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

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.

Informations de copyright

Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of Interest and source of funding Davide Giuseppe Ribaldone Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen. Laura Parisio Nothing to declare. Angela Variola Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Pfizer, Ferring, MSD, Zambon, Abbvie, Celltrion. Fabrizio Bossa Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen, Abbvie, MSD, Celltrion, Mundipharma. Fabiana Castiglione Consultant for Abbvie, Fresenius, Sandoz, Galapagos, Pfizer, Takeda, Janssen, Biogen, Celltrion. Manuela Marzo Nothing to declare. Nicole Piazza Nothing to declare. Annalisa Aratari Advisory Board for Galapagos. Consultant for Abbvie, Galapagos, Pfizer, Takeda, Janssen. Edoardo Vincenzo Savarino Speaker for Abbvie, Agave, AGPharma, Alfasigma, Aurora Pharma, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Fresenius Kabi, Galapagos, Janssen, JB Pharmaceuticals, Innovamedica/Adacyte, Malesci, Mayoly Biohealth, Omega Pharma, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Tillots, Unifarco. Consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr. Falk, Fenix Pharma, Fresenius Kabi, Janssen, JB Pharmaceuticals, Merck & Co, Nestlè, Reckitt Benckiser, Regeneron, Sanofi, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco. He received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco, Zeta Farmaceutici. Giorgia Bodini Nothing to declare. Mauro Mastronardi Lecture fees and Advisory Board per Takeda, Galapagos, Biogen, AuroraPharma Abbvie. Silvia Mazzuoli Lecture fees and Advisory Board per Janssen, Galapagos, Takeda, Abbvie, MSD, Pfizer. Federica Micheli Nothing to declare. Silvia Mazzuoli Nothing to declare. Marta Ascolani Nothing to declare. Chiara Viganò Lecture fees and Advisory Board for Janssen-Cilag, Takeda, Galapagos, Pfizer, Celltrion, Alfasigma. Maria Cappello Lecture fees and Advisory Board for Takeda, Janssen-Cilag, Biogen, Galapagos, Pfizer. Cristina Bezzio Lecture fees and Consultant for Ferring, Takeda, Janssen, Abbvie, Galapagos, Pfizer. Nothing to declare. Rachele Ciccocioppo Advisory Board for Galapagos, Takeda; scientific consultant for Revalma, and lecture fee from Fresenius-Kabi and Takeda. Giulia Scardino Nothing to declare. Ennio Sarli Nothing to declare. Daniela Pugliese Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen, MSD, Pfizer. Franco Scaldaferri Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Ferring, Sandoz, MSD, Pfizer, Celltrion. Daniele Napolitano Nothing to declare. Alessia Todeschini. Andrea Geccherle Nothing to declare. Nicoletta Colaci Nothing to declare. Maria Guerra. Nothing to declare. Monica Annese Nothing to declare. Anna Testa Lecture fees and Consultant for Takeda, Janssen, Abbvie, Galapagos, Pfizer. Anna Caiazzo Nothing to declare. Francesco Simone Conforti Nothing to declare. Stefano Festa Advisory Board for Janssen-Cilag. Consultancy fees for Takeda, Pfizer. Greta Lorenzon Nothing to declare. Antonella Marra Nothing to declare. Ambra Magiotta Nothing to declare. Flavia Baccini Nothing to declare. Arnaldo Amato Nothing to declare. Anxhela Poshnjari Nothing to declare. Marta Vernero Nothing to declare. Flavio Caprioli Consultant to Abbvie, MSD, Takeda, Janssen, Roche, Celgene, Bristol-Meyers Squibb, Galapagos, Gilead, Pfizer, Mundipharma, Galapagos, Biogen, Ferring, Eli-Lilly, Nestlè. Lecture fees from Abbvie, Ferring, Takeda, Allergy Therapeutics, Janssen, Pfizer, Biogen, Sandoz, Tillotts Pharma. Unrestricted research grants from Giuliani, Sofar, MSD, Takeda, Abbvie, Celltrion, Pfizer. Gian Paolo Caviglia Nothing to declare.