Outcomes of treatment cessation after switching to subcutaneous vedolizumab treatment in inflammatory bowel diseases

Péter Bacsur; Tamás Resál; Patrícia Sarlós; Ákos Iliás; Liza Dalma Sümegi; Diána Kata; Anett Dávid; Bernadett Farkas; Emese Ivány; Anita Bálint; Zsófia Bősze; Anna Fábián; Renáta Bor; Zoltán Szepes; Waqqas Afif; Talat Bessissow; Klaudia Farkas; Péter L Lakatos; Tamás Molnár

doi:10.1177/17562848241290636

Outcomes of treatment cessation after switching to subcutaneous vedolizumab treatment in inflammatory bowel diseases

Therap Adv Gastroenterol. 2024 Oct 16:17:17562848241290636. doi: 10.1177/17562848241290636. eCollection 2024.

Authors

Péter Bacsur^{1

2}, Tamás Resál¹, Patrícia Sarlós³, Ákos Iliás⁴, Liza Dalma Sümegi⁴, Diána Kata⁵, Anett Dávid¹, Bernadett Farkas¹, Emese Ivