The management of pediatric patients with moderate to severe atopic dermatitis (AD) is poised for transformation. Sanofi/Regeneron’s Dupixent, on the heels of a positive Phase III study in adolescent patients, appears set to gain expanded approval in this population beginning in 2019, and the late-stage pipeline features compelling programs, including Pfizer’s abrocitinib and AbbVie’s upadacitinib. Pediatric patients comprise a sizable percentage of the AD population, and clinicians appear to manage them with a risk tolerance that is lower than accepted in adult patients. We will assess the commercial opportunity in the pediatric, topical-refractory, moderate to severe AD space through a comprehensive look at the key efficacy, safety, and delivery attributes driving prescribing choice; the gaps in treatment left by current therapies; and the interplay of clinical and nonclinical attributes in determining the appeal of potential AD products in the pediatric population.

QUESTIONS ANSWERED

  • How do surveyed dermatologists rate the performance of current therapies (e.g., Sanofi/Regeneron’s Dupixent, cyclosporine) on attributes including effect on eczema, effect on itch, safety/tolerability, delivery, and nonclinical factors?
  • What are the most compelling unmet treatment needs that would drive positive differentiation in this arena (e.g., fast onset of action)? How well poised are pipeline agents (e.g., Pfizer’s abrocitinib, AbbVie’s upadacitinib) to capitalize on them?
  • What trade-offs between clinical attributes and price will clinicians accept when considering whether to prescribe a hypothetical AD target product profile?

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 30 European dermatologists treating pediatric patients

Key companies: Sanofi, Regeneron, Pfizer, AbbVie, LEO Pharma, Eli Lilly, Incyte, Vanda, Novartis, Galderma, Dermira

Key drugs: Dupixent, cyclosporine, methotrexate, azathioprine, mycophenolate, oral prednisone

KEY METRICS INCLUDED

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology
  • Stated versus derived importance of product attributes on prescribing behavior
  • Assessment of current drug performance against treatment drivers and goals
  • Physician perceptions of unmet needs in the indication and related indications
  • Analysis of remaining
  • Drug development opportunities

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Table of contents

  • Atopic Dermatitis/Atopic Eczema - Unmet Need - Detailed, Expanded Analysis: Pediatric (US & EU)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for Atopic Dermatitis
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Dermatologists' Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis
      • Importance of Efficacy Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Key Findings: Stated vs. Derived Importance
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Overall Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Mean Overall Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States and Europe
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis
      • Surveyed Dermatologists’ Satisfaction with the Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Dermatologists’ Satisfaction with the Performance of Key Therapies for Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: United States
      • Surveyed Dermatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis: Europe
      • Key Findings: Unmet Need in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis and Related Indications
      • Surveyed Dermatologists' Ascribed Level of Unmet Need in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis and Related Indications: United States
      • Surveyed Dermatologists' Ascribed Level of Unmet Need in Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Topical Refractory, Moderate to Severe Pediatric Atopic Dermatitis Market and Emerging Therapy Insights
        • Opportunity: Therapies That Are More Effective in Clearing Eczema
        • Opportunity: Therapies That Are More Effective in Reducing Itch
        • Opportunity: Additional Effective Therapies That Have Good Safety and Tolerability Profiles
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • Attribute Importance and Part-Worth Utilities
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Target Product Profile: Attribute Importance
        • Percentage of Patients Achieving IGA of 0-1
        • Percentage Improvement from Baseline in Pruritus NRS at Week 16 (Monotherapy)
        • EASI-75 Responder Rate at Week 16 (Monotherapy)
        • Percentage of Patients Improving ≥ Four Points on Pruritus NRS at Week 2 (Monotherapy)
        • Delivery Burden (Route of Administration and Dosing Frequency)
        • Percentage of Patients with Noncutaneous Infectious Adverse Events at Week 16
        • Price per Treated Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Target Product Profiles Included in Scenario 1
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Topical-Refractory Moderate to Severe Pediatric Atopic Dermatitis Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Laura Darnieder

Laura Darnieder is a Business Insights Analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, where she is focused on providing market forecasts within the niche biopharmaceutical space.

Prior to joining DRG, Laura earned a Ph.D. in Neuroscience from Tufts University Sackler School of Graduate Biomedical Sciences. Her research focused on the role of stress neuropeptides and inhibitory signaling in alcohol dependence and drug addiction. She also holds a B.S., summa cum laude, in Psychobiology and Linguistics from Binghamton University (SUNY).