Real-world Efficacy and Safety of Ustekinumab in Inflammatory Bowel Disease

Sarfaroj Khan 


March 22, 2021


Why this matters

  • This is the most comprehensive systematic review and meta-analysis assessing effectiveness and safety of ustekinumab in Crohn's disease (CD) and the first to include ulcerative colitis (UC) studies.

Study design

  • Meta-analysis of 41 studies (38 CD; 3 UC) including 4400 ustekinumab-treated patients with IBD.

  • Primary outcome: clinical remission after induction (8-16 weeks) and during maintenance therapy (48-56 weeks).

  • Funding: None disclosed.

Key results

  • Pooled clinical remission rates for CD and UC were 34% (95% CI, 26-42%; I2, 94%) and 39% (95% CI, 23-56%; I2, 62%), respectively, following induction and 31% (95% CI, 25-38%; I2, 92.9%) and 53% (1 study), respectively, at 1 year.

  • Pooled clinical response rate for CD was 60% (95% CI, 53-67%; I2, 92.5%) following induction and 42% (95% CI, 33-50%; I2, 93.8%) at 1 year; post-induction response rate for UC was 50% (2 studies).

  • At 1 year, corticosteroid-free remission rate for CD was 23% (95% CI, 17-29%; I2, 87.80%).

  • For CD, pooled rates of endoscopic response and endoscopic remission were 61% (95% CI, 50-72%; I2, 81.9%) and 25% (95% CI, 13-38%; I2, 89.8%), respectively, both at a median timepoint of 52 weeks following induction.

  • Serious AEs were reported in 86 (5.6%) patients with an pooled incidence rate of 0.5 (95% CI, 0.1-2.3).

  • Pregnancy outcomes were similar to the general population.

  • One-third of patients with active baseline perianal disease responded or were in remission with fistula healing following treatment with ustekinumab.


  • Heterogeneity among studies.

  • Risk of bias and confounding.


Honap S, Meade S, Ibraheim H, Irving PM, Jones MP, Samaan MA. Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2021 Mar 16 [Epub ahead of print]. doi: 10.1007/s10620-021-06932-4. PMID: 33723700.  View abstract 

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.


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