PMID- 35869807 OWN - NLM STAT- MEDLINE DCOM- 20220824 LR - 20231211 IS - 1365-2036 (Electronic) IS - 0269-2813 (Print) IS - 0269-2813 (Linking) VI - 56 IP - 6 DP - 2022 Sep TI - Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases. PG - 1044-1054 LID - 10.1111/apt.17153 [doi] AB - 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 mug/ml at the time of the switch to 31 mug/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. CI - (c) 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. FAU - Volkers, Adriaan AU - Volkers A AUID- ORCID: 0000-0002-9547-1627 AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - Straatmijer, Tessa AU - Straatmijer T AUID- ORCID: 0000-0001-6989-5226 AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. AD - Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - Duijvestein, Marjolijn AU - Duijvestein M AD - Department of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands. FAU - Sales, Amber AU - Sales A AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - Levran, Amit AU - Levran A AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - van Schaik, Fiona AU - van Schaik F AD - University Medical Centre Utrecht, Utrecht, The Netherlands. FAU - Maljaars, Jeroen AU - Maljaars J AUID- ORCID: 0000-0003-0477-9499 AD - Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - Gecse, Krisztina AU - Gecse K AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - Ponsioen, Cyriel AU - Ponsioen C AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - Grootjans, Joep AU - Grootjans J AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - Hanzel, Jurij AU - Hanzel J AUID- ORCID: 0000-0003-3158-8014 AD - Department of Gastroenterology, UMC Ljubljana, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. FAU - Tack, Greetje AU - Tack G AD - Medical centre Leeuwarden, Leeuwarden, The Netherlands. FAU - Jansen, Jeroen AU - Jansen J AD - OLVG, Amsterdam, The Netherlands. FAU - Hoentjen, Frank AU - Hoentjen F AUID- ORCID: 0000-0001-5314-4452 AD - Department of Gastroenterology, Radboud University Medical Center, Nijmegen, The Netherlands. AD - Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Canada. FAU - de Boer, Nanne AU - de Boer N AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. FAU - van der Marel, Sander AU - van der Marel S AD - Haaglanden Medical Centre, The Hague, The Netherlands. FAU - Dijkstra, Gerard AU - Dijkstra G AD - University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands. FAU - Oldenburg, Bas AU - Oldenburg B AD - University Medical Centre Utrecht, Utrecht, The Netherlands. FAU - Lowenberg, Mark AU - Lowenberg M AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. FAU - van der Meulen, Andrea AU - van der Meulen A AD - Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - D Haens, Geert AU - D Haens G AD - Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. CN - IBD center Amsterdam and the Dutch Initiative on Crohn and Colitis LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220723 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Gastrointestinal Agents) RN - 9RV78Q2002 (vedolizumab) RN - Belonephobia SB - IM CIN - Aliment Pharmacol Ther. 2023 Mar;57(6):741-742. PMID: 36821749 CIN - Aliment Pharmacol Ther. 2023 Mar;57(6):743-744. PMID: 36821751 CIN - Aliment Pharmacol Ther. 2023 Jul;58(2):262-263. PMID: 37352154 MH - Antibodies, Monoclonal, Humanized MH - *Colitis, Ulcerative/chemically induced/drug therapy MH - *Crohn Disease/chemically induced/drug therapy MH - Gastrointestinal Agents/therapeutic use MH - Humans MH - *Inflammatory Bowel Diseases/drug therapy MH - Phobic Disorders MH - Prospective Studies MH - Remission Induction MH - Treatment Outcome PMC - PMC9540102 OTO - NOTNLM OT - inflammatory bowel disease OT - real-world evidence OT - subcutaneous vedolizumab COIS- 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. EDAT- 2022/07/24 06:00 MHDA- 2022/08/25 06:00 PMCR- 2022/10/07 CRDT- 2022/07/23 05:03 PHST- 2022/05/16 00:00 [revised] PHST- 2022/04/26 00:00 [received] PHST- 2022/07/07 00:00 [accepted] PHST- 2022/07/24 06:00 [pubmed] PHST- 2022/08/25 06:00 [medline] PHST- 2022/07/23 05:03 [entrez] PHST- 2022/10/07 00:00 [pmc-release] AID - APT17153 [pii] AID - 10.1111/apt.17153 [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2022 Sep;56(6):1044-1054. doi: 10.1111/apt.17153. Epub 2022 Jul 23.