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Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With

Ailsa Hart1, Seyedehsan Navabi2, Geert D'Haens3

  • 1St Mark's Hospital & Imperial College London, London, UK.

United European Gastroenterology Journal
|May 9, 2026
PubMed
Abstract

Insights

Mirikizumab shows efficacy in ulcerative colitis patients, even those with prior advanced therapy failure (PATF). This includes patients with difficult-to-treat (DTT) disease, demonstrating consistent treatment benefits.

Area of Science:

  • Gastroenterology
  • Immunology
  • Clinical Pharmacology

Background:

  • Ulcerative colitis (UC) is a chronic inflammatory bowel disease requiring effective treatments.
  • Mirikizumab has shown efficacy in moderately-to-severely active UC.
  • Prior advanced therapy failure (PATF) is common in UC patients, necessitating analysis of treatment efficacy in this population.

Purpose of the Study:

  • To evaluate the efficacy of mirikizumab in patients with moderately-to-severely active ulcerative colitis based on the number and mechanism of prior advanced therapy failures (PATF).
  • To assess mirikizumab's effectiveness in difficult-to-treat (DTT) UC subgroups.

Main Methods:

  • Post hoc analysis of data from the Phase 3 LUCENT-1 and LUCENT-2 trials.
  • Patients received mirikizumab induction and maintenance therapy.
  • Efficacy was analyzed in subgroups based on PATF number (0, 1, ≥2) and mechanism (including DTT: anti-TNF plus tofacitinib and/or vedolizumab).

Main Results:

  • At week 12, clinical response rates varied by PATF status: 69.8% (0 PATF), 63.9% (1 PATF), 45.3% (≥2 PATF), and 41.9% (DTT subgroup).
  • At week 52, clinical remission rates among week 12 responders were 51.9% (0 PATF), 44.2% (1 PATF), 49.0% (≥2 PATF), and 42.9% (DTT subgroup).
  • In the extended induction population, clinical response at week 24 was observed in 62.4% (0 PATF), 41.4% (1 PATF), 49.5% (≥2 PATF), and 49.3% (DTT subgroup).

Conclusions:

  • Mirikizumab demonstrates efficacy in inducing and maintaining clinical response and remission in patients with moderately-to-severely active ulcerative colitis.
  • Treatment efficacy is consistent across patients with varying numbers of prior advanced therapy failures, including those with difficult-to-treat disease.
  • Mirikizumab offers a valuable therapeutic option for UC patients who have previously failed other advanced therapies.
Keywords:
advanced therapybiologicdifficult‐to‐treatmirikizumabulcerative colitis

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