Scholarlink

Background <p>Crohn’s disease (CD) management remains challenging, particularly in patients refractory to multiple biologics. Risankizumab (RZB), a selective IL-23 p19 inhibitor, has recently been approved for CD. We performed a systematic review and meta-analysis to assess the efficacy and safety of RZB in moderate-to-severe CD using both randomized controlled trials (RCTs) and real-world evidence (RWE).</p> Methods <p>We searched PubMed, Scopus, Web of Science, and Embase from inception to April 2025. We included RCTs comparing RZB with placebo and observational studies evaluating RZB in CD. Primary endpoints were clinical remission at induction and maintenance. Secondary endpoints included endoscopic remission and safety outcomes. This study was registered with PROSPERO (CRD420251030978).</p> Results <p>Five RCTs and nine observational studies (<i>n</i> = 3275) were included. In RCTs, RZB significantly increased clinical remission rates at induction (RR: 1.90, 95% CI [1.63; 2.20]) and maintenance (RR: 1.34, 95% CI [1.15; 1.55]) compared with placebo. Endoscopic remission was also significantly higher with RZB compared to placebo at induction (RR: 3.25, 95% CI [2.43; 4.35]) and maintenance (RR: 2.04, 95% CI [1.22; 3.42]). Pooled RWE demonstrated clinical remission rates of 57% at 12 weeks and 44% at 1 year. Subgroup analyses confirmed efficacy in patients with prior ustekinumab failure. No increased risk of serious adverse events was observed.</p> Conclusions <p>Risankizumab demonstrates robust efficacy in inducing and maintaining clinical and endoscopic remission in moderate-to-severe CD. Real-world data confirm its sustained effectiveness and favorable safety profile in refractory populations (defined as patients with prior failure of one or more biologics or advanced therapies), supporting its positioning in the therapeutic landscape.</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 Risankizumab in Crohn’s Disease: A Systematic Review and Meta-Analysis of Randomized Trials and Real-World Evidence

  • 期刊论文

  • 发表日期：

    2026年5月18日

查看全文
  • Alaa Abdrabou Abouelmagd,
  • Mazen Negmeldin Yassin,
  • Dina Essam Abo-elnour,
  • Menna M. Aboelkhier,
  • Nada G. Hamam,
  • Abdelrahman A. Elareef,
  • Mohamed Saad Sayed,
  • Mazen Ibrahem Gado,
  • Talaat M. elqadi,
  • Ahmed Elazab,
  • Yasser M. Mousa,
  • Mohamed Diaa Gabra,
  • Bram Verstockt

摘要

Background

Crohn’s disease (CD) management remains challenging, particularly in patients refractory to multiple biologics. Risankizumab (RZB), a selective IL-23 p19 inhibitor, has recently been approved for CD. We performed a systematic review and meta-analysis to assess the efficacy and safety of RZB in moderate-to-severe CD using both randomized controlled trials (RCTs) and real-world evidence (RWE).

Methods

We searched PubMed, Scopus, Web of Science, and Embase from inception to April 2025. We included RCTs comparing RZB with placebo and observational studies evaluating RZB in CD. Primary endpoints were clinical remission at induction and maintenance. Secondary endpoints included endoscopic remission and safety outcomes. This study was registered with PROSPERO (CRD420251030978).

Results

Five RCTs and nine observational studies (n = 3275) were included. In RCTs, RZB significantly increased clinical remission rates at induction (RR: 1.90, 95% CI [1.63; 2.20]) and maintenance (RR: 1.34, 95% CI [1.15; 1.55]) compared with placebo. Endoscopic remission was also significantly higher with RZB compared to placebo at induction (RR: 3.25, 95% CI [2.43; 4.35]) and maintenance (RR: 2.04, 95% CI [1.22; 3.42]). Pooled RWE demonstrated clinical remission rates of 57% at 12 weeks and 44% at 1 year. Subgroup analyses confirmed efficacy in patients with prior ustekinumab failure. No increased risk of serious adverse events was observed.

Conclusions

Risankizumab demonstrates robust efficacy in inducing and maintaining clinical and endoscopic remission in moderate-to-severe CD. Real-world data confirm its sustained effectiveness and favorable safety profile in refractory populations (defined as patients with prior failure of one or more biologics or advanced therapies), supporting its positioning in the therapeutic landscape.