Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases
IBD center Amsterdam and the Dutch Initiative on Crohn and Colitis
(2022) Alimentary Pharmacology & Therapeutics, volume 56, issue 6, pp. 1044 - 1054
(Article)
Abstract
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
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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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Keywords: inflammatory bowel disease, real-world evidence, subcutaneous vedolizumab, Gastroenterology, Pharmacology (medical), Hepatology, Journal Article
ISSN: 0269-2813
Publisher: Wiley-Blackwell
Note: Funding Information: A.V., T.S., A.S., A.L.: none. M.D.: reports advisory fees from Echo Pharma and Robarts Clinical Trials, Inc., speaker fees from Janssen, Merck & Co., Inc., Pfizer, Takeda and Tillotts Pharma, and nonfinancial support from Dr. Falk Pharm. F.S: Advisory Boards Takeda, Galapagos. K.G.: has received grants from Pfizer Inc. and Celltrion; consultancy fees from AbbVie, Arena Pharmaceuticals, Galapagos, Gilead, ImmunicTherapeutics, Janssen Pharmaceuticals, Novartis, Pfizer Inc., Samsung Bioepis and Takeda; and speaker's honoraria from Celltrion, Ferring, Janssen Pharmaceuticals, Novartis, Pfizer Inc., Samsung Bioepis, Takeda and Tillotts. C.P.: received grants or contracts from Takeda, Pliant, and Gilead Sciences; consulting fees from Pliant and Shire (Takeda); and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Takeda, Tillotts Pharma, and Pfizer outside of the submitted work. J.G.: has served as a speaker for: Dr. Falk, GlaxoSmithKline, Janssen‐Cilag. J.H.: speaker's fees from Abbvie, Janssen, Takeda; consulting fees from Alimentiv Inc. G.T.: none. J.J.: has served on advisory boards and as a speaker or consultant for Abbvie, Amgen, Ferring, Fresenius, Janssen, MSD, Pfizer, Takeda. A.G.L. F.H.: Frank Hoentjen has served on advisory boards and as a speaker for Abbvie, Janssen‐Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk Funding (Grants/Honoraria): Takeda, Janssen‐Cilag, Abbvie Consulting Fees: Celgene. N.B.: has served as a speaker for AbbVie and MSD and has served as a consultant and/or principal investigator for TEVA Pharma BV and Takeda. He has received a [unrestricted] research grant from Dr. Falk, TEVA Pharma BV, MLDS and Takeda. All outside the submitted work. G.Dijkstra.: has received speakers fees from Janssen‐Cilag, Pfizer, Takeda and Abbvie. B.O.: has served as speaker for Galapagos, MSD, Janssen and received unrestricted grants from Takeda, Pfizer, Galapagos, Ferring, Celltrion and Abbvie. M.L.: has served as a speaker and/or principal investigator for: Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen‐Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Takeda, Tillotts, Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Achmea healthcare, Galapagos and ZonMW. A.M.: has served as speaker for: Galapagos, Janssen‐Cilag, Takeda, Tramedico. She has received research grants from Cablon, Galapagos, Nestle, Norgine and ZonMW. G.D.: Consultancy for Abbvie, Agomab, AstraZeneca, AM Pharma, AMT, Arena Pharmaceuticals, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Index Pharmaceuticals, Kaleido, Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Origo, Polpharma, Procise Diagnostics, Prometheus laboratories, Prometheus Biosciences, Progenity, Protagonist. Speaker's bureau for Abbvie, Arena, Galapagos, Gilead, Pfizer, BMS, Takeda. Publisher Copyright: © 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
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