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CLARITIN ® (10 mg loratadine) OTC Indication for Chronic Idiopathic Urticaria. Schering Corporation April 22, 2002. Background. Joint Non-Prescription Drug and Pulmonary-Allergy Advisory Committees review on May 11, 2001: Loratadine (10 mg daily) is safe for OTC

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claritin 10 mg loratadine otc indication for chronic idiopathic urticaria

CLARITIN®(10 mg loratadine)OTC Indication for Chronic Idiopathic Urticaria

Schering Corporation

April 22, 2002

background
Background

Joint Non-Prescription Drug and Pulmonary-Allergy Advisory Committees review on May 11, 2001:

Loratadine (10 mg daily) is safe for OTC

treatment of allergic rhinitis

objective
Objective

To consider loratadine for treating episodes of chronic idiopathic urticaria (CIU) OTC following an initial physician diagnosis

agenda
Agenda

Overview John M. Clayton, Ph.D.

Clinical Overview of Urticaria Eugene W. Monroe, M.D.

Schering Studies on CIU Stephen Neumann

Risk/Benefit Analysis and Conclusions John M. Clayton, Ph.D.

ciu as an otc indication
CIU as an OTC Indication
  • In-depth Review of CIU Indication
  • New Studies
    • CIU Patient Study
    • Physician Practices
    • Consumer Self-Recognition
    • Label Comprehension
  • Claritin® Worldwide Safety Review
  • Expert Panel Review
findings
Findings
  • CIU is generally not associated or confused with more serious conditions
  • CIU is currently managed by consumers as a self-treated condition
  • Physicians and consumers are comfortable with consumers’ ability to self-recognize recurring episodes of CIU
findings7
Findings
  • Consumers already self-treat with OTC sedating antihistamines
  • Claritin® is safe for OTC treatment of CIU and provides a better risk/benefit alternative
  • Adequate labeling can be developed for Claritin® OTC for safe and effective OTC use in CIU following an initial physician diagnosis
urticaria hives

URTICARIA (Hives)

Eugene W. Monroe, M.D.

Department of Dermatology, Advanced Healthcare

Assistant Clinical Professor, Medical College of Wisconsin

objectives of presentation
Objectives of Presentation
  • Overview of Urticaria (Hives)
    • Classification
    • Diagnostic Evaluation
    • Management
  • Consequences of (consumer/patient) misdiagnosis?
slide10

Urticaria (Hives):

    • Skin reaction pattern characterized by transient, pruritic, edematous,
    • lightly erythematous papules or wheals, frequently with central clearing
differentiating acute from chronic urticaria hives
Differentiating Acute from Chronic Urticaria (Hives)
  • Acute Urticaria (Hives)
      • Duration of few days to few weeks
      • Incidence of 15-20% of population
      • Etiology usually detected
      • Most cases are mild and never seen by physician
  • Chronic Urticaria (Hives)
      • Duration greater than six weeks
      • Ranges from continuous (almost daily) to recurrent (symptom free intervals of days to many weeks)
      • Course variable from months to years
      • Incidence of up to 3% of population
      • Etiology not found in 90-95% of cases = IDIOPATHIC (cause unknown or not determined)
potential causes of urticaria hives
Drugs

Foods

Infections

Psychogenic Factors

Physical Agents

Inhalants

Contactants

Genetic Factors

Internal Diseases (Connective Tissue Disorders, Vasculitis, Thyroid, etc.)

Potential Causes of Urticaria (Hives)

