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Real-world experience of switching from intravenous to subcutaneous vedolizumab treatment

Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases.

Adriaan Volkers, Tessa Straatmijer, Marjolijn Duijvestein, Amber Sales, Amit Levran, Fiona van Schaik, Jeroen Maljaars, Krisztina Gecse, Cyriel Ponsioen, Joep Grootjans, Jurij Hanzel, Greetje Tack, Jeroen Jansen, Frank Hoentjen, Nanne de Boer, Sander van der Marel, Gerard Dijkstra, Bas Oldenburg, Mark Löwenberg, Andrea van der Meulen, Geert D Haens, IBD center Amsterdam and the Dutch Initiative on Crohn and Colitis

Published in Jul 2022, Alimentary pharmacology & therapeutics.


Summary


Background Subcutaneous (SC) vedolizumab is effective in inflammatory bowel diseases (IBD) when administered after induction with two infusions.


Aim To assess the effectiveness, safety and pharmacokinetics of a switch from intravenous (IV) to SC maintenance vedolizumab in patients with IBD.


Methods In this prospective cohort study, patients with IBD who had ≥4 months IV vedolizumab were switched to SC vedolizumab. We studied the time to discontinuation of SC vedolizumab, adverse events (AEs), changes in clinical and biochemical outcomes and vedolizumab concentrations at baseline, and weeks 12 and 24.


Results We included 82 patients with Crohn's disease (CD) and 53 with ulcerative colitis (UC). Eleven (13.4%) patients with CD and five (9.4%) with UC discontinued SC vedolizumab after a median of 18 (IQR 8–22) and 6 weeks (IQR 5–10), respectively. Four patients with CD switched to a different drug due to loss of response, nine switched back to IV vedolizumab due to adverse events, and three due to needle fear. Common AEs were injection site reactions (n = 15) and headache (n = 6). Median clinical and biochemical disease activity remained stable after the switch. Median serum vedolizumab concentrations increased from 19 μg/ml at the time of the switch to 31 μg/ml 12 weeks after the switch (p < 0.005).


Conclusions Switching from IV to SC vedolizumab maintenance treatment is effective in patients with CD or UC. However, 9% of patients were switched back to IV vedolizumab due to adverse events or fear of needles.



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