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ECB-ART-52449
Dig Liver Dis 2024 Jan 01;561:77-82. doi: 10.1016/j.dld.2023.07.011.
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Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study.

Ribaldone DG , Parisio L , Variola A , Bossa F , Castiglione F , Marzo M , Piazza N , Aratari A , Savarino EV , Bodini G , Mastronardi M , Micheli F , Mazzuoli S , Ascolani M , Viganò C , Cappello M , Bezzio C , Ciccocioppo R , Scardino G , Sarli E , Pugliese D , Scaldaferri F , Napolitano D , Todeschini A , Geccherle A , Colaci N , Guerra M , Annese M , Testa A , Caiazzo A , Conforti FS , Festa S , Lorenzon G , Marra A , Magiotta A , Baccini F , Amato A , Poshnjari A , Vernero M , Caprioli F , Caviglia GP , Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) .


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BACKGROUND: The administration of biological drugs in inflammatory bowel diseases (IBD) is increasingly moving from intravenous to subcutaneous formulations. AIMS: To evaluate the efficacy and safety of vedolizumab subcutaneous administration after switching from intravenous administration in ulcerative colitis (UC) patients in corticosteroid-free clinical remission. METHODS: An observational, multicentre, prospective study was conducted by the Italian Group for the study of IBD (IG-IBD). UC patients in clinical remission (pMAYO < 2) not receiving steroids for > 8 months before the switch, and with at least 6 months of follow-up were included. Switch from intravenous to subcutaneous vedolizumab was defined as successful in patients not experiencing a disease flare (pMAYO ≥ 2) or needing oral steroids or stopping subcutaneous vedolizumab during the 6 months of follow-up after the switch. RESULTS: Overall, 168 patients were included. The switch was a success in 134 patients (79.8%). Vedolizumab retention rate was 88.7% at month six. C-reactive protein and faecal calprotectin values did not change after the switch (p = 0.07 and p = 0.28, respectively). Ten of the 19 patients who stopped subcutaneous formulation switched back to intravenous formulation recapturing clinical remission in 80%. Side effects were observed in 22 patients (13.1%). CONCLUSION: Effectiveness of switching from intravenous to subcutaneous vedolizumab formulation in UC patients in steroid-free clinical remission is confirmed in a real-world setting.

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