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

Takeaway

• This meta-analysis found that ustekinumab was safe and effective in the real-world treatment of moderate-to-severe inflammatory bowel disease (IBD).

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.

Limitations

• Heterogeneity among studies.
• Risk of bias and confounding.

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