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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
1University of Tennessee Health Sciences Center, Memphis, TN; 2Schulman, Ronca and Bucuvalas, Inc., New York, NY;
3ALTANA Pharma US, Inc., Florham Park, NJ
Michael S. Blaiss,1 John M. Boyle,2 Judith Droar3
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
• 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.
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers
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
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
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
7
Common Nasal Allergy Symptoms Are Bothersome
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
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
8
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
Not past12 months
12%
Past 12 months
20%
Never68%
32% of Patients With Nasal Allergies Have Comorbid Asthma
Have you ever been diagnosed with asthma? Have you had asthma in the past 12 months? N = 2,500
9
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
Interferedonly22%
Neither48%
Missed workonly 10%
Both20%
Nasal Allergies Contribute to Absenteeismand Interfere With Patient Performance at Work
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
10
When Nasal Allergy Symptoms Are at Their Worst, Work Productivity Declines by 23%
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
Mea
n p
rod
uct
ivit
y, %
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
11
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
A lot15%
Didn’t really impact
14%
Moderateamount
25%
Some26%
Not sure1%
Little19%
The Majority of Patients Believe That Nasal Allergies Affect Daily Living
During allergy season, would you say the condition impacted you daily life? N = 2,500
12
64% of Patients Do Not Always Adhere to Health Practitioner Advice
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. ALTANA Pharma US, Inc., 2006.
Some of the time13%
All of the time36%
Most of the time 41%
Not sure1%
Never, 4%
Rarely, 4%
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 thetime, some of the time, rarely, or never? N = 2,500
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 credibledata-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 obtaina national sample of nasal allergy sufferer perspectiveson 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
PopulationSampling
frameInterview
lengthCompleted
sample
Population aged 4 - 17• With allergies• Without allergies
National RDD
36 minutes18 minutes
500504
Cross-section: 3/7/07 - 4/25/07
Health professional survey• Pediatrics• Family practice• Allergy• Otolaryngology• Nurse practitioner• Physician assistant
AMA/AOA Master List
State Licensing BoardAmerican Academy ofPhysician Assistants
20 minutes
1001001011005050
Physician survey: 3/8/07 - 4/17/07
Study Design
RDD = Random digit dialing; AMA = American Medical Association; AOA = American Osteopathic Association.
Prevalence of Nasal Allergies in Children: Results of a National
Telephone Survey
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
B Gordon,1 MS Blaiss,2 JM Boyle3
20
1 in 7 Children Has Been DiagnosedWith Nasal Allergies
Diagnosed14%
Not diagnosed86%
21
Prevalence of Allergies
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.
14%
86% 86%
14%
0
20
40
60
80
100
Diagnosed Not diagnosed
Pa
tien
ts, %
Pediatric
Adult*
23
Age of Diagnosis of AR in Pediatric Patients
18%
41%
34%
4% 3%
0
20
40
60
< 3 3 to 6 7 to 12 > 13 Not sure
Pat
ien
ts,
%
24
Age of Diagnosis of AR in Adult Patients
7%
33%
21%
14% 14%
4%7%
0
20
40
< 6 6 to 17 18 to 29 30 to 39 40 to 59 > 60 Not sure
Pat
ien
ts, %
Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. Altana Pharma US, Inc.; 2006.
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 SymptomsAre More Bothersome in Children
Not sure1%
Same52%
Outside44%
Inside3%
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 AllergiesExperience 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
25%
25%
18%
15%
27%
21%
16%
19%
0 25 50 75 100
Nasal congestion
Repeated sneezing
Runny nose
Watering eyes
Respondents, %
Every dayMost days
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
43%
47%
40%
41%
34%
37%
32%
23%
25%
18%
22%
16%
0 20 40 60 80 100
Nasal congestion
Postnasal drip
Runny nose
Headache
Red, itchy eyes
Dry cough
Respondents, %
Moderately
Extremely
34
Degree of Discomfort During Nasal Allergy Attack: Parents and Practitioners
ENT = Ear, nose, and throat.
33%
38%
27%
26%
56%
70%
71%
57%
0 20 40 60 80 100
Parents
55% 41%Allergists
Pediatricians
Family physicians
ENT specialists
Category, %
Can't tolerate
Can't ignore
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 AllergiesAdversely Affect Sleep and
Productivity in Children
MJ Derebery,1 EO Meltzer,2 JM Boyle3
1House Ear Clinic, Los Angeles, CA;2Allergy and Asthma Medical Group and Research Center, San Diego, CA;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
37
29%
26%
32%
12%
8%
12%
0 10 20 30 40 50
Lack of a goodnight’s sleep
Waking up duringthe night
Difficulty ingetting to sleep
Respondents, %
No allergy
Allergy
Nasal Allergies Interfere With Sleep
38
Children’s Productivity Suffers When Nasal Allergy Symptoms Are at Their Worst
Pat
ien
t’s
pro
du
ctiv
ity
97
68
0
20
40
60
80
100
No symptomsn = 486
Symptoms at worstn = 487
30% decrease
39
Nasal Allergies Decrease Productivity in Children: Reported by Health Professionals
ENT = Ear, nose, and throat.
40
Nasal Allergies Interfere at School/Daycare
40%
11%
0
10
20
30
40
50
Allergy No allergy
Res
po
nd
ents
, %
41
Nasal Allergies Limit Activityin Children (Past 4 Weeks)
Difficulty in performing
Accomplished less
Cut down on amount
Been limited inkind of work
23%
23%
22%
21%
10%
11%
10%
10%
0 10 20 30 40 50
Respondents, %
AllergyNo allergy
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
45Fewer Parents View Their Children’s Overall Feelings of Well-Being to Be Positive
(Past 4 Weeks)
46
Children’s Emotional Status Affected by Nasal Allergy Symptoms
47
Children’s Social Life Is Disrupted by Nasal Allergy Symptoms
Respondents, %
0 10 20 30 40 50
33%10%
Organized sports or exercising
26%8%Doing well in school
17%4%School activities
22%5%Doing things with family
29%6%Going out/Playing with friends
27%4%Having pets
31%7%Outdoor activities
12%4%Indoor activities
7%40%Sleeping
Allergy N = 493
No allergy N = 432
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 lifein children with nasal allergies
Parent and Physician Perspectives on Nasal Allergy Treatment
in Children
1University of Arkansas Medical Center, Little Rock, AR; 2Gundersen Lutheran Medical Center, La Crosse, WI; 3Schulman, Ronca and Bucuvalas, Inc., New York, NY
AL Simmons,1 TA Mahr,2 JM Boyle3
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
ENT = Ear, nose, and throat; NP = Nurse practitioner;PA = Physician’s assistant.
68%Patients
Respondents, %0 20 40 60 80 100
Very satisfied, %
58%
68%
73%
75%
77%
1%
4%
4%
3%
2%
NP/PA
Family practice
ENT
Pediatricians
Allergists Most (51% to 90%)All (91% to 100%)
53Practitioners, More So Than Parents,Consider Prescription Allergy Medication
to Be Cost-Effective
NP = Nurse practitioner; PA = Physician’s assistant;ENT = Ear, nose, and throat.
Res
po
nd
ents
, %
80%
63%
84%88%
82%74%
0
20
40
60
80
100
ENTAllergistsPediatricians Familypractice
NP/PA Parents
54
Change of Children’s Prescription Medication
Several timesa year
8%
Not sure3%
Once a year8%
Every few years10%
Only rarely31%
Never40%
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 Efficacyand 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
41%
14%
5%
1%
2%
7%
12%
17%
0 10 20 30 40 50
≤ 1 hour
1 - 3 hours
4 - 6 hours
7 - 9 hours
10 - 12 hours
13 - 24 hours
≥ 25 hours
Not sure
Respondents, %
58
One Third of Parents Feel That 24-Hour Relief of Children’s Symptoms Is Necessary
9%
20%
14%
3%
33%
19%
0 10 20 30 40 50
< 6 hours
6 - 11 hours
12 - 17 hours
18 - 23 hours
≥ 24 hours
Not sure
Respondents, %
59
Current Nasal Sprays Do Not Provide24-Hour Relief
Respondents, %
17%
37%
17%
15%
3%
11%
1%
0 10 20 30 40 50
< 4 hours
4 - 7 hours
8 - 11 hours
12 - 15 hours
16 - 23 hours
≥ 24 hours
Not sure
60Lack of Efficacy and Bothersome Side Effects Contribute to Patient Dissatisfaction
With Nasal Allergy Medicine
Respondents, %
63%
18%
10%
9%
1%
2%
3%
1%
0 20 40 60 80 100
Wasn't effective
Bothersome side effects
Effectiveness wore off
Didn't provide 24-hour relief
Cost/Copay
Hard to administer
Other
Not sure
61
Frequency of Side Effects of Nasal Allergy Medicines
Percentage of respondents reporting the side effects shared by some, most, or all of their allergy medications.
21%
19%
5%
6%
3%
8% 13%
9%
10%
7%
9%
5%
3%
10%
5%
3%
1%
2%
0 10 20 30 40 50
Dripping down throat
Bad taste
Drying feeling
Burning
Drowsiness
Headaches
Respondents, %
AllMostSome
62Severity of Side Effects ofNasal Allergy Medicines Are Moderately
to Extremely Bothersome
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
1Lafayette Allergy and Asthma Clinic, Lafayette, IN; 2House Ear Clinic, Inc, Los Angeles, CA;
3Schulman, Ronca and Bucuvalas, Inc., New York, NY
KK Sheth,1 MJ Derebery,2 JM Boyle3
66
Use of Prescription Nasal Sprays
Last 12 months
Not sure1%
More thana year14%
Never32%
Past year53%
Ever used
Not sure1%
Yes67%
No32%
67
Symptom Relief From CurrentIntranasal Corticosteroids
Some35%
Most46%
Not sure 3%
None 4%
Some 29%
Most 47%
All 17%
68
Onset of Relief FromIntranasal Corticosteroid Treatment
19%
31%
11%
2%0% 1% 1%
19%
4%
0
10
20
30
40
50
< 1hour 1 hour 2 hours 3 - 4hours
5 - 6hours
7 - 10hours
11 - 23hours
1 - 6days
≥ 1week
Res
po
nd
ents
, %
69
Does Effectiveness of Intranasal Corticosteroids Wear Off?
Does not loseeffectiveness
36%Not sure/Refused
13%
Loseseffectiveness
51%
70
Why Changed Medication for Nasal Allergies?
40%
22%
7%
4%
0 10 20 30 40 50
Not effectiveenough
Doctor wantedto try other
Didn't treatsymptoms
Not long-lastingenough
Respondents, %
71
Less Than Half of Parents and PractitionersAre Very Satisfied With Current
Intranasal Corticosteroids
NP = Nurse practitioner; PA = Physician’s assistant;ENT = Ear, nose, and throat.
Respondents, %
NP/PA
ENT
Allergists
Family practice
Pediatricians
Parents
18%
22%
26%
31%
37%
33%
0 5 10 15 20 25 30 35 40
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