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

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