Efficacy and safety of Mirikizumab in the treatment of moderate to severe inflammatory bowel diseases: a systematic review and updated meta-analysis

Inflammatory bowel diseases (IBD) remain challenging to treat despite advances in biologic therapies. Mirikizumab, a selective anti-IL-23p19 monoclonal antibody, shows promise, but its efficacy and safety across IBD populations require a comprehensive evaluation.

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing Mirikizumab to placebo in moderate-to-severe IBD. We assessed clinical response, clinical remission, endoscopic remission, adverse events (AEs) and treatment discontinuation. We applied a random-effects model and calculated numbers needed to treat (NNT) and harm (NNH).

We included four RCTs (2380 patients). Mirikizumab significantly increased the likelihood of clinical response by 69% (61.0% vs. 36.6%; RR 1.69; 95% CI [1.35, 2.10]; p  <  0.00001; NNT = 4), clinical remission by 74% (37.1% vs. 20.0%; RR 1.74; 95% CI [1.50, 2.02]; p  <  0.00001; NNT = 7), and endoscopic remission by 92% (28.7% vs. 15.4%; RR 1.92; 95% CI [1.63, 2.27]; p  <  0.00001; NNT = 8). This efficacy extended to biologic-failed patients and across both IBD populations. Mirikizumab was safe, with reduced rates of serious AEs (5.2% vs. 9.1%; RR 0.53; 95% CI [0.41, 0.70]; p  <  0.00001; NNH = 24), treatment discontinuation (2.5% vs. 7.5%; RR 0.33; 95% CI [0.20, 0.56]; p  <  0.0001; NNH = 20), and IBD worsening (3.3% vs. 13%; RR 0.26; 95% CI [0.19, 0.36]; p  <  0.00001; NNT = 11).

Mirikizumab significantly improves clinical and endoscopic outcomes in moderate-to-severe IBD, with consistent efficacy in biologic-refractory disease and a favorable safety profile, making it a valuable therapeutic option.