VIVID Post Hoc Analysis Supports Mirikizumab After Anti-TNF Failure in Crohn’s Disease

For patients with Crohn's disease who have already cycled through first-line biologic therapy, treatment decisions become increasingly complex while the likelihood of achieving meaningful, durable remission often declines. As more advanced therapies enter the market, clinicians are left navigating which agents can still deliver strong outcomes after anti-TNF failure.

New data presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, begin to address that question, offering insight into the performance of mirikizumab in a second-line setting. In an interview with HCPLive, Edward Barnes, MD, MPH, discussed findings from a post hoc analysis of the VIVID clinical trial program, focusing specifically on patients who had experienced failure of a single anti-TNF agent.

See also: Mirikizumab Maintains Disease Clearance in UC Through 4 Years in LUCENT-3 Extension

As Barnes emphasized, this population closely reflects the patients seen in routine clinical practice: those with moderate to severe disease who often have fewer effective options remaining. Historically, treatment response tends to diminish with each subsequent line of therapy, underscoring the importance of identifying therapies that maintain efficacy beyond first-line use.

VIVID Trial Data Highlight Clinical and Endoscopic Efficacy

The present analysis drew from patients enrolled in VIVID-1 and its open-label extension, VIVID-2, who had failed 1 prior anti-TNF therapy and had not been exposed to other advanced treatments. Outcomes assessed included clinical remission based on the Crohn’s Disease Activity Index (CDAI) and endoscopic response over time.

Results demonstrated clear separation between mirikizumab and placebo. By week 12, patients receiving mirikizumab had already shown improvements in clinical response and patient-reported outcomes.

Of note, these gains deepened over time, with statistically significant differences observed at week 52. At that point, 44.0% of patients treated with mirikizumab achieved CDAI remission compared with 15.5% in the placebo group (P <.001). Endoscopic response rates followed a similar pattern, with 37.1% of mirikizumab-treated patients achieving response versus 6.9% of those receiving placebo (P <.001).

Treat-to-Target Approach Reflected in “Treat-Through” Study Design

A key strength of the VIVID program, according to Barnes, is its “treat-through” design, which avoids treatment interruption and more closely mirrors real-world practice. This framework aligns with treat-to-target strategies in inflammatory bowel disease, where initial symptomatic improvement is followed by objective measures such as biomarker normalization and endoscopic healing.

“You see patients feel well first, and then over time, they achieve those deeper endpoints,” Barnes explained, noting that while some patients achieved early endoscopic response, the most robust outcomes emerged with continued therapy through one year.

“We saw patients feel well first, and then the longer we followed them on the therapy, they then met the other endpoints that we would expect,” Barnes said. “It's not to say that, you know, a quarter of patients weren't already hitting endoscopic response by that 12 week period, but the longer the patients were on therapy, they continued to feel well.”

Durable Remission Supports Long-Term Use of IL-23 Inhibition

Long-term data from VIVID-2 further reinforce the durability of response with mirikizumab. Among patients who achieved endoscopic response at week 52, the majority maintained benefit through 2 years. At week 104, 77.1% remained in clinical remission, while more than 80% sustained endoscopic response.

For clinicians, these findings provide an added layer of confidence, not only that mirikizumab can induce remission in a post–anti-TNF population, but that these responses are likely to persist with continued treatment.

Implications for Second-Line Treatment Sequencing in Crohn’s Disease

As the therapeutic landscape in Crohn’s disease continues to evolve, data like these help inform real-world decision-making. Mirikizumab’s demonstrated efficacy and durability in patients with prior anti-TNF exposure position it as a compelling second-line option, particularly in a setting where treatment attrition is common.

“These are important results for clinical practice, because often we're looking for data like this, how well does this match the patient that's going to walk in my door next and a clinical decision that I'm going to try to make?” Barnes said. “I think this is going to help people in their clinic with their clinical decision making.”

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

References

1. Gisbert JP, Ma C, Fantini MC, et al. MIRIKIZUMAB IS EFFICACIOUS IN MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE AFTER ONE PRIOR ANTI-TNF FAILURE. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

2. Lilly. Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 to demonstrate durable disease clearance in ulcerative colitis through four years. May 5, 2026. Accessed May 5, 2026. https://lilly.mediaroom.com/2026-05-05-Lillys-Omvoh-mirikizumab-mrkz-is-the-first-and-only-IL-23p19-to-demonstrate-durable-disease-clearance-in-ulcerative-colitis-through-four-years