Most Common Causes

Other Causes

diagnosing chronic idiopathic urticaria chronic hives of unknown cause
Diagnosing Chronic Idiopathic Urticaria (Chronic Hives of Unknown Cause)
  • History & Physical Examination
      • Detailed history is most important diagnostic test
        • Review of systems
        • Review of the potential causes for hives
      • Physical exam
      • Laboratory and diagnostic tests only ordered based on clues from history and physical exam
  • CIU - a Diagnosis of Exclusion
management of acute urticaria hives
Management of Acute Urticaria (Hives)
  • Elimination or reduction of underlying cause
  • Patient Education
    • Natural course of disease and etiologies
    • Possible complications and associated conditions and appropriate actions
  • Drug Therapy
    • H1 antihistamine
management of chronic idiopathic urticaria
Management of Chronic Idiopathic Urticaria
  • Reduction or avoidance of non-specific aggravating factors
  • Patient Education
    • Natural course of disease and etiologies
    • Possible complications and appropriate actions
  • Drug therapy
treatment algorithm for chronic idiopathic urticaria
Treatment Algorithm for Chronic Idiopathic Urticaria
  • H1 antihistamines - (Non-sedating preferred)
  • H1 antihistamine + other H1 & H2 receptor blockers, inhibitors of other mediators, or inhibitors of the inflammatory and cellular reaction
    • Additional medications are used when the symptoms persist and efficacy is not optimal with monotherapy
spectrum of urticaria patients
Spectrum of Urticaria Patients
  • Range of Urticaria (hive) patients:
    • a milder (self-limiting) form to very severe (refractory)
  • Range of consumer/patient participation with the physician:
    • not seeing physician & self treating to active participation
  • Treatment of Urticaria Patients
    • standard of care H1 antihistamines
most likely conditions confused or misdiagnosed for ciu
Most Likely Conditions Confused or Misdiagnosed for CIU
  • Acute/Chronic Urticaria (Hives)
  • Eczema/Contact Dermatitis
  • Angioedema
consequences of misdiagnosis
Consequences of Misdiagnosis

Acute Urticaria (Hives)

  • Vast majority of cases mild & self-limiting
  • An appropriate treatment for acute hives is an antihistamine
consequences of misdiagnosis20
Consequences of Misdiagnosis

Chronic Urticaria

  • 5-10% have an identifiable cause
  • Patients will usually be driven to the physician due to:
    • severity/persistence of itching
    • failure to respond to self-treatment
    • presence of other signs and symptoms suggestive of a more serious condition (joint pain, fever, discoloration of the hives etc.)
consequences of misdiagnosis21
Consequences of Misdiagnosis

Dermatitis/Eczema

  • Most likely confusion with other “itchy rashes”(e.g. Contact Dermatitis, Eczema)
  • Patients will usually seek a physician when:
    • changing severity/persistence of symptoms
    • failure to respond to self-treatment
consequences of misdiagnosis22
Consequences of Misdiagnosis

Angioedema

  • Angioedema & urticaria can co-exist and can sometimes be confused with each other
  • Angioedema are giant hives or hives involving mucous membranes and tissues around the eyes, lips or genitalia
  • Histologically involves deeper layers of skin than urticaria
  • Although visually more noticeable than urticaria, present no additional serious consequences to the patient
  • No difference with clinical treatment
anaphylaxis
Anaphylaxis
  • An immediate systemic allergic reaction produced by the release of mediators from mast cells and basophils
    • Simultaneously involves
      • Skin manifestations (hives)
      • Respiratory systems- (dyspnea, wheeze)
      • CV system (dizziness, syncope, hypotension)
      • GI system (nausea, vomiting, diarrhea)
  • Incidence of anaphylaxis is rare1,2

1. Yocum, Rochester Epidemologic Study - Journ Allergy Clin Immuno 104:452-6, 1999

2. Neugut, Arch. Int. Med. Vol.161, Jan 8, 2001

anaphylaxis cont
Anaphylaxis (cont.)
  • Chronic urticaria is not associated with nor is it a risk factor for the development of anaphylaxis 3
  • Acute urticaria is an associated symptom with anaphylaxis but the rapid simultaneous onset of CV or Respiratory symptoms will cause the patient to seek immediate medical attention
    • Respiratory and Cardiovascular symptoms most always occur within 30 minutes of presentation of the hives

3. Winbery, Lieberman, Immun Clinic North America Vol 15 no 3 Aug ‘95

conclusions
Conclusions
  • Cardinal features of urticaria (acute or chronic)
    • cutaneous wheals, redness and itching
  • Diagnosis of Chronic Idiopathic Urticaria
    • a diagnosis of exclusion by physicians
  • Consequences of patient misdiagnosis represents a low safety risk
  • Availability of OTC non-sedating H1 antihistamines in CIU:
    • Better safety profile (vs.current OTC antihistamines)
    • Creates opportunity for better care through labeling and patient education
schering conducted four studies

Study

Purpose

Consumer Habits and Practices Study (N=388)

