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.

Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study / Ribaldone, Davide Giuseppe; Parisio, Laura; Variola, Angela; Bossa, Fabrizio; Castiglione, Fabiana; Marzo, Manuela; Piazza, Nicole; Aratari, Annalisa; Savarino, Edoardo Vincenzo; Bodini, Giorgia; Mastronardi, Mauro; Micheli, Federica; Mazzuoli, Silvia; Ascolani, Marta; Viganò, Chiara; Cappello, Maria; Bezzio, Cristina; Ciccocioppo, Rachele; Scardino, Giulia; Sarli, Ennio; Pugliese, Daniela; Scaldaferri, Franco; Napolitano, Daniele; Todeschini, Alessia; Geccherle, Andrea; Colaci, Nicoletta; Guerra, Maria; Annese, Monica; Testa, Anna; Caiazzo, Anna; Conforti, Francesco Simone; Festa, Stefano; Lorenzon, Greta; Marra, Antonella; Magiotta, Ambra; Baccini, Flavia; Amato, Arnaldo; Poshnjari, Anxhela; Vernero, Marta; Caprioli, Flavio; Caviglia, Gian Paolo. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1878-3562. - 56:1(2024), pp. 77-82. [10.1016/j.dld.2023.07.011]

Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study

Castiglione, Fabiana;Testa, Anna;Caiazzo, Anna;Marra, Antonella;
2024

Abstract

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.
2024
Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study / Ribaldone, Davide Giuseppe; Parisio, Laura; Variola, Angela; Bossa, Fabrizio; Castiglione, Fabiana; Marzo, Manuela; Piazza, Nicole; Aratari, Annalisa; Savarino, Edoardo Vincenzo; Bodini, Giorgia; Mastronardi, Mauro; Micheli, Federica; Mazzuoli, Silvia; Ascolani, Marta; Viganò, Chiara; Cappello, Maria; Bezzio, Cristina; Ciccocioppo, Rachele; Scardino, Giulia; Sarli, Ennio; Pugliese, Daniela; Scaldaferri, Franco; Napolitano, Daniele; Todeschini, Alessia; Geccherle, Andrea; Colaci, Nicoletta; Guerra, Maria; Annese, Monica; Testa, Anna; Caiazzo, Anna; Conforti, Francesco Simone; Festa, Stefano; Lorenzon, Greta; Marra, Antonella; Magiotta, Ambra; Baccini, Flavia; Amato, Arnaldo; Poshnjari, Anxhela; Vernero, Marta; Caprioli, Flavio; Caviglia, Gian Paolo. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1878-3562. - 56:1(2024), pp. 77-82. [10.1016/j.dld.2023.07.011]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/949441
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