Urticaria – Unmet Need – Detailed, Expanded Analysis (US & EU) Chronic Inducible Urticaria And Chronic Spontaneous Urticaria
Treatment of chronic spontaneous and chronic inducible urticaria is dominated by oral medications—both approved (e.g., first- and second-generation antihistamines) and off-label (e.g., DMARDs, immunosuppressants, tricyclic antidepressants). However, several of these drug classes can have serious side effects, and many patients still struggle to control their lesions. Novartis / Roche’s Xolair is the first and only FDA-approved biologic for chronic spontaneous urticaria, although other biologics are used off-label. Clinical trials of additional biological therapies are under way, but with only one biologic approved for chronic urticaria, the factors that can positively differentiate emerging drugs from current therapies remain unknown, and many unmet needs in this space remain unfulfilled.
Questions answered
- Following the approval of Xolair, what unmet needs remain in the treatment of chronic urticaria?
- Which clinical trial endpoints and nonclinical attributes are key influencers of dermatologists’ and allergists’ prescribing decisions, and which have limited impact? What are areas of hidden opportunity?
- How does Xolair perform on key treatment drivers and goals? How does its performance compare with that of frequently prescribed conventional therapies, including immunosuppressants and antihistamines?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European dermatologists and allergists for a hypothetical new chronic urticaria drug?
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. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.
Markets covered: United States, France, Germany, United Kingdom
Primary research: Survey of 60 U.S. and 31 European dermatologists and allergists fielded in March 2022
Key companies: Novartis, Roche, Sanofi, Regeneron
Key drugs: Xolair, Dupixent, antihistamines, immunosuppressants
Content highlights: 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
Table of contents
- Urticaria - Unmet Need - Detailed, Expanded Analysis (US & EU) Chronic Inducible Urticaria And Chronic Spontaneous Urticaria
- Executive summary
- Unmet Need - chronic urticaria - executive summary - May 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for chronic urticaria and rationale for drug selection
- 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 chronic urticaria
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed allergists' prescribing decisions in chronic urticaria
- Importance of efficacy attributes to dermatologists' prescribing decisions in chronic urticaria: United States
- Importance of efficacy attributes to allergists' prescribing decisions in chronic urticaria: United States
- Importance of efficacy attributes to dermatologists' prescribing decisions in chronic urticaria: Europe
- Importance of efficacy attributes to allergists' prescribing decisions in chronic urticaria: Europe
- Importance of safety and tolerability attributes to dermatologists' prescribing decisions in chronic urticaria: United States
- Importance of safety and tolerability attributes to allergists' prescribing decisions in chronic urticaria: United States
- Importance of safety and tolerability attributes to dermatologists' prescribing decisions in chronic urticaria: Europe
- Importance of safety and tolerability attributes to allergistsu2019 prescribing decisions in chronic urticaria: Europe
- Importance of convenience of administration attributes to dermatologists' prescribing decisions in chronic urticaria: United States
- Importance of convenience of administration attributes to allergists' prescribing decisions in chronic urticaria: United States
- Importance of convenience of administration attributes to dermatologists' prescribing decisions in chronic urticaria: Europe
- Importance of convenience of administration attributes to allergists' prescribing decisions in chronic urticaria: Europe
- Importance of nonclinical factors to dermatologists' prescribing decisions in chronic urticaria: United States
- Importance of nonclinical factors to allergists' prescribing decisions in chronic urticaria: United States
- Importance of nonclinical factors to dermatologists' prescribing decisions in chronic urticaria: Europe
- Importance of nonclinical factors to allergists' prescribing decisions in chronic urticaria: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to dermatologists' prescribing decisions in chronic urticaria: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to allergists' prescribing decisions in chronic urticaria: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to dermatologists' prescribing decisions in chronic urticaria: Europe
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to allergists' prescribing decisions in chronic urticaria: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for chronic urticaria: U.S. dermatologists
- Overall performance of key therapies for chronic urticaria: U.S. allergists
- Overall performance of key therapies for chronic urticaria: European dermatologists
- Overall performance of key therapies for chronic urticaria: European allergists
- Mean overall performance of key therapies for chronic urticaria: U.S. and European dermatologists
- Mean overall performance of key therapies for chronic urticaria: U.S. and European allergists
- Relative performance of key therapies for chronic urticaria across select efficacy attributes: U.S. dermatologists
- Relative performance of key therapies for chronic urticaria across select efficacy attributes: U.S. allergists
- Relative performance of key therapies for chronic urticaria across select efficacy attributes: European dermatologists
- Relative performance of key therapies for chronic urticaria across select efficacy attributes: European allergists
- Relative performance of key therapies for chronic urticaria across select safety and tolerability attributes: U.S. dermatologists
- Relative performance of key therapies for chronic urticaria across select safety and tolerability attributes: U.S. allergists
- Relative performance of key therapies for chronic urticaria across select safety and tolerability attributes: European dermatologists
- Relative performance of key therapies for chronic urticaria across select safety and tolerability attributes: European allergists
- Relative performance of key therapies for chronic urticaria across select convenience of administration attributes: U.S. dermatologists
- Relative performance of key therapies for chronic urticaria across select convenience of administration attributes: U.S. allergists
- Relative performance of key therapies for chronic urticaria across select convenience of administration attributes: European dermatologists
- Relative performance of key therapies for chronic urticaria across select convenience of administration attributes: European allergists
- Relative performance of key therapies for chronic urticaria across select nonclinical attributes: U.S. dermatologists
- Relative performance of key therapies for chronic urticaria across select nonclinical attributes: U.S. allergists
- Relative performance of key therapies for chronic urticaria across select nonclinical attributes: European dermatologists
- Relative performance of key therapies for chronic urticaria across select nonclinical attributes: European allergists
- Assessment of unmet need
- Key findings: unmet need in chronic urticaria
- Surveyed dermatologistsu2019 satisfaction with the performance of key therapies for chronic urticaria on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed allergistsu2019 satisfaction with the performance of key therapies for chronic urticaria on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed dermatologistsu2019 satisfaction with the performance of key therapies for chronic urticaria on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed allergistsu2019 satisfaction with the performance of key therapies for chronic urticaria on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed dermatologists' ascribed level of unmet need across key efficacy attributes in chronic urticaria: United States
- Surveyed allergists' ascribed level of unmet need across key efficacy attributes in chronic urticaria: United States
- Surveyed dermatologists' ascribed level of unmet need across key efficacy attributes in chronic urticaria: Europe
- Surveyed allergists' ascribed level of unmet need across key efficacy attributes in chronic urticaria: Europe
- Surveyed dermatologists' ascribed level of unmet need across key safety and tolerability attributes in chronic urticaria: United States
- Surveyed allergists' ascribed level of unmet need across key safety and tolerability attributes in chronic urticaria: United States
- Surveyed dermatologists' ascribed level of unmet need across key safety and tolerability attributes in chronic urticaria: Europe
- Surveyed allergists' ascribed level of unmet need across key safety and tolerability attributes in chronic urticaria: Europe
- Surveyed dermatologists' ascribed level of unmet need across key convenience of administration attributes in chronic urticaria: United States
- Surveyed allergists' ascribed level of unmet need across key convenience of administration attributes in chronic urticaria: United States
- Surveyed dermatologists' ascribed level of unmet need across key convenience of administration attributes in chronic urticaria: Europe
- Surveyed allergists' ascribed level of unmet need across key convenience of administration attributes in chronic urticaria: Europe
- Surveyed dermatologists' ascribed level of unmet need across key nonclinical factors in chronic urticaria: United States
- Surveyed allergists' ascribed level of unmet need across key nonclinical factors in chronic urticaria: United States
- Surveyed dermatologists' ascribed level of unmet need across key nonclinical factors in chronic urticaria: Europe
- Surveyed allergists' ascribed level of unmet need across key nonclinical factors in chronic urticaria: Europe
- Key findings: unmet need in chronic urticaria and related indications
- Surveyed dermatologists' ascribed level of unmet need in chronic urticaria and related indications: United States
- Surveyed allergists' ascribed level of unmet need in chronic urticaria and related indications: United States
- Surveyed dermatologists' ascribed level of unmet need in chronic urticaria and related indications: Europe
- Surveyed allergists' ascribed level of unmet need in chronic urticaria and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the chronic urticaria market and emerging therapy insights
- Opportunity: A therapy delivering quality-of-life improvements
- Opportunity: A therapy that reduces urticaria activity
- Opportunity: A therapy that can induce remission
- Areas of opportunity in the chronic urticaria market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attributes of key current and late-phase emerging therapies for chronic urticaria
- Attribute importance and part-worth utilities
- Chronic urticaria target product profile: attribute importance
- Absolute improvement in DLQI (Dermatology Life Quality Index)
- Absolute decrease in weekly ISS (Itch Severity Score)
- Absolute decrease in UAS7 (Urticaria Activity Score, 7 days)
- Time to minimally important difference in ISS
- Percentage of patients achieving remission within 12 weeks
- Risk of serious adverse events (%, placebo-adjusted)
- Price per day (USD)
- Conjoint analysis-based simulation of a market scenario
- Chronic urticaria market simulation: share of preference of target product profiles included in the market scenario
- Chronic urticaria market simulation: likelihood to prescribe target product profiles included in the market scenario
- Chronic urticaria market simulation: target product profiles included in the market scenario
- Executive summary
Shubhendu Ghosh, Ph.D., is a senior business insights analyst on the Immune and Inflammatory Disorders team at Clarivate. His focus is the asthma therapy market. Previously, Dr. Ghosh was an associate editor at Nature Structural & Molecular Biology and a copy editor at Nature Medicine. He was also a scientific and developmental editor at Nature Research Editing Service. He holds a Ph.D. in biomedical sciences from the University of Massachusetts Medical School, a B.Sc. in microbiology from Delhi University, and an M.Sc. in biotechnology from Madurai Kamaraj University.