Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis

Theodore Rokkas, Javier P. Gisbert, Konstantinos Ekmektzoglou, Themistocles Dassopoulos, Yaron Niv, Colm O'Morain

Research output: Contribution to journalArticlepeer-review

Abstract

Background and aims Βiologic agents and small molecules have expanded the therapeutic armamentarium of moderate to severe ulcerative colitis (UC). However, their comparative efficacy and safety performance as maintenance treatments have not been sufficiently explored. We performed a systematic review and network meta-analysis (NWM) to assess the comparative efficacy and safety of all approved and emerging treatments for maintenance in moderate to severe UC. Methods We searched Pubmed/Medline, EMBASE, and Cochrane Library databases for relevant RCTs through April 2023. The primary endpoint was clinical remission at the end of the maintenance therapy. Data were analyzed by means of a Bayesian NWM. The ranking probability concerning efficacy and safety was evaluated by means of surfaces under cumulative ranking (SUCRA) values. Results There were 20 eligible RCTs with 7660 patients randomized to 20 treatments. RCTs were grouped into two study designs, that is, re-randomization of patients after an induction period and treat-through patients. Concerning efficacy, in re-randomized patients, upadacitinib 30 mg/day was ranked first (SUCRA 94.9%) whereas in treat-through patients etrasimod 2 mg/day was ranked first (SUCRA 91.1%). The integrated efficacy-safety hierarchical analysis, showed that tofacitinib 10 mg had the best efficacy-safety therapeutic profile in re-randomized patients, whereas in treat-through patients infliximab 3.5 mg/Kg Q8W showed the best efficacy-safety profile. Conclusion For maintenance treatment, in moderate to severe UC, this NWM showed that upadacitinib 30 mg/day and etrasimod 2 mg/day were ranked best for efficacy in re-randomized and treat-through patients respectively. Tofacitinib 10 mg/day and infliximab 3.5 mg/Kg Q8W showed the best efficacy-safety therapeutic profile in re-randomized and treat-through patients respectively.

Original languageEnglish
Pages (from-to)520-533
Number of pages14
JournalEuropean Journal of Gastroenterology and Hepatology
Volume36
Issue number5
DOIs
StatePublished - 1 May 2024

Keywords

  • biologic therapies
  • efficacy
  • JAK inhibitors
  • maintenance treatment
  • network meta-analysis
  • safety
  • small molecules
  • ulcerative colitis

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