Understand how patients with CIU recognize and treat their symptoms

Physician Practices Study

(N= 359)

Understand physician practices and perceptions regarding CIU among a representative sample of key specialties

Consumer Self-Recognition Study

(N=196)

Label Comprehension Study

(N=565)

Learn how well CIU patients self-recognize CIU and its symptoms and self-manage after initial physician diagnosis

Schering Conducted Four Studies

Understand consumer’s ability to

comprehend certain communications

points on the draft label

consumer study design
Consumer Study Design

Screening of Subjects

  • Internet panel screened via e-mail questionnaire to identify physician-diagnosed CIU sufferers
  • Question Posed
    • “Have you ever been diagnosed by a medical doctor as having chronic or recurrent hives that have no known discernable cause, also known as chronic idiopathic urticaria?”

Re-screening/Validation of Subjects

  • Random sample drawn from CIU sampling frame and asked to log on to a website to complete a more detailed questionnaire
    • Subjects were re-screened for physician diagnosed CIU at log in
  • Literature on consumer research supports that most respondents provide accurate responses to study questions on personal health issues such as conditions personally suffered (excluding sensitive topics such as STD’s)
consumer study design29

Consumer Study

Population

US Adult (18+) Population

Age: 18-24

4%

13%

25-29

7

9

30-39

21

21

40-49

29

21

50-59

27

14

60-69

9

10

70+

3

12

Sex: Male

34

48

Female

66

52

Consumer Study Design

Study Population

  • Final sample (N=388) is representative of larger pool of CIU responders and has a profile consistent with key demographics reported with CIU
    • Female; Middle aged
consumer study design30
Consumer Study Design
  • Survey questions comprised primarily of a variation of closed-ended or multiple choice type questions
    • Subjects could type in responses whenever pre-set lists did not meet their needs
    • All key questions had this option
    • Possible response lists were rotated to minimize order bias in presentation
  • Closed ended questions are a standard, accepted practice in survey research and offer a number of advantages
    • Are a good choice when the options are limited and can be foreseen
    • Permit direct comparison of responses from subject to subject
    • Address the issue that most respondents will not write elaborate answers
    • Avoid interviewer recording/probing biases present in open-ends
    • Avoid errors associated with coding/ categorization of responses
frequency of suffering

(N=388)

Frequency of Suffering

42%

3 or More

Episodes/Year

66%

34%

24%

Mean = 3.4 times

  • CIU sufferers are experienced, frequent sufferers making it a readily recognizable condition
slide34

Symptoms of CIU

Note: Responses do not equal 100

due to multiple responses

(N=388)

  • There is significant consistency in symptoms described by CIU sufferers
  • Symptoms that could be confused with the most threatening manifestations
  • of anaphylaxis are rarely mentioned
slide35

Q. Thinking about when the hives appeared prior to seeing a physician, what, if anything, did you do to treat or relieve the condition?

(Question context is prior to diagnosis of CIU)

action at initial occurrence
Action at Initial Occurrence

Total (N=388)Used any OTC- topical or systemic (Net) 70 %

Took an OTC antihistamine such as Benadryl or Chlor-Trimeton62 %

Used a topical anti-itch cream such as Benadryl 36 %

Used a topical anti-itch lotion such ascalamine lotion 46 %

Note: Multiple Mentions

  • Self-medication prior to physician diagnosis is a common behavior and OTC
  • oral antihistamines are commonly used
physician care
Physician Care
  • One-third (33%) of study subjects have not seen a physician for CIU in the past year
  • Nearly one-fifth (19%) report that they have not seen a physician since initial diagnosis
  • A notable proportion of patients are not under continual care
typical action upon recurrence
Typical Action Upon Recurrence

(N=388)

Use prescribed medication already on hand 52%

Use OTC medication 43

Call/visit physician 20

Take bath/soothing bath/soak wash areas 3

Nothing/wait it out/no longer have problem 8

Go to emergency room 1

All other mentions 5

Note: Multiple Mentions

  • Patients self-manage CIU with the use of both prescription
  • medications on hand and OTC medications
physician contact

(N=388)

Subjects Who Call/Visit

Physician 20 %

When Contact Physician

Every time 4 %

Sometimes 4 %

Only when symptoms don’t respond

to current treatments/medication(s) 7 %

Only when a more serious symptom

such as swelling of face/mouth occurs 2 %

No answer 3 %

Physician Contact
  • Most physician contact comes about when symptoms don’t
  • respond or more serious symptoms occur
slide42

Q. Now that your condition has been diagnosed by a physician, how easy is it for you to identify this condition when it reappears?

ability to self recognize ciu
Ability to Self-Recognize CIU

(N=388)

Ease of Recognition

Very easy 80 %

Somewhat easy 14 %

Very/Somewhat Easy94 %

Neither easy nor difficult 6 %

Somewhat difficult -

Very difficult -

  • Once diagnosed by a physician as having CIU
  • 80% of patients perceive it is very easy to identify the
  • condition when it reappears
  • - No respondents reported difficulty
slide44

Q. What would you do if you experienced other symptoms such as difficulty breathing, fever or trouble swallowing with your hives?

presence of serious symptoms

95%

Presence of Serious Symptoms

(N=388)

* Less than 1%

  • 95% of patients claim that they would seek medical assistance
  • if more serious symptoms arose
  • This response is without the benefit of labeling to direct them
conclusions consumer study
Conclusions: Consumer Study
  • Consumers confirm that recurrent episodes of CIU are easily recognized
  • Physician diagnosed CIU is largely self-managed
    • Nearly 20% do not return for a physician visit
  • Treatment with OTC antihistamines prior to physician diagnosis is prevalent (62%)
  • Consumers know to seek medical attention if serious symptoms occur
physician practices study design
Physician Practices Study Design

Physician Screening

  • Internet panel of physicians combined with a pool of physicians from Medscape and ePocrates totaling 200,000
  • Pool of physicians screened as to specialty and treatment of CIU patient
  • Once qualified, more detailed survey conducted
physician practices study design48
Physician Practices Study Design

Study Population

  • Random sample drawn was representative of and projectable to office-based practicing physicians with web access (96%) in the specialties studied
  • Total of 359 interviews
    • PCP’s , Dermatologists, Allergists, Pediatricians
nomenclature used to describe ciu
Nomenclature Used To Describe CIU

(N=359)

  • Nearly three-fourths of physicians use either “chronic” or “recurring”
  • hives in describing CIU to their patients
slide51

Q. After receiving a diagnosis of chronic idiopathic urticaria from a physician, howlikely do you feel a sufferer is ableto self-identify or recognize recurrent episodes of this condition?

likelihood of recognizing recurrent episodes
Likelihood of Recognizing Recurrent Episodes

Perceived Likelihood to Identify

Recurrent Episodes: After

Physician Diagnosis

(N=359) Very/Somewhat Likely96 %

Very Likely 60 %

Somewhat Likely 36 %

  • 96% of physicians feel that it is likely that a previously diagnosed CIU
  • patient can self-recognize recurrent episodes
slide53

Q. Thinking of all the patients you have counseled for chronic idiopathic urticariawhat percentage do you recommend keep medicine on hand in anticipation of a recurrent episode ?

physician encouraged self management practices
Physician Encouraged Self-Management Practices
  • Virtually all (97%) physicians counsel some CIU patients to keep medications on hand in case of an outbreak of hives
  • Just under 60% of physicians counsel ALL of their CIU patients to keep medications on hand
conclusions physician practices study
Conclusions: Physician Practices Study
  • Physicians demonstrate consensus in the nomenclature they use to describe CIU to patients (Chronic hives; recurrent hives)
  • 96% of physicians believe it is likely that patients can self-recognize recurrent outbreaks
    • Confirms learning of other studies
  • Physician prescribing/ recommendation behavior encourage CIU patient self-management
self recognition study
Self Recognition Study

Study Design

  • “All comers” study to determine if consumers that have been diagnosed by a physician as having recurrent or chronic hives of an unknown origin can accurately self-recognize the condition and symptoms upon recurrence

Study Population

  • Subjects with physician diagnosed CIU (N=196)

Study Method

  • CIU patients recruited from 21 regionally dispersed cities via radio/newspaper advertising
  • Required to bring the name and telephone number of the diagnosing physician with them
self recognition study57
Self Recognition Study

Study Method (Cont’d)

