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.

Parisio, L., Settanni, C. R., Varca, S., Laterza, L., Lopetuso, L. R., Napolitano, D., Schiavoni, E., Turchini, L., Fanali, C., Alfieri, N., Pizzoferrato, M., Papa, A., Pafundi, P. C., Armuzzi, A., Gasbarrini, A., Pugliese, D., Scaldaferri, F., Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission, <<JOURNAL OF GASTROINTESTINAL AND LIVER DISEASES>>, 2023; 32 (4): 452-459. [doi:10.15403/jgld-5084] [https://hdl.handle.net/10807/268439]

Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission

Settanni, Carlo Romano;Varca, Simone;Laterza, Lucrezia;Lopetuso, Loris Riccardo;Napolitano, Daniele;Schiavoni, Elisa;Turchini, Laura;Fanali, Caterina;Pizzoferrato, Marco;Papa, Alfredo;Pafundi, Pia Clara;Armuzzi, Alessandro;Gasbarrini, Antonio;Pugliese, Daniela;Scaldaferri, Franco
2023

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.
2023
Inglese
Parisio, L., Settanni, C. R., Varca, S., Laterza, L., Lopetuso, L. R., Napolitano, D., Schiavoni, E., Turchini, L., Fanali, C., Alfieri, N., Pizzoferrato, M., Papa, A., Pafundi, P. C., Armuzzi, A., Gasbarrini, A., Pugliese, D., Scaldaferri, F., Effectiveness and Safety of Switching from Intravenous to Subcutaneous Vedolizumab Formulation in Inflammatory Bowel Disease Patients in Clinical Remission, <<JOURNAL OF GASTROINTESTINAL AND LIVER DISEASES>>, 2023; 32 (4): 452-459. [doi:10.15403/jgld-5084] [https://hdl.handle.net/10807/268439]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/268439
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