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Real-World Outcomes of Patients Starting Intravenous and Transitioning to Subcutaneous Vedolizumab in Inflammatory Bowel Disease
School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
School of Health and Medical Sciences, Örebro University, Örebro, Sweden; Central Hospital in Karlstad, Karlstad, Sweden.
Department of Gastroenterology, Skåne University Hospital, Lund, Sweden; Department of Clinical Sciences, Lund University, Lund, Sweden.
Takeda Pharma, Medical Affairs, Stockholm, Sweden.
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2024 (English)In: Digestive Diseases and Sciences, ISSN 0163-2116, E-ISSN 1573-2568, Vol. 69, no 6, p. 2175-2183Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Real-world data on starting intravenous (IV) vedolizumab (VDZ) and transitioning to subcutaneous (SC) treatment in inflammatory bowel disease (IBD) are scarce. AIMS: To assess treatment outcomes of patients with IBD starting IV VDZ and switching to SC VDZ in routine clinical care.

METHODS: Adult patients with IBD switching from IV to SC VDZ treatment between 1 March 2020 and 31 December 2021 were identified from the Swedish IBD quality register. The primary outcome was SC VDZ persistence. Secondary outcomes included clinical remission, changes in quality of life (QoL) according to EuroQual 5-Dimensions 5-Levels (EQ-5D-5L) and the Short-Health Scale (SHS) and inflammatory markers, including faecal Calprotectin (FCP).

RESULTS: Altogether, 406 patients with IBD (Crohn's disease, n = 181; ulcerative colitis, n = 225) were identified. After a median follow-up of 30 months from starting IV VDZ treatment, the persistence rates were 98%(178/181) in Crohn's disease and 94% (211/225) in ulcerative colitis. Most patients (84%) transitioned during maintenance therapy, and the median follow-up from switch to SC VDZ was 10 months. Compared to baseline, statistically significant improvements were observed in all domains of the SHS, EQ-5D index value and visual analogue scale. Median (interquartile range) FCP concentrations (μg/g) decreased from 459 (185-1001) to 65 (26-227) in Crohn's disease (n = 45; p < 0.001) and from 646 (152-1450) to 49 (20-275) in ulcerative colitis (n = 58; p < 0.001).

CONCLUSION: Initiating IV VDZ and switching to SC treatment was associated with high persistence rates and improvements in measures of QoL and FCP. These findings are reassuring for patients who start IV VDZ and switch to SC VDZ.

Place, publisher, year, edition, pages
Kluwer Academic Publishers, 2024. Vol. 69, no 6, p. 2175-2183
Keywords [en]
Inflammatory bowel disease, Observational study, Real-world data, Vedolizumab
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-113317DOI: 10.1007/s10620-024-08422-9ISI: 001205450600005PubMedID: 38637457Scopus ID: 2-s2.0-85190691369OAI: oai:DiVA.org:oru-113317DiVA, id: diva2:1852761
Funder
Örebro UniversityRegion Örebro County
Note

Open access funding provided by Örebro University. This work was funded by Takeda Pharma AB (VedolizumabSC-4002); the Regional Agreement on Medical Training and Clinical Research between Region Örebro County and Örebro University: ALF (grant number OLL-836791 to CE). 

Available from: 2024-04-19 Created: 2024-04-19 Last updated: 2025-02-11Bibliographically approved

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Ludvigsson, Jonas F.Eriksson, CarlHalfvarson, Jonas

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