  • CIU Subjects:
    • Medical history taken along with photograph of lesions if suffering
    • Patients who were not suffering reviewed alternative textbook photos of lesions and selected one which looks most like theirs
    • Materials sent to/reviewed by physician: Teleconference with patient
    • Physician and dermatologist reviewed all information to determine if subject had accurately self-recognized CIU
confirmed self recognition
ConfirmedSelf-Recognition

94%

Agreement Between Patient

And Physician

  • Nearly all of the subjects who reported having CIU were
  • confirmed by the investigating physician and dermatologist as
  • having CIU
conclusions self recognition study
Conclusions: Self-Recognition Study
  • Previously diagnosed CIU patients can accurately self-recognize the symptoms and condition upon recurrence
  • This is consistent with the findings of both the Consumer and Physician studies
label comprehension study
Label Comprehension Study

Study Design

  • “All comers” study to understand the consumer’s ability to comprehend specific communications points on the draft label

Study Population (N=565)

  • CIU Sufferers (N = 196)
  • General Population (N=116)
  • Low Literate (N = 96)
  • “Ask a doctor first” Subjects that were either pregnant, nursing/breast feeding or had liver or kidney disease (N=114)
  • Acute Hives Sufferers (N=102)
label comprehension study61
Label Comprehension Study

Study Method

  • CIU cohort recruited via advertising
  • Other cohorts recruited via mall intercepts and special locations for the enriched populations
  • Label comprehension was assessed by asking both direct and scenario-based questions
  • Self-selection was assessed by posing a question to determine if consumers understood they could personally use Claritin®
label comprehension study62
Label Comprehension Study

Findings

  • Through reactions to scenarios, consumers across all cohorts demonstrated a strong understanding …
    • That this product should not be used in situations where serious symptoms are present – General Warnings (75-96% Correct/Acceptable Responses)
    • Of who can and cannot use Claritin® (75-99% Correct/Acceptable)
    • Of conditions under which one must ask a doctor before use (94-100% Correct/Acceptable)
    • Of conditions under which the product should be used (95-100% Correct/Acceptable)
label comprehension study63
Label Comprehension Study

Findings

  • Responses to scenarios and questions among the target cohort of CIU sufferers was particularly strong (91 – 99% – Correct/Acceptable)
  • CIU patients also demonstrated appropriate self-selection for personal use (100%)
label comprehension
Label Comprehension

Findings

  • A majority of acute hives sufferers (54%) correctly de-selected the product for personal use
  • When presented with a direct scenario of acute hives, 75% of this cohort correctly comprehended that the product should not be used
  • This level of correct self-selection leads us to feel positive that we can optimize labeling
label comprehension65
Label Comprehension

N=116

Correct/Acceptable

Incorrect

% - Percent of General Population

  • A significant majority of the general population demonstrates
  • appropriate self-selection
conclusions label comprehension study
Conclusions: Label Comprehension Study
  • Reaction to the scenarios across all cohorts demonstrates understanding of the general warnings, situations in which Claritin® should/should not be used and directions for use
  • Results of the self-selection/personal use question reveal that a majority of the general population can appropriately self-select the product for use
conclusions label comprehension study67
Conclusions: Label Comprehension Study
  • Over half of the acute hives study subjects appropriately de-selected the product in the personal use question and scenario responses demonstrate that this population understands the warnings.
    • Notably this result was achieved with draft labeling that requires refinement
    • We are committed to work with FDA to refine the labeling to improve comprehension among these consumers
  • Based on self-selection and response to scenarios, consumers with a physician diagnosis of CIU understand that this product is for them and are likely to use it correctly.
risk benefit of claritin otc
Risk/Benefit of Claritin® OTC
  • FDA analysis of safety of Claritin including CIU experience supports safety for OTC
  • Worldwide marketing experience as an Rx and OTC product supports switch
claritin marketing history
Claritin® Marketing History
  • Launched in Belgium in 1988 (AR and CIU)
  • Approved in 114 countries
  • Approved OTC in 33 countries
    • Approved OTC in Canada in 1990 for “Skin Itching/Urticaria”
    • Approved OTC in U.K. in 1993 for “Hives/Urticaria”
  • Approved Rx in U.S. in 1995 for “CIU”
claritin patient exposure
Claritin® Patient Exposure
  • Approximately 14 billion patient days
    • Half within the U.S.
  • 457 million courses of treatment
claritin safety
Claritin® Safety
  • Excellent safety profile (2 AE reports per 100,000 courses of treatment)
  • Serious adverse event reports are rare
  • Not a drug of abuse
  • Adverse events in CIU are similar between OTC and Rx
poison center data on loratadine
Poison Center Data on Loratadine
  • No new signals
  • No new medical issues

Toxic Exposure Surveillance System Database 1997-2001

claritin otc examples of labeled indications
Claritin® OTC Examples of Labeled Indications

Australia “chronic urticaria (hives), itchy rash”

Canada “allergic skin conditions, hives”

Germany “chronic urticaria (hives) with itching”

Switzerland “chronic hives (urticaria)”

United Kingdom “allergic skin conditions, rash, itching,

and urticaria (hives)”

otc marketing experience canada and united kingdom
OTC Marketing ExperienceCanada and United Kingdom
  • Overall safety experience OTC is similar to prescription experience
  • OTC experience in general skin allergy/urticaria/CIU is similar to rhinitis experience

Based on total of 38 million patient days of exposure

  • Indications: Hives, rash, allergic skin conditions, allergic dermatologic conditions
claritin safety conclusion
Claritin® Safety--Conclusion
  • Clinical trial and extensive worldwide marketing experience document an extremely safe profile for Claritin for CIU
  • Claritin OTC has a safe profile worldwide in an OTC setting
risk benefit conclusions
Risk/Benefit Conclusions
  • Current practices and standards of care support CIU as OTC indication
    • Multiple refills
    • OTC medications
    • Limited physician oversight
  • Consumers currently self-treat with sedating OTC antihistamines for all forms of urticaria without labeling for this indication
  • CIU patients would benefit from OTC access to first-line, non-sedating therapy for recurrent episodes
  • Proper OTC labeling and patient education will aid consumers in better treatment of CIU
claritin otc consumer and health professional education program
Claritin® OTCConsumer and Health Professional Education Program

Focus

  • Information and education about conditions
  • Recognizing if Claritin is appropriate for condition
  • When it is important to consult and/or remain in close

contact with physician

  • When it is important to seek emergency care
claritin otc consumer and health professional education program78
Claritin® OTCConsumer and Health Professional Education Program

Potential Delivery Platforms

  • Internet web site with links to:
    • AAAAI Allergy Report
    • AAD Web Site
    • WebMD
    • Mayo Clinic
  • 1-800#
  • In-Store Programs
  • Direct Mail

Health Professional Support

  • Pharmacist CE Programs
  • School Nurse CE Programs
response to fda questions
Response to FDA Questions
  • Data support accurate self-selection of consumers following physician diagnosis
    • Physicians and CIU sufferers conclude patients can self-recognize recurrent episodes
    • Self recognition study demonstrates accurate self recognition following initial diagnosis
  • Labeling for Claritin® can be developed for proper OTC use for CIU
slide80

OTC Migraine Label

Ask a doctor before use if you have never had migraines diagnosed by a health professional

conclusions81
Conclusions
  • OTC labeling and a consumer education program will facilitate proper use by urticaria sufferers and encourage appropriate medical consultation when warranted
    • OTC antihistamines currently used for hives without label instructions and precautions
    • Misuse for acute hives is low risk
    • Label instructions and consumer education program will encourage proper care
advisory committee questions
Advisory Committee Questions

1. Is urticaria a disease process appropriate for an OTC indication?

If yes, should the indication be for chronic idiopathic urticaria (CIU)/hives or should it be broader such that it includes acute urticaria/hives?

advisory committee questions83
Advisory Committee Questions

2. If your answer to Question 1 is “yes,” are there sufficient data to support an OTC switch of loratadine for CIU or a more general urticaria claim.

If not, what other types of data are needed (such as clinical trial(s) for efficacy, safety label comprehension, or actual use)?

advisory committee questions84
Advisory Committee Questions

3. If your answer to Question 2 is “yes,” what are your recommendations for appropriate labeling of loratadine, with regard to indications, warnings, and directions.

recommendation
Recommendation

Claritin® is an appropriate, safe and effective therapy for treating symptoms of previously diagnosed chronic idiopathic urticaria in an OTC setting.