PMID- 36799155
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231103
IS  - 1502-7708 (Electronic)
IS  - 0036-5521 (Linking)
VI  - 58
IP  - 8
DP  - 2023 Jul-Dec
TI  - Switching from intravenous to subcutaneous vedolizumab maintenance treatment in 
      patients with inflammatory bowel disease followed by therapeutic drug monitoring.
PG  - 863-873
LID - 10.1080/00365521.2023.2176252 [doi]
AB  - OBJECTIVE: Vedolizumab (VDZ) for subcutaneous (SC) administration has recently 
      become available. We aimed to assess feasibility, safety and clinical outcome 
      when switching from intravenous (IV) to SC VDZ maintenance treatment in a real 
      world cohort of patients with inflammatory bowel disease (IBD) followed by 
      therapeutic drug monitoring (TDM). METHODS: Eligible IBD patients were switched 
      from IV to SC treatment and assessed six months prior to switch, at baseline and 
      six, twelve and twenty-six weeks after switch. Primary outcome was proportion of 
      patients on SC treatment after 26 weeks. Secondary outcomes included adverse 
      events (AEs), clinical disease activity, biochemical markers, treatment interval, 
      serum-VDZ (s-VDZ), preferred route of administration and health-related quality 
      of life. RESULTS: In total, 108 patients were switched. After 26 weeks, 100 
      patients (92.6%) were still on SC treatment and median s-VDZ was 47.6 mg/L (IQR 
      41.3 - 54.6). The most frequent AE was injection site reaction (ISR), reported by 
      20 patients (18.5%). There were no clinically significant changes in disease 
      activity, biochemical markers and quality of life. The proportion of patients 
      preferring SC administration increased from 28.0% before switch to 59.4% after 
      26 weeks (p < 0.001). CONCLUSIONS: Nine out of ten patients still received SC 
      treatment after 26 weeks. No change in disease activity occurred, and levels of 
      serum VDZ increased. Although almost one fifth of patients experienced ISRs, a 
      higher proportion favored SC administration at 26 weeks. This study demonstrates 
      that SC maintenance treatment is a safe and feasible alternative to IV treatment.
FAU - Wiken, Thea H
AU  - Wiken TH
AUID- ORCID: 0000-0002-9858-9057
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
FAU - Hoivik, Marte L
AU  - Hoivik ML
AUID- ORCID: 0000-0002-0104-465X
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
FAU - Buer, Lydia
AU  - Buer L
AUID- ORCID: 0000-0002-5942-9202
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
FAU - Warren, David J
AU  - Warren DJ
AD  - Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, 
      Oslo, Norway.
FAU - Bolstad, Nils
AU  - Bolstad N
AD  - Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, 
      Oslo, Norway.
FAU - Moum, Bjorn A
AU  - Moum BA
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
FAU - Anisdahl, Karoline
AU  - Anisdahl K
AUID- ORCID: 0000-0003-2041-9100
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
FAU - Smastuen, Milada C
AU  - Smastuen MC
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
AD  - Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.
FAU - Medhus, Asle W
AU  - Medhus AW
AUID- ORCID: 0000-0001-7118-5127
AD  - Departement of Gastroenterology, Oslo University Hospital, Oslo, Norway.
AD  - Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
LA  - eng
PT  - Journal Article
DEP - 20230217
PL  - England
TA  - Scand J Gastroenterol
JT  - Scandinavian journal of gastroenterology
JID - 0060105
RN  - 9RV78Q2002 (vedolizumab)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Biomarkers)
SB  - IM
MH  - Humans
MH  - Drug Monitoring
MH  - Quality of Life
MH  - Gastrointestinal Agents/adverse effects
MH  - *Inflammatory Bowel Diseases/drug therapy/chemically induced
MH  - Biomarkers
MH  - Treatment Outcome
MH  - *Colitis, Ulcerative/drug therapy
OTO - NOTNLM
OT  - Crohn's disease
OT  - Inflammatory bowel disease
OT  - therapeutic drug monitoring
OT  - ulcerative colitis
OT  - vedolizumab
EDAT- 2023/02/18 06:00
MHDA- 2023/02/18 06:01
CRDT- 2023/02/17 04:33
PHST- 2023/02/18 06:01 [medline]
PHST- 2023/02/18 06:00 [pubmed]
PHST- 2023/02/17 04:33 [entrez]
AID - 10.1080/00365521.2023.2176252 [doi]
PST - ppublish
SO  - Scand J Gastroenterol. 2023 Jul-Dec;58(8):863-873. doi: 
      10.1080/00365521.2023.2176252. Epub 2023 Feb 17.