Journal of Crohn's & Colitis · 11 authors, 15 centres
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This pooled analysis of two randomized controlled trials (LUCENT-1 induction and LUCENT-2 maintenance) found that mirikizumab significantly improved histological and endoscopic outcomes in patients with moderately-to-severely active ulcerative colitis compared to placebo. Early resolution of inflammation was associated with better long-term clinical outcomes.
This analysis pooled data from two randomized, placebo-controlled trials evaluating mirikizumab in ulcerative colitis. LUCENT-1 was a 12-week induction study (N=1162), and LUCENT-2 was a 40-week maintenance study (N=544) in patients who responded to induction. The primary focus was on histological and endoscopic endpoints. At Week 12, significantly more patients on mirikizumab achieved histological improvement, histological remission, endoscopic remission, and the composite endpoints histological-endoscopic mucosal improvement (HEMI) and histological-endoscopic mucosal remission (HEMR) versus placebo (p < 0.001). Similar significant improvements were seen at Week 40 in the maintenance phase. The treatment effect was generally consistent regardless of prior biologic failure. Predictors of response included lower baseline disease activity and no prior biologic failure. Notably, achieving histological and endoscopic remission at Week 12 was associated with better clinical outcomes at Week 40, such as corticosteroid-free remission and symptomatic remission.
