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;404:2423–36 doi: 10.1016/S0140-6736(24)01762-8
Ferrante et al. conducted a phase 3 trial evaluating the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease. The study demonstrated that mirikizumab significantly improved clinical and endoscopic outcomes compared with placebo at week 52, with a favourable safety profile and tolerable adverse events.
This multicentre, randomised study involved 1150 patients across 33 countries, allocated to receive mirikizumab, ustekinumab, or placebo. The trial assessed key clinical endpoints, including patient-reported and endoscopic responses. The results underscore mirikizumab as an effective treatment option for patients regardless of prior failure to standard therapy. However, mirikizumab was
non-inferior to ustekinumab in achieving clinical remission by CDAI-treat-through at Wk52.
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