24-hour duration
of effect is a necessary attribute of their
children’s medication
• Most (88%) parents indicate loss of efficacy
within 24 hours
64
Conclusions (cont.)
• Frequent side effects of nasal allergy medications
include dripping down throat, bad taste, a drying
feeling, and burning
• More effective intranasal corticosteroids that provide
24-hour symptom relief and have an improved
tolerability profile may increase treatment adherence
in children with nasal allergies
Intranasal Corticosteroids That Provide
Rapid, Complete 24-Hour Symptom Relief
May Improve Treatment Satisfaction in
Children With Nasal Allergies
KK Sheth,1 MJ Derebery,2 JM Boyle3
1Lafayette
Allergy and Asthma Clinic, Lafayette, IN;
2House Ear Clinic, Inc, Los Angeles, CA;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
66
Use of Prescription Nasal Sprays
Not sure
1%
No
32%
Not sure
1%
Never
32%
Yes
67%
Past year
53%
More than
a year
14%
Ever used
Last 12 months
67
Symptom Relief From Current
Intranasal Corticosteroids
Some
29%
None
4%
Some
35%
Most
47%
Most
46%
All
17%
Not sure
3%
68
Onset of Relief From
Intranasal Corticosteroid Treatment
50
Respondents, %
40
31%
30
20
19%
19%
11%
10
4%
2%
0%
1%
1%
7 - 10
hours
11 - 23
hours
0
< 1hour 1 hour 2 hours
3-4
hours
5-6
hours
1-6
days
≥1
week
69
Does Effectiveness of Intranasal
Corticosteroids Wear Off?
Does not lose
effectiveness
36%
Not sure/
Refused
13%
Loses
effectiveness
51%
70
Why Changed Medication for
Nasal Allergies?
Not long-lasting
enough
4%
Didn't treat
symptoms
7%
Doctor wanted
to try other
22%
Not effective
enough
40%
0
10
20
30
Respondents, %
40
50
Less Than Half of Parents and Practitioners
Are Very Satisfied With Current
Intranasal Corticosteroids
NP/PA
18%
22%
ENT
Allergists
26%
31%
Family practice
37%
Pediatricians
33%
Parents
0
5
10
15
20
25
Respondents, %
NP = Nurse practitioner; PA = Physician’s assistant;
ENT = Ear, nose, and throat.
30
35
40
71
72
Conclusions
• All nasal allergy symptoms do not appear to be
relieved by intranasal corticosteroids
• The onset of relief from intranasal corticosteroids is
perceived by more than 60% of patients to be
≤ 2 hours
• Parents are dissatisfied with the lack of complete
nasal symptom relief provided by their children’s
intranasal corticosteroids
• This dissatisfaction led to parents changing their
children’s medications
73
Conclusions (con’t)
• Both practitioners and parents are not completely
satisfied with relief of children’s nasal allergy
symptoms by current intranasal corticosteroids
• This would suggest that intranasal corticosteroids
that provide rapid onset and a longer duration of
action may improve nasal symptom relief and
satisfaction with treatment