Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases.
inflammatory bowel disease
real-world evidence
subcutaneous vedolizumab
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
revised:
16
05
2022
received:
26
04
2022
accepted:
07
07
2022
pubmed:
24
7
2022
medline:
25
8
2022
entrez:
23
7
2022
Statut:
ppublish
Résumé
Subcutaneous (SC) vedolizumab is effective in inflammatory bowel diseases (IBD) when administered after induction with two infusions. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 35869807
doi: 10.1111/apt.17153
pmc: PMC9540102
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Gastrointestinal Agents
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1044-1054Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
Références
BioDrugs. 2018 Oct;32(5):425-440
pubmed: 30043229
J Crohns Colitis. 2019 Aug 14;13(8):963-969
pubmed: 31087100
Clin Pharmacol Ther. 2020 May;107(5):1189-1199
pubmed: 31677154
N Engl J Med. 2013 Aug 22;369(8):699-710
pubmed: 23964932
N Engl J Med. 2013 Aug 22;369(8):711-21
pubmed: 23964933
J Crohns Colitis. 2019 Aug 14;13(8):970-975
pubmed: 30698684
J Control Release. 2018 Sep 28;286:301-314
pubmed: 30077735
J Crohns Colitis. 2022 Jan 28;16(1):27-38
pubmed: 34402887
Aliment Pharmacol Ther. 2022 Sep;56(6):1044-1054
pubmed: 35869807
Aliment Pharmacol Ther. 2022 Jun;55(11):1389-1401
pubmed: 35470449
BMC Gastroenterol. 2010 Jan 10;10:1
pubmed: 20064220
Clin Gastroenterol Hepatol. 2018 Dec;16(12):1937-1946.e8
pubmed: 29704680
Drug Metab Dispos. 2014 Nov;42(11):1881-9
pubmed: 25100673
Gut. 2019 Jan;68(1):25-39
pubmed: 29730603
Ir J Med Sci. 2019 Aug;188(3):821-834
pubmed: 30467804
Inflamm Bowel Dis. 2012 Aug;18(8):1523-30
pubmed: 21987429
Gastroenterology. 2020 Feb;158(3):562-572.e12
pubmed: 31470005
J Crohns Colitis. 2016 Dec;10(12):1437-1444
pubmed: 27252400
Aliment Pharmacol Ther. 2019 Jul;50(1):40-53
pubmed: 31165509
J Crohns Colitis. 2022 Jul 14;16(6):911-921
pubmed: 34935945
Scand J Gastroenterol. 2017 Jun - Jul;52(6-7):722-729
pubmed: 28362144
Gastroenterology. 2019 Oct;157(4):997-1006.e6
pubmed: 31175865