Crohn's treatment with ustekinumab shows benefit in observational studies

  • Macaluso FS & al.
  • Expert Opin Biol Ther
  • 20 Dec 2019

  • International Clinical Digest
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Takeaway

  • Ustekinumab is effective for treating patients with Crohn's disease (CD) and has a reassuring safety profile, say the authors of this meta-analysis of real-life observational studies.

Why this matters

  • This analysis affirms results from randomized controlled trials of ustekinumab, which received European Commission approval in 2016 for treating adults with moderate to severe active CD.

Study design

  • Researchers identified 13 observational studies assessing the clinical effectiveness of ustekinumab for treating patients with active CD (N=1450; median age range, 34.0-44.6 years) by searching the Embase and Medline biomedical literature databases.
  • Funding: None.

Key results

  • Patients received ustekinumab subcutaneously in 7 studies and intravenously in 6 studies.
  • The pooled estimated clinical response rate was 56% (95% CI, 43%-68%; range, 16%-94%; I2=94%); the pooled estimated remission rate was 34% (95% CI, 25%-45%; range, 15%-58%; I2=90%).
  • Clinical response was higher among studies with subcutaneous induction (68%) vs intravenous induction (38%; P=.01).

Limitations

  • The number of included studies was low.
  • Meta-analysis results reflect differences among group averages, rather than individual patients.