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Background and objective <p>Targeting the interleukin-23 (IL-23) pathway is an emerging therapeutic strategy for moderate to severe ulcerative colitis (UC). This systematic review and meta-analysis evaluated the efficacy and safety of IL-23 inhibitors for induction and maintenance therapy in UC.</p> Methods <p>A systematic search of PubMed, Cochrane, and Google Scholar was conducted up to May 2025 to identify randomized controlled trials (RCTs) of IL-23 inhibitors (mirikizumab, risankizumab, guselkumab) in UC. Data were analyzed using Review Manager (RevMan 5.4) with a random-effects model.</p> Results <p>Seven RCTs (four induction, three maintenance) including 4203 patients were analyzed. IL-23 inhibitors significantly increased clinical remission during both induction (RR 1.52) and maintenance (RR 1.62). Rates of histo-endoscopic healing were also higher with IL-23 blockade in both induction (RR 2.53) and maintenance (RR 1.81). Importantly, IL-23 inhibitors were associated with a reduced risk of serious adverse events during induction (RR 0.39), with no significant difference observed during maintenance (RR 0.68). Other outcomes, including clinical response and corticosteroid-free remission, also consistently favored IL-23 blockade.</p> Conclusion <p>IL-23 inhibitors provide significant improvements in clinical remission and mucosal healing, with a favorable safety profile, particularly during induction therapy in moderate to severe UC.</p>

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Safety and efficacy of IL-23 inhibitors in patients with moderate to severe ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月30日

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  • Hamza Muhammad Amin,
  • Sundas Hasan,
  • Reem Abukhater,
  • Rachel Lilley,
  • Arif Atique,
  • Maheen Sattar Shoaib,
  • Qutaiba Albustanji,
  • Humza Sadique,
  • Saad Muhammad Khalid,
  • Ali Hasan,
  • Salman Majeed,
  • Muhammad Aamir Shahzad,
  • Maryam Shahzad,
  • Mushood Ahmed,
  • Raheel Ahmed,
  • Syed Anjum Gardezi

摘要

Background and objective

Targeting the interleukin-23 (IL-23) pathway is an emerging therapeutic strategy for moderate to severe ulcerative colitis (UC). This systematic review and meta-analysis evaluated the efficacy and safety of IL-23 inhibitors for induction and maintenance therapy in UC.

Methods

A systematic search of PubMed, Cochrane, and Google Scholar was conducted up to May 2025 to identify randomized controlled trials (RCTs) of IL-23 inhibitors (mirikizumab, risankizumab, guselkumab) in UC. Data were analyzed using Review Manager (RevMan 5.4) with a random-effects model.

Results

Seven RCTs (four induction, three maintenance) including 4203 patients were analyzed. IL-23 inhibitors significantly increased clinical remission during both induction (RR 1.52) and maintenance (RR 1.62). Rates of histo-endoscopic healing were also higher with IL-23 blockade in both induction (RR 2.53) and maintenance (RR 1.81). Importantly, IL-23 inhibitors were associated with a reduced risk of serious adverse events during induction (RR 0.39), with no significant difference observed during maintenance (RR 0.68). Other outcomes, including clinical response and corticosteroid-free remission, also consistently favored IL-23 blockade.

Conclusion

IL-23 inhibitors provide significant improvements in clinical remission and mucosal healing, with a favorable safety profile, particularly during induction therapy in moderate to severe UC.