Subcutaneous Vedolizumab Treatment in a Real-World Inflammatory Bowel Disease Cohort Switched From Intravenous Vedolizumab: Eighteen-Month Prospective Follow-up Study

Thea H Wiken; Marte L Høivik; Karoline Anisdahl; Lydia Buer; David J Warren; Nils Bolstad; Milada Hagen; Bjørn A Moum; Asle W Medhus

doi:10.1093/crocol/otae013

Subcutaneous Vedolizumab Treatment in a Real-World Inflammatory Bowel Disease Cohort Switched From Intravenous Vedolizumab: Eighteen-Month Prospective Follow-up Study

Crohns Colitis 360. 2024 Feb 26;6(1):otae013. doi: 10.1093/crocol/otae013. eCollection 2024 Jan.

Authors

Thea H Wiken^{1

2}, Marte L Høivik^{1

2}, Karoline Anisdahl^{1

2}, Lydia Buer¹, David J Warren³, Nils Bolstad³, Milada Hagen^{1

2

4}, Bjørn A Moum^{2

5}, Asle W Medhus^{1

2}

Affiliations

¹ Departement of Gastroenterology, Oslo University Hospital, Ullevål, Oslo, Norway.
² Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
³ Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Norway.
⁴ Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.
⁵ Department of FOU and Gastroenterology, Østfold Hospital Trust, Kalnes, Norway.

Abstract

Background: Vedolizumab has since 2021 been available as a subcutaneous formulation. We aimed to assess 18-month drug persistence and possible predictive factors associated with discontinuation, safety, serum drug profile, drug dosing, and disease activity in a real-world cohort of patients with inflammatory bowel disease switched from intravenous to subcutaneous vedolizumab maintenance treatment.

Methods: Eligible patients were switched to subcutaneous vedolizumab and followed for 18 months or until discontinuation of subcutaneous treatment. Data on preferred route of administration, adverse events, drug dosing, serum-vedolizumab, disease activity, fecal calprotectin, and C-reactive protein were collected. Persistence was described using Kaplan-Meier analysis. The impact of clinical and biochemical variables on persistence was analyzed with Cox proportional hazard models.

Results: We included 108 patients, and the estimated 18-month drug persistence was 73.6% (95% CI [64.2-80.1]). Patients in clinical remission at switch were less likely to discontinue SC treatment (HR = 0.34, 95% CI [0.16-0.73], P = .006), and patients favoring intravenous treatment at switch were almost 3 times more likely to discontinue (HR = 2.78, 95% CI [1.31-5.90], P = .008). Four patients discontinued subcutaneous vedolizumab due to injection site reactions. At 18 months, 88% of patients administered subcutaneous vedolizumab with an interval of ≥ 14 days, and serum-vedolizumab was 39.1 mg/L. Disease activity was stable during follow-up.

Conclusions: Three of the four patients remained on subcutaneous vedolizumab after 18 months, a large proportion received treatment at standard dosing intervals, and disease activity remained stable. This indicates that switching from intravenous to subcutaneous vedolizumab treatment is convenient and safe.

Keywords: Crohn’s disease; subcutaneous; therapeutic drug monitoring; ulcerative colitis; vedolizumab.