Ulcerative Colitis – Unmet Need – Detailed, Expanded Analysis (US & EU)
Tumor necrosis factor (TNF)-alpha inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira, biosimilars of both drugs where available) are the mainstay of biological treatment for moderate to severe ulcerative colitis (UC). However, these agents carry safety risks and have efficacy limitations. Takeda’s Entyvio (a cell adhesion molecule [CAM] inhibitor), Pfizer’s Xeljanz / Xeljanz XR (an oral Janus-activated kinase [JAK] inhibitor), Janssen’s Stelara (an interleukin [IL]-12/23 inhibitor), and BMS’s Zeposia (an oral S1P-R modulator) have expanded the treatment options for moderate to severe UC, but despite the number of available agents, significant unmet need remains, especially for patients refractory to these therapies. Although several agents in late-phase development (including additional JAK inhibitors and S1P-R modulators and molecules with novel mechanisms of action [e.g., IL-23 inhibitors]) are poised to enter the moderate to severe UC market over the next several years, their ability to fulfill these unmet needs remains to be seen.
QUESTIONS ANSWERED
- What are the treatment drivers and goals in moderate to severe UC?
- How do TNF-α inhibitors (branded and biosimilars) and other targeted therapies (i.e., Entyvio, Stelara, Zeposia, and Xeljanz / Xeljanz XR) perform on treatment drivers and goals?
- In addition to efficacy, what other drug attributes influence physician prescribing behavior the most, and which attributes have a limited impact?
- What are the prevailing areas of unmet need and hidden opportunity in the treatment of moderate to severe UC?
- What trade-offs in terms of clinical attributes and price are acceptable to U.S. and European gastroenterologists for a hypothetical new UC drug?
PRODUCT DESCRIPTION
Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 61 U.S. and 31 European gastroenterologists fielded in February 2022
Key companies: AbbVie, Janssen, Takeda, Pfizer, Eli Lilly, Bristol Myers Squibb, Celltrion Healthcare
Key drugs: Humira, adalimumab biosimilar, Remicade, infliximab biosimilar (IV), Remsima SC, Entyvio, Xeljanz / Xeljanz XR, Stelara, Zeposia, Rinvoq, Jyseleca
Table of contents
- Ulcerative Colitis - Unmet Need - Detailed, Expanded Analysis (US & EU)
- Executive summary
- Unmet Need - moderate to severe UC - Executive summary - May 2022
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for moderate to severe UC 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 gastroenterologists' prescribing decisions in moderate to severe UC
- Importance of efficacy attributes to prescribing decisions in moderate to severe UC: United States
- Importance of efficacy attributes to prescribing decisions in moderate to severe UC: Europe
- Importance of safety and tolerability attributes to prescribing decisions in moderate to severe UC: United States
- Importance of safety and tolerability attributes to prescribing decisions in moderate to severe UC: Europe
- Importance of convenience of administration attributes to prescribing decisions in moderate to severe UC: United States
- Importance of convenience of administration attributes to prescribing decisions in moderate to severe UC: Europe
- Importance of nonclinical factors to prescribing decisions in moderate to severe UC: United States
- Importance of nonclinical factors to prescribing decisions in moderate to severe UC: 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 moderate to severe UC: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in moderate to severe UC: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for moderate to severe UC: United States
- Overall performance of key therapies for moderate to severe UC: Europe
- Mean overall performance of key therapies for moderate to severe UC: United States and Europe
- Relative performance of key therapies for moderate to severe UC across select efficacy attributes: United States
- Relative performance of key therapies for moderate to severe UC across select efficacy attributes: Europe
- Relative performance of key therapies for moderate to severe UC across select safety and tolerability attributes: United States
- Relative performance of key therapies for moderate to severe UC across select safety and tolerability attributes: Europe
- Relative performance of key therapies for moderate to severe UC across select convenience of administration attributes: United States
- Relative performance of key therapies for moderate to severe UC across select convenience of administration attributes: Europe
- Relative performance of key therapies for moderate to severe UC across select nonclinical attributes: United States
- Relative performance of key therapies for moderate to severe UC across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in moderate to severe UC
- Surveyed gastroenterologistsu2019 satisfaction with the performance of key therapies for moderate to severe UC on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed gastroenterologistsu2019 satisfaction with the performance of key therapies for moderate to severe UC on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed gastroenterologists' ascribed level of unmet need across key efficacy attributes in moderate to severe UC: United States
- Surveyed gastroenterologists' ascribed level of unmet need across key efficacy attributes in moderate to severe UC: Europe
- Surveyed gastroenterologists' ascribed level of unmet need across key safety and tolerability attributes in moderate to severe UC: United States
- Surveyed gastroenterologists' ascribed level of unmet need across key safety and tolerability attributes in moderate to severe UC: Europe
- Surveyed gastroenterologists' ascribed level of unmet need across key convenience of administration attributes in moderate to severe UC: United States
- Surveyed gastroenterologists' ascribed level of unmet need across key convenience of administration attributes in moderate to severe UC: Europe
- Surveyed gastroenterologists' ascribed level of unmet need across key nonclinical factors in moderate to severe UC: United States
- Surveyed gastroenterologists' ascribed level of unmet need across key nonclinical factors in moderate to severe UC: Europe
- Key findings: unmet need in moderate to severe UC and related indications
- Surveyed gastroenterologists' ascribed level of unmet need in moderate to severe UC and related indications: United States
- Surveyed gastroenterologists' ascribed level of unmet need in moderate to severe UC and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the UC market and emerging therapy insights
- Opportunity: a novel therapy demonstrating greater effect on long-term maintenance of remission
- Opportunity: a novel therapy that improves mucosal healing rates
- Opportunity: a novel therapy that improves corticosteroid-free remission rates
- Opportunity: a novel oral therapy offering improved safety
- Areas of opportunity in the UC market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Attribute importance and part-worth utilities
- Moderate to severe UC target product profile: attribute importance
- Induction of remission at 8 weeks (% of patients, placebo-adjusted)
- Maintenance of remission at 52 weeks (% of patients, placebo-adjusted)
- Mucosal healing at 52 weeks (% of patients, placebo-adjusted)
- Corticosteroid-free remission at 52 weeks (% of patients, placebo-adjusted)
- Incidence of serious adverse events (% of patients, placebo-adjusted)
- Delivery burden (dosing formulation and frequency, UC maintenance setting)
- Price per treated day (UC maintenance setting)
- Conjoint analysis-based simulation of a market scenario
- Moderate to severe UC market simulation: share of preference of target product profiles included in the market scenario
- Moderate to severe UC market simulation: likelihood to prescribe target product profiles included in the market scenario
- Moderate to severe UC market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Experts interviewed
- Bibliography
- Executive summary
Ritesh Gupta, Ph.D., is a manager in the Immune and Inflammatory Disorders team at Clarivate. He has years of experience in competitive intelligence, scientific analysis, and market opportunity assessment and has worked in various therapeutic areas to provide strategic recommendations to pharmaceutical companies. He holds a Ph.D. in cell biology from the Max Delbrück Center for Molecular Medicine in Berlin.