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Volkers, A.; Straatmijer, T.; Duijvestein, M.; Sales, A.; Levran, A.; Schaik, F. van; ... ; Dutch Initiative Crohn Colitis (2022)

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

Article / Letter to editor
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 135 patients, 82 with Crohn's disease (CD) and 53 with ulcerative colitis (UC). Eleven (13.4%) CD and five (9.4%) UC patients discontinued SC vedolizumab after a median of 18 (IQR 8-22) and 6 weeks (IQR 5-10), respectively. Four patients (all CD) switched to a different drug due to loss of response, nine switched back to IV vedolizumab due to adverse events, and...Show moreBackground 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 135 patients, 82 with Crohn's disease (CD) and 53 with ulcerative colitis (UC). Eleven (13.4%) CD and five (9.4%) UC patients discontinued SC vedolizumab after a median of 18 (IQR 8-22) and 6 weeks (IQR 5-10), respectively. Four patients (all 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 vedolizumab serum concentrations increased from 19 mu g/ml at the time of the switch to 31 mu g/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.Show less
inflammatory bowel disease
real-world evidence
subcutaneous vedolizumab
All authors
Volkers, A.; Straatmijer, T.; Duijvestein, M.; Sales, A.; Levran, A.; Schaik, F. van; Maljaars, J.; Gecse, K.; Ponsioen, C.; Grootjans, J.; Hanzel, J.; Tack, G.; Jansen, J.; Hoentjen, F.; Boer, N. de; Marel, S. van der; Dijkstra, G.; Oldenburg, B.; Lowenberg, M.; Meulen, A. van der; D'Haens, G.; IBD Ctr Amsterdam; Dutch Initiative Crohn Colitis
Date
2022-07-23
Journal
Alimentary Pharmacology and Therapeutics
Volume
56
Issue
6
Pages
1044 - 1054
DOI
doi:10.1111/apt.17153
Link
https://onlinelibrary.wiley.com/doi/10.1111/apt.17153