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- Title
Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission.
- Authors
Parisio, Laura; Settanni, Carlo Romano; Varca, Simone; Laterza, Lucrezia; Lopetuso, Loris Riccardo; Napolitano, Daniele; Schiavoni, Elisa; Turchini, Laura; Fanali, Caterina; Alfieri, Norma; Pizzoferrato, Marco; Papa, Alfredo; Pafundi, Pia Clara; Armuzzi, Alessandro; Gasbarrini, Antonio; Pugliese, Daniela; Scaldaferri, Franco
- Abstract
Background & Aims: Subcutaneous vedolizumab formulation has been shown to be as effective and safe as the intravenous one in randomized control trials. Real-life data are limited especially for patients receiving long-term intravenous therapy. This study aimed to evaluate the safety and effectiveness of switching from intravenous to subcutaneous vedolizumab in a large cohort of patients with stable clinical remission. Methods: In this prospective cohort study, we enrolled consecutive patients attending our center between September 2021 and April 2022. The baseline demographic characteristics, 12- and 24-weeks follow-up clinical activity, C-reactive protein levels, and adverse events were recorded. The primary endpoint was to assess combined steroid-free clinical remission plus biochemical remission 24-week after the switch. Results: 93 patients (43 Crohn's disease, 50 ulcerative colitis), switched to subcutaneous vedolizumab after a median duration of intravenous treatment of 36 months [IQR 16-52]. At baseline, 80 patients (86%) had a combined remission. At 24-week, 89.2% (n=74) maintained combined steroid-free clinical remission plus biochemical remission. 25 adverse events were reported, mostly SARS-CoV-2 infections and injection site reactions, with a further four recurrence episodes. Twelve patients (12.9%) discontinued subcutaneous administration and restarted intravenous vedolizumab. Conclusions: Switching from intravenous to subcutaneous vedolizumab can be considered effective and safe for maintaining remission in patients with inflammatory bowel disease. In addition, this might reduce healthcare costs. However, large-scale real-life studies with long-term follow-up are necessary.
- Subjects
INFLAMMATORY bowel diseases; DISEASE remission; CROHN'S disease; VEDOLIZUMAB; ULCERATIVE colitis
- Publication
Journal of Gastrointestinal & Liver Diseases, 2023, Vol 32, Issue 4, p452
- ISSN
1841-8724
- Publication type
Article
- DOI
10.15403/jgld-5084