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,

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