Eur J Clin Invest. 2024 Jul 9:e14283. doi: 10.1111/eci.14283. Online ahead of print.

Ferdinando D'Amico ¹, Luca Massimino ², Giulia Palmieri ¹, Arianna Dal Buono ³, Roberto Gabbiadini ³, Benedicte Caron ^4 5 6 7, Paula Moreira ⁸, Isabel Silva ⁸, Maia Bosca-Watts ⁹, Tommaso Innocenti ¹⁰, Gabriele Dragoni ¹⁰, Cristina Bezzio ^3 11, Alessandra Zilli ¹, Federica Furfaro ¹, Simone Saibeni ¹², María Chaparro ¹³, María José García ¹⁴, George Michalopoulos ¹⁵, Nikos Viazis ¹⁶, Gerassimos J Mantzaris ¹⁶, Pierre Ellul ¹⁷, Javier P Gisbert ¹³, Fernando Magro ⁸, Laurent Peyrin-Biroulet ^{4 5 6 7 18}, Alessandro Armuzzi ^3 11, Federica Ungaro ², Silvio Danese ¹, Gionata Fiorino ¹⁹, Mariangela Allocca ¹

Author information

¹Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.

²Experimental Gastroenterology Unit, Division of Immunology, Transplantation and Infectious Disease, IRCCS Ospedale San Raffaele, Milan, Italy.

³IBD Center, IRCCS Humanitas Research Hospital, Milan, Italy.

⁴Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

⁵INSERM, NGERE, University of Lorraine, Nancy, France.

⁶INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

⁷FHU-CURE, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

⁸CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.

⁹IBD Unit, Digestive Medicine Department, Hospital Clínico Universitario de Valencia, Valencia, Spain.

¹⁰IBD Referral Centre, Clinical Gastroenterology Unit, Careggi University Hospital, Florence, Italy.

¹¹Department of Biomedical Sciences, Humanitas University, Milan, Italy.

¹²IBD Center, Gastroenterology Unit, Rho Hospital, ASST Rhodense, Milan, Italy.

¹³Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad Autónoma de Madrid (UAM), Madrid, Spain.

¹⁴Gastroenterology and Hepatology Department, Hospital Universitario Marqués de Valdecilla, Grupo de Investigación Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas. Instituto de Investigación Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.

¹⁵Department of Gastroenterology, General Hospital of Athens "G. Gennimatas", Athens, Greece.

¹⁶Department of Gastroenterology, 'Evangelismos-Polykliniki' GHA, Athens, Greece.

¹⁷Division of Gastroenterology, Mater Dei Hospital, Msida, Malta.

¹⁸Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, Neuilly sur Seine, France.

¹⁹Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, Rome, Italy.

Abstract

Background and aims: Subcutaneous (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.

Methods: This 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.

Results: Two 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.

Conclusion: SC IFX and VDZ are effective in daily clinical practice in IBD patients. Switching patients in remission reduces the risk of negative outcomes