Reaching Comprehensive Disease Control in UC, With Stefan Schreiber, MD

Among patients with moderately to severely active ulcerative colitis who responded to mirikizumab (Omvoh) induction, 27.7% reached comprehensive disease control (CDC) at week 52, compared with 14.0% of patients who switched to placebo. The findings are from a post hoc analysis of the phase 3 LUCENT-1 and LUCENT-2 trials presented at United European Gastroenterology (UEG) Week 2026, held October 17 to 20 in Barcelona, Spain.¹

Among patients without prior biologic failure, 30.0% reached CDC with mirikizumab.

“This is remarkable if you consider that it means one out of three bio-naive patients will have their disease completely shut down by the therapy,” Stefan Schreiber, MD, of the Department of Internal Medicine at University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel, in Germany, said in an interview with HCPLive. “It’s not healed, obviously, because you cannot stop the therapy, but it’s completely controlled.”

How the LUCENT CDC Analysis Was Designed

Mirikizumab, an interleukin (IL)-23p19 antagonist, was approved by the US Food and Drug Administration (FDA) for moderately to severely active ulcerative colitis in October 2023, based on the LUCENT program.²

In the moderated poster, “Mirikizumab Therapy Enables Comprehensive Disease Control with Improved Quality of Life in Patients with Moderately-to-Severely Active Ulcerative Colitis: A Post-Hoc Analysis of Phase 3 LUCENT-1 and LUCENT-2 Trials,” Schreiber and colleagues evaluated CDC at week 52 using a definition informed by an international Delphi consensus in inflammatory bowel disease (IBD).¹ ³

CDC required all of the following:

• Clinical remission
• No corticosteroid use for ≥12 weeks
• Histologic remission
• Fecal calprotectin ≤250 μg/g

A second definition added Inflammatory Bowel Disease Questionnaire (IBDQ) remission, a total score ≥170.¹

The analysis included 544 patients who responded to 12 weeks of intravenous mirikizumab induction. They were rerandomized 2:1 to continue subcutaneous mirikizumab 200 mg (n = 365) or switch to placebo (n = 179) every 4 weeks.¹

Mirikizumab CDC Rates at Week 52

Overall, 27.7% of patients receiving mirikizumab reached CDC at week 52, compared with 14.0% receiving placebo (P = .002). Among patients without prior biologic failure, rates were 30.0% vs 16.5% (P = .027), and among those with prior biologic failure, 23.4% vs 9.4% (P = .019).¹

When IBDQ remission was added to the definition, 25.2% of patients receiving mirikizumab reached CDC, compared with 12.3% receiving placebo (P = .002).¹

Among patients without prior biologic failure, disease duration was the only baseline characteristic with a significant difference. With IBDQ remission included, 32.2% of patients with ulcerative colitis for <7 years reached CDC, compared with 18.2% of those with ulcerative colitis for ≥7 years.¹

CDC Associated With IBDQ Quality of Life Remission

Among patients treated with mirikizumab, 91.1% of those who reached CDC also reached IBDQ remission, compared with 65.2% of those who did not (P <.001).¹

Because most patients who reached CDC were already in quality of life remission, adding IBDQ remission to the definition lowered CDC rates only slightly, from 27.7% to 25.2%.¹

“If you have achieved the morphologic and symptom-based parameters in this combined endpoint, you have also regained your quality of life,” Schreiber said. “Adding quality of life remission on top of that doesn’t sharpen your endpoint any further.”

Editors’ Note: Disclosures for Schreiber include AbbVie, Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Dr Falk Pharma, Ferring, Fresenius, Galapagos, Genentech, GSK, Gilead, I-MAB Biopharma, Janssen, Lilly, Merck, Novartis-Sandoz, Pfizer, Protagonist, Takeda and Theravance.

References

1. Schreiber S, Magro F, Danese S, et al. Mirikizumab therapy enables comprehensive disease control with improved quality of life in patients with moderately-to-severely active ulcerative colitis: a post-hoc analysis of phase 3 LUCENT-1 and LUCENT-2 trials. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain.

2. D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940

3. Schreiber S, Danese S, Dignass A, et al. Defining comprehensive disease control for use as a treatment target for ulcerative colitis in clinical practice: international Delphi consensus recommendations. J Crohns Colitis. 2024;18(1):91-105. doi:10.1093/ecco-jcc/jjad130