Comparative Risk of Serious Infections with Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis

Virginia Solitano, Antonio Facciorusso, Tine Jess, Christopher Ma, Cesare Hassan, Alessandro Repici, Vipul Jairath, Alessandro Armuzzi, Siddharth Singh*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

24 Citations (Scopus)

Abstract

BACKGROUND & AIMS: Safety is a key consideration when choosing advanced therapies (biologic agents and oral small-molecule inhibitors/modulators) in patients with inflammatory bowel diseases (IBDs). We performed a systematic review and meta-analysis comparing the risk of serious infections with advanced therapies in active comparator studies.

METHODS: Through a systematic search until February 28, 2022, we included 20 head-to-head studies comparing risk of serious infections with tumor necrosis factor α (TNFα) antagonists, vedolizumab, ustekinumab, tofacitinib, filgotinib, and ozanimod in patients with IBD. We performed random-effects meta-analysis comparing different advanced therapies.

RESULTS: No significant difference was observed in the risk of serious infections between vedolizumab vs TNFα antagonists in all patients with IBD (17 cohorts: odds ratio [OR], 0.84; 95% CI, 0.68-1.04), with moderate heterogeneity (I 2 = 37%); on subgroup analysis, vedolizumab was associated with a lower risk of serious infections in patients with ulcerative colitis (11 cohorts: OR, 0.68; 95% CI, 0.56-0.83; I 2 = 0%), but not in Crohn's disease (CD) (9 cohorts: OR, 1.03; 95% CI, 0.78-1.35; I 2 = 42%). Age, sex, prior biologic exposure, and use of biologic monotherapy did not influence this association. In patients with CD, ustekinumab was associated with a lower risk of serious infections vs TNFα antagonists (3 cohorts: OR, 0.49; 95% CI, 0.25-0.93; I 2 = 16%) and vs vedolizumab (3 cohorts: OR, 0.40; 95% CI, 0.17-0.93; I 2 = 67%). Few studies compared other advanced therapies.

CONCLUSIONS: Vedolizumab may offer net benefit over TNFα antagonists in patients with ulcerative colitis, but not in CD. Ustekinumab may offer net benefit over TNFα antagonists and vedolizumab in patients with CD.

Original languageEnglish
JournalClinical Gastroenterology and Hepatology
Volume21
Issue number4
Pages (from-to)907-921.e2
ISSN1542-3565
DOIs
Publication statusPublished - Apr 2023

Bibliographical note

Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.

Keywords

  • Biologics
  • Comparative
  • Propensity Score
  • Risk-Benefit

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