Real-World Outcomes of Patients Starting Intravenous and Transitioning to Subcutaneous Vedolizumab in Inflammatory Bowel Disease.

Publisher: Springer Science + Business Media Country of Publication: United States NLM ID: 7902782 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2568 (Electronic) Linking ISSN: 01632116 NLM ISO Abbreviation: Dig Dis Sci Subsets: MEDLINE

Publication: 2005- : New York, NY : Springer Science + Business Media
Original Publication: New York, Plenum Pub. Corp.

Antibodies, Monoclonal, Humanized*/therapeutic use ; Antibodies, Monoclonal, Humanized*/administration & dosage ; Gastrointestinal Agents*/administration & dosage ; Gastrointestinal Agents*/therapeutic use ; Quality of Life* ; Colitis, Ulcerative*/drug therapy ; Crohn Disease*/drug therapy; Humans ; Female ; Male ; Adult ; Middle Aged ; Injections, Subcutaneous ; Treatment Outcome ; Administration, Intravenous ; Registries ; Inflammatory Bowel Diseases/drug therapy ; Leukocyte L1 Antigen Complex/analysis ; Sweden/epidemiology ; Drug Substitution ; Remission Induction

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.
(© 2024. The Author(s).)

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VedolizumabSC-4002 Takeda Pharmaceuticals AB

Keywords: Inflammatory bowel disease; Observational study; Real-world data; Vedolizumab

9RV78Q2002 (vedolizumab)
0 (Antibodies, Monoclonal, Humanized)
0 (Gastrointestinal Agents)
0 (Leukocyte L1 Antigen Complex)

Date Created: 20240418 Date Completed: 20240608 Latest Revision: 20240822

20240823

PMC11162360

10.1007/s10620-024-08422-9

38637457