Mirikizumab Deep Remission in Crohn’s Disease, With Stefan Schreiber, MD

About 1 in 5 patients with moderately to severely active Crohn’s disease treated with mirikizumab (Omvoh) reached corticosteroid-free deep remission at 1 year, according to a post hoc analysis of the phase 3 VIVID-1 trial presented at United European Gastroenterology (UEG) Week 2026, held October 17 to 20 in Barcelona, Spain. Rates were greater among patients without prior biologic failure, and nearly 90% of patients who reached deep remission also reached quality of life remission.¹

“In practical terms, it means that within the non-bio-failed population, one out of four patients has a completely stopped disease,” 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. “The disease is not healed, because you still have to treat the patient, but it is under complete control.”

Deep Remission as a Crohn’s Disease Treatment Target

The field of inflammatory bowel disease (IBD) is moving toward composite treatment targets that combine symptoms, endoscopy and biomarkers. The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) consensus recommends deep remission, the combination of clinical and endoscopic remission, as a key target in Crohn’s disease.¹

Deep remission has typically been measured with the Crohn’s Disease Activity Index (CDAI), which includes patient-reported and clinical variables. Whether a symptom-only patient-reported outcome (PRO) definition captures deep remission comparably had not been well characterized.¹

Schreiber noted that, unlike comprehensive disease control in ulcerative colitis, deep remission in Crohn’s disease does not yet include histology. VIVID-1 is the only trial so far to have used histology as an endpoint, and that finding has not yet been replicated.

Mirikizumab, an interleukin (IL)-23p19 antagonist, was approved by the US Food and Drug Administration (FDA) for moderately to severely active Crohn’s disease in January 2025, based on VIVID-1 results.²

VIVID-1 Analysis Compared PRO and CDAI Deep Remission

In the moderated poster, “Mirikizumab Effect on Deep Remission with Improved Quality of Life in Moderately to Severely Active Crohn’s Disease: A Post Hoc Analysis from VIVID-1,” Schreiber and colleagues assessed deep remission with 2 definitions.¹

CDAI deep remission was corticosteroid-free CDAI remission (CDAI <150) plus endoscopic remission (Simple Endoscopic Score for Crohn’s Disease [SES-CD] ≤4, a ≥2-point reduction from baseline and no subscore >1). PRO deep remission required stool frequency ≤3 and abdominal pain ≤1, neither worse than baseline, plus endoscopic remission.¹

Treat through endpoints required corticosteroid-free clinical remission through week 52 and endoscopic remission at week 52. The analysis included 579 patients receiving mirikizumab and 199 receiving placebo. IBDQ remission was defined as an Inflammatory Bowel Disease Questionnaire total score ≥170.¹

Steroid-Free Deep Remission Rates at Week 52

At week 52, 20.6% of patients receiving mirikizumab reached PRO deep remission and 20.4% reached CDAI deep remission, compared with 1.5% and 2.0% of patients receiving placebo (both P <.001). Composite endpoints, which also required a PRO-based clinical response at week 12, were consistent: 18.5% and 18.0% with mirikizumab vs 1.5% and 2.0% with placebo.¹

Rates were greater among patients with no prior biologic failure (25.5%) than among those with prior biologic failure (15.3%). Among patients without prior biologic failure, 29.0% of those with a disease duration <5 years reached PRO deep remission, compared with 19.8% of those with a duration ≥5 years. The investigators wrote that this underscores “the importance of earlier intervention in the disease course.”¹

Deep Remission Associated With IBDQ Quality of Life Remission

Among patients treated with mirikizumab, 87.4% of those who reached PRO deep remission also reached IBDQ remission, compared with 51.1% of those who did not (P <.001). Results were similar for the CDAI definition (88.1% vs 51.0%; P <.001).¹

“We think this is a highly relevant endpoint for optimizing future therapeutic development in IBD,” Schreiber said. “We think it should be implemented in clinical trials, also in prospective settings, and should lead us to further optimize patient care in Crohn’s disease.”

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, Rubin DT, Magro F, et al. Mirikizumab effect on deep remission with improved quality of life in moderately to severely active Crohn’s disease: a post hoc analysis from VIVID-1. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain.

2. Ferrante M, D’Haens G, Jairath V, et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436.