• Eur. J. Clin. Invest. · Nov 2024

    Multicenter Study

    An international multicentre study of SwiTching from Intravenous to subcutaneous inflixiMab and vEdolizumab in inflammatory bowel diseases: The TIME study.

    • Ferdinando D'Amico, Luca Massimino, Giulia Palmieri, Arianna Dal Buono, Roberto Gabbiadini, Benedicte Caron, Paula Moreira, Isabel Silva, Maia Bosca-Watts, Tommaso Innocenti, Gabriele Dragoni, Cristina Bezzio, Alessandra Zilli, Federica Furfaro, Simone Saibeni, María Chaparro, María José García, George Michalopoulos, Nikos Viazis, Gerassimos J Mantzaris, Pierre Ellul, Javier P Gisbert, Fernando Magro, Laurent Peyrin-Biroulet, Alessandro Armuzzi, Federica Ungaro, Silvio Danese, Gionata Fiorino, and Mariangela Allocca.
    • Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.
    • Eur. J. Clin. Invest. 2024 Nov 1; 54 (11): e14283e14283.

    Background And AimsSubcutaneous (SC) formulations of infliximab (IFX) and vedolizumab (VDZ) are approved for the treatment of inflammatory bowel diseases (IBDs). Our aim was to evaluate the effectiveness of switching from intravenous (IV) to SC formulations of IFX and VDZ in IBDs.MethodsThis multicentre, retrospective study collected data of adult patients with Crohn's disease (CD) or ulcerative colitis (UC) switched to SC IFX or VDZ. The primary endpoint was clinical remission at 12 months stratified based on timing of switch. A composite endpoint consisting of therapy discontinuation, reverse-switch, need for steroids, and drug optimization was evaluated. A multivariate analysis investigated the association between patients' characteristics and outcomes.ResultsTwo hundred and thirty-one patients (59% UC, 53% male, mean age 44 ± 15 years, 68% IFX) from 13 centres were included. The switch occurred at Week 6 in a third of cases (36%). Median time to switch was 13 months. Most patients switched to SC IFX and VDZ were in clinical remission at 3 (87% and 77%), 6 (86% and 83%) and 12 (63% and 60%) months. In the multivariate analysis, there was no difference in clinical remission rate at 12 months; however, patients switched at Week 6 had a higher rate of experiencing any therapeutic changes at 3 (false discovery rate (FDR) = .002), 6 (FDR <1 × 10-10) or 12 months (FDR = .08). Clinical disease activity at baseline (only in UC) (FDR = .07) and previous exposure to biologics (FDR = .001) were risk factors for composite endpoint at 6 and 12 months.ConclusionSC IFX and VDZ are effective in daily clinical practice in IBD patients. Switching patients in remission reduces the risk of negative outcomes.© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.

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