3-Year Efficacy, Safety of Mirikizumab in Crohn’s Disease: Insights From VIVID-2, With Edward Barnes, MD, MPH

Long-term durability remains one of the central questions in the management of moderate-to-severe Crohn’s disease. While many advanced therapies demonstrate strong induction and shorter-term maintenance data, clinicians often grapple with whether those benefits persist and whether safety signals emerge with longer exposure.

New 3-year results from the ongoing VIVID-2 extension study offer important insight into the sustained efficacy and safety of mirikizumab, a selective IL-23p19 monoclonal antibody that earned US Food and Drug Administration approval for Crohn’s in January 2025 based on positive results from the phase 3 VIVID-1 study in adults with moderately to severely active Crohn’s who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics.

In an interview with HCPLive, Edward Barnes, MD, MPH, an associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill, explained how the IL-23 class has generated significant enthusiasm in recent years because of its combination of robust efficacy and a favorable safety profile.

“What differentiates them is what I would consider an efficacy signal, meaning that it's effective in the treatment of Crohn's disease, but also combined with the safety signal. I think that is really attractive when you think about some of our more traditional therapies, which certainly have worked very well, but sometimes patients have concerns about potential long term adverse effects, or even in the short term as well, in terms of infectious complications or long term risks,” he explained. “I always tell my patients that all of our therapies are way more safe than having uncontrolled disease, but I think that's what really stands out when you think about the anti-interleukin 23 mechanism, which mirikizumab falls into.”

The VIVID-2 data extend outcomes to 3 years in patients who achieved endoscopic response at week 52 in the phase 3 VIVID-1 trial and continued mirikizumab maintenance therapy. Sustained remission rates were notable, including durable clinical remission and corticosteroid-free remission through week 152. The latter, Barnes stressed, is particularly critical.

Of note, durability was not limited to early responders. A subgroup of patients who were endoscopic nonresponders at week 52 underwent reinduction and demonstrated meaningful gains over time, with roughly 60% achieving clinical and corticosteroid-free remission by year three.

Patient-centered outcomes also remained a focus, with improvements in bowel urgency sustained through 3 years.

“I think bowel urgency is really important when we think about IBD in general,” Barnes said. “Urgency is a type of symptom that will keep patients from living the kind of life that they want to live… Finding a way to actually capture a clinically meaningful response in terms of urgency is critical, and so to be able to actually show that in an objective way, with the urgency numeric rating score in these data, is really key to show that over time as well, to that 3 year mark.”

Objective markers, including C-reactive protein and fecal calprotectin, also continued to decline, reinforcing the depth of response. Additionally, no new safety signals emerged over three years of exposure.

“These are the kind of data that we're able to see when we continue to follow patients long-term in these development programs, and I think this is really exciting to see this continued signal, and to see those patients that even got better when they weren't all the way where we want them in terms of clinical remission, corticosteroid free remission at week 52. We see that sort of catch up, and that's exciting to me too,” Barnes said.

Editors’ note: Barnes reports relevant disclosures with AbbVie, Bristol-Meyers Squibb, Lilly, and Target RWE.

References

1. Laharie D, Clemow D, Sands BE, et al. Mirikizumab Demonstrated Sustained and Durable Long-Term Efficacy and Favorable Safety in Week 52 Endoscopic Responders with Crohn’s disease: 3-year VIVID-2 Open-Label Extension Interim Results. Presented at 21st Congress of European Crohn’s and Colitis Congress (ECCO), February 18–21, 2026, Stockholm, Sweden.

2. Brooks A. FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease. January 15, 2025. Accessed February 19, 2026. https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-crohn-disease