Ulcerative Colitis – Unmet Need – Detailed, Expanded Analysis: Moderate To Severe Ulcerative Colitis (US/EU)
Tumor necrosis factor (TNF)-alpha inhibitors (e.g., Janssen’s Remicade, AbbVie’s Humira, biosimilars of both drugs, where available) and a cell adhesion molecule (CAM) inhibitor (Takeda’s Entyvio) are the mainstays of biological treatment for moderate to severe ulcerative colitis (UC). However, these agents have efficacy limitations. Additionally, TNF-alpha inhibitors carry safety warnings. Pfizer’s Xeljanz / Xeljanz XR, Galapagos’s Jyseleca (only in Europe), AbbVie’s Rinvoq (oral Janus-activated kinase [JAK] inhibitors), 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 currently available agents, significant unmet need exists, especially for patients refractory to these therapies. Although several agents in late-phase development (including additional JAK inhibitors and S1P-R modulators as well as molecules with novel MOAs [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 for moderate to severe UC?
- How do TNF-α inhibitors (branded and biosimilars) and other targeted therapies (e.g., Entyvio, Stelara, Zeposia, Xeljanz / Xeljanz XR, Rinvoq) perform on key 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 moderate to severe UC?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European gastroenterologists for a hypothetical new UC 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, United Kingdom, France, Germany.
Primary research: Survey of 62 U.S. and 32 European gastroenterologists fielded in February 2023.
Key companies: AbbVie, Janssen, Pfizer, Takeda, UCB, BMS.
Key drugs: Humira, Remicade, Entyvio, Xeljanz, Stelara, Zeposia, Rinvoq, adalimumab biosimilars, infliximab biosimilars.
Table of contents
- Ulcerative Colitis - Unmet Need - Detailed, Expanded Analysis: Moderate To Severe Ulcerative Colitis (US/EU)
- Executive summary
- Unmet Need - moderate to severe ulcerative colitis - executive summary - May 2023
- 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 gastroenterologistsu2019 ascribed level of unmet need across key efficacy attributes in moderate to severe UC: United States
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key efficacy attributes in moderate to severe UC: Europe
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key safety and tolerability attributes in moderate to severe UC: United States
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key safety and tolerability attributes in moderate to severe UC: Europe
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key convenience of administration attributes in moderate to severe UC: United States
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key convenience of administration attributes in moderate to severe UC: Europe
- Surveyed gastroenterologistsu2019 ascribed level of unmet need across key nonclinical factors in moderate to severe UC: United States
- Surveyed gastroenterologistsu2019 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 gastroenterologistsu2019 ascribed level of unmet need in moderate to severe UC and related indications: United States
- Surveyed gastroenterologistsu2019 ascribed level of unmet need in moderate to severe UC and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the moderate to severe UC market and emerging therapy insights
- Opportunity: a novel therapy demonstrating a greater effect on long-term maintenance of remission
- Opportunity: a novel therapy that improves corticosteroid-free remission rates
- Opportunity: a novel oral therapy offering improved safety
- Areas of opportunity in the moderate to severe 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 6-12 weeks (% of patients, placebo-adjusted)
- Maintenance of remission at 52-58 weeks (% of patients, placebo-adjusted)
- Mucosal healing at 52-58 weeks (% of patients, placebo-adjusted)
- Corticosteroid-free remission at 52-58 weeks (% of patients, placebo-adjusted)
- Incidence of serious adverse events at 52-58 weeks (% 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 of 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
Swati Kinger, M.B.A., Healthcare Research & Data Analyst, Immune and Inflammation. Ms. Kinger’s focus is the axial spondyloarthritis market. Previously, she was an associate consultant for a life sciences firm, where she worked on syndicated offerings and ad-hoc requests involving patient journeys, market assessment, and competitive intelligence. She holds a bachelor’s degree in pharmacy from Delhi University and an M.B.A. in pharmacy from the National Institute of Pharmaceutical Education and Research in India.