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 Boyle 9

2 Patient Perspectives on the Symptoms of Allergic Rhinitis and the Effect of Allergic Rhinitis on Daily Living 1 University of Tennessee Health Sciences Center, Memphis, TN; 2 Schulman, Ronca and Bucuvalas, Inc., New York, NY; 3 ALTANA Pharma US, Inc., Florham Park, NJ Michael S. Blaiss, 1 John M. Boyle, 2 Judith Droar 3

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., 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., 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., 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., Not past 12 months 12% Past 12 months 20% Never 68% 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., Interfered only 22% Neither 48% Missed work only 10% Both 20% Nasal Allergies Contribute to Absenteeism and 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., Mean productivity, % 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 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., A lot 15% Didn’t really impact 14% Moderate amount 25% Some 26% Not sure 1% Little 19% 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., Some of the time 13% All of the time 36% Most of the time 41% Not sure 1% 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 the time, 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 Boyle 9

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 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 Population Sampling frame Interview length Completed sample Population aged With allergies Without allergies National RDD 36 minutes 18 minutes 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 Board American Academy of Physician Assistants 20 minutes 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 1 Cape Cod Ear, Nose, and Throat Specialists, Hyannis, MA; 2 University of Tennessee Health Sciences Center, Memphis, TN; 3 Schulman, Ronca and Bucuvalas, Inc., New York, NY B Gordon, 1 MS Blaiss, 2 JM Boyle 3

20 1 in 7 Children Has Been Diagnosed With Nasal Allergies Diagnosed 14% Not diagnosed 86%

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% 14% DiagnosedNot diagnosed Patients, % Pediatric Adult*

22 Age of Diagnosis of Children With Nasal Allergies

23 Age of Diagnosis of AR in Pediatric Patients

24 Age of Diagnosis of AR in Adult Patients 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 Symptoms Are More Bothersome in Children Not sure 1% Same 52% Outside 44% Inside 3%

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 Boyle 3 1 University of Tennessee Health Sciences Center, Memphis, TN; 2 Cape Cod Ear, Nose, and Throat Specialists, Hyannis, MA; 3 Schulman, Ronca and Bucuvalas, Inc., New York, NY

31 Daily Symptoms During Worst Allergy Month 25% 18% 15% 27% 21% 16% 19% Nasal congestion Repeated sneezing Runny nose Watering eyes Respondents, % Every day Most 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% 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% 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 Allergies Adversely Affect Sleep and Productivity in Children MJ Derebery, 1 EO Meltzer, 2 JM Boyle 3 1 House Ear Clinic, Los Angeles, CA; 2 Allergy and Asthma Medical Group and Research Center, San Diego, CA; 3 Schulman, Ronca and Bucuvalas, Inc., New York, NY

37 29% 26% 32% 12% 8% 12% Lack of a good night’s sleep Waking up during the night Difficulty in getting to sleep Respondents, % No allergy Allergy Nasal Allergies Interfere With Sleep

38 Children’s Productivity Suffers When Nasal Allergy Symptoms Are at Their Worst Patient’s productivity No symptoms n = 486 Symptoms at worst n = % 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% AllergyNo allergy Respondents, %

41 Nasal Allergies Limit Activity in Children (Past 4 Weeks) Difficulty in performing Accomplished less Cut down on amount Been limited in kind of work 23% 22% 21% 10% 11% 10% Respondents, % Allergy No 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 Boyle 3 1 Allergy and Asthma Medical Group and Research Center, San Diego, CA; 2 University 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

45 Fewer 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, % % 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 life in children with nasal allergies

Parent and Physician Perspectives on Nasal Allergy Treatment in Children 1 University of Arkansas Medical Center, Little Rock, AR; 2 Gundersen Lutheran Medical Center, La Crosse, WI; 3 Schulman, Ronca and Bucuvalas, Inc., New York, NY AL Simmons, 1 TA Mahr, 2 JM Boyle 3

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, % Very satisfied, % 58% 68% 73% 75% 77% 1% 4% 3% 2% NP/PA Family practice ENT Pediatricians Allergists Most (51% to 90%) All (91% to 100%)

53 Practitioners, More So Than Parents, Consider Prescription Allergy Medication to Be Cost-Effective NP = Nurse practitioner; PA = Physician’s assistant; ENT = Ear, nose, and throat. Respondents, % 80% 63% 84% 88% 82% 74% ENTAllergistsPediatricians Family practice NP/PAParents

54 Change of Children’s Prescription Medication Several times a year 8% Not sure 3% Once a year 8% Every few years 10% Only rarely 31% Never 40%

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 Boyle 3 1 Gundersen Lutheran Medical Center, La Crosse, WI; 2 Lafayette Allergy and Asthma Clinic, Lafayette, IN; 3 Schulman, 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% ≤ 1 hour hours hours hours hours 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% < 6 hours hours hours hours ≥ 24 hours Not sure Respondents, %

59 Current Nasal Sprays Do Not Provide 24-Hour Relief Respondents, % 17% 37% 17% 15% 3% 11% 1% < 4 hours hours hours hours hours ≥ 24 hours Not sure

60 Lack of Efficacy and Bothersome Side Effects Contribute to Patient Dissatisfaction With Nasal Allergy Medicine Respondents, % 63% 18% 10% 9% 1% 2% 3% 1% 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% Dripping down throat Bad taste Drying feeling Burning Drowsiness Headaches Respondents, % All Most Some

62 Severity of Side Effects of Nasal 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 1 Lafayette Allergy and Asthma Clinic, Lafayette, IN; 2 House Ear Clinic, Inc, Los Angeles, CA; 3 Schulman, Ronca and Bucuvalas, Inc., New York, NY KK Sheth, 1 MJ Derebery, 2 JM Boyle 3

66 Use of Prescription Nasal Sprays Last 12 months Not sure 1% More than a year 14% Never 32% Past year 53% Ever used Not sure 1% Yes 67% No 32%

67 Symptom Relief From Current Intranasal Corticosteroids Some 35% Most 46%

68 Onset of Relief From Intranasal Corticosteroid Treatment 19% 31% 11% 2% 0% 1% 19% 4% < 1hour 1 hour2 hours hours hours hours hours days ≥ 1 week Respondents, %

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? 40% 22% 7% 4% Not effective enough Doctor wanted to try other Didn't treat symptoms Not long-lasting enough Respondents, %

71 Less Than Half of Parents and Practitioners Are 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%

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