J Crohns Colitis. 2023 Jul 26:jjad113. doi: 10.1093/ecco-jcc/jjad113. Online ahead of print.
ABSTRACT
BACKGROUND AND AIMS: The benefit of continuing 5-aminosalicylic acid [5-ASA] treatment when escalating to advanced therapies in patients with inflammatory bowel disease [IBD] is unclear. Vedolizumab is a gut-selective monoclonal anti-α4β7-integrin antibody used to treat moderate to severe IBD. Clinical trial data were analysed post hoc to assess the impact of 5-ASA co-treatment on vedolizumab efficacy and safety in patients with IBD.
METHODS: Data were analysed from patients aged 18-80 years with moderate to severe ulcerative colitis [UC]/Crohn’s disease [CD] receiving intravenous [IV]/subcutaneous [SC] vedolizumab. Efficacy data were from four studies [GEMINI 1 and 2 and VISIBLE 1 and 2]; safety data were from seven studies [GEMINI 1‒3 and long-term, VISIBLE 1, 2 and open-label extension]. Impact of 5-ASA co-treatment on clinical and endoscopic outcomes at Weeks 6 and 52 was assessed using multivariate analysis (adjusted odds ratios [aORs] with 95% confidence intervals [CIs]).
RESULTS: There were no significant differences in UC clinical remission [Mayo score ≤2, no subscore >1] rates with versus without 5-ASA at Week 6 (20.7% vs 20.4%, respectively; aOR 0.77, 95% CI 0.43-1.38) or at Week 52 (45.1% vs 40.6%; aOR 1.14, 0.70-1.86), and in CD clinical remission [CD activity index score ≤150] rates at Week 6 (41.4% vs 35.1%; 1.26, 0.86-1.85) or at Week 52 (49.6% vs 37.8%; 1.35, 0.91-1.99). Incidence of enteric and all infections in vedolizumab IV/SC-treated patients was low with and without 5-ASA.
CONCLUSION: Continuation of concomitant oral 5-ASA after starting vedolizumab had no significant impact on clinical and endoscopic outcomes.
PMID:37492976 | DOI:10.1093/ecco-jcc/jjad113
