Mirikizumab is safe and effective in patients with moderate-to-severe Crohn’s disease

1. The composite of patient-reported clinical response and endoscopic response was significantly greater in mirikizumab versus placebo.

2. Clinical remission showed a similar trend between mirikizumab and placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Existing treatments for Crohn’s disease fail to achieve long-term remission in many patients. Mirikizumab, a monoclonal antibody targeting IL-23p19, has shown efficacy in ulcerative colitis and may hold promise for Crohn’s disease. This randomized controlled trial aimed to evaluate the efficacy and safety of mirikizumab in adults with moderate-to-severe Crohn’s disease refractory to existing therapies. The primary outcome of this study was a composite of patient-reported clinical response and endoscopic response, while a key secondary outcome was clinical remission at week 52. According to study results, mirikizumab significantly improved clinical and endoscopic responses compared to placebo. Although this study was well done, it was limited by its reliance on non-responder imputation methods, which may overestimate treatment effects in real-world settings.

Click to read the study in The Lancet

Relevant Reading: Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis

In-depth [randomized controlled trial]: Between July 23, 2019, and Aug 23, 2023, 2665 patients were screened for eligibility across 324 sites in 33 countries. Included were patients with moderate-to-severe Crohn’s disease who had an inadequate response, loss of response, or intolerance to conventional therapies. Altogether, 1065 patients (579 to mirikizumab, 287 to ustekinumab, 199 to placebo) were included in the final analysis. The primary outcome of a composite patient-reported clinical response at week 12 and endoscopic response at week 52 was significantly greater in the mirikizumab group compared to placebo (38.0% vs. 9.0%, 99.5% confidence interval [CI] 20.6-36.8, p<0.0001). The secondary outcome of clinical remission based on the Crohn’s Disease Activity Index at week 52 showed a similar trend (45.4% in mirikizumab vs. 19.6% in placebo, 99.5% CI 15.9-35.6, p<0.0001). Overall, findings from this study suggest that mirikizumab is a safe and effective treatment for moderate-to-severe Crohn’s disease.

Image: PD

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