Scholarlink

Background and aims <p>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.</p> Methods <p>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).</p> Results <p>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]; <i>p</i>  &lt;  0.00001; NNT = 4), clinical remission by 74% (37.1% vs. 20.0%; RR 1.74; 95% CI [1.50, 2.02]; <i>p </i> &lt;  0.00001; NNT = 7), and endoscopic remission by 92% (28.7% vs. 15.4%; RR 1.92; 95% CI [1.63, 2.27]; <i>p </i> &lt;  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]; <i>p</i>  &lt;  0.00001; NNH = 24), treatment discontinuation (2.5% vs. 7.5%; RR 0.33; 95% CI [0.20, 0.56]; <i>p  &lt;  </i>0.0001; NNH = 20), and IBD worsening (3.3% vs. 13%; RR 0.26; 95% CI [0.19, 0.36]; <i>p </i> &lt;  0.00001; NNT = 11).</p> Conclusion <p>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.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 发表日期：

    2025年9月29日

查看全文
  • Joel Gabin Konlack Mekontso,
  • Joseph Yvan Bena Nnang,
  • Samuel G. J. Fodop,
  • Bishoy I. B. Elkoumes,
  • Guy Loic Nguefang Tchoukeu,
  • Anifatou B. Kortim,
  • Ticha B. T. Tembi,
  • Akil Olliverre,
  • Jarin Prasa,
  • John Trillo

摘要

Background and aims

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.

Methods

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).

Results

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).

Conclusion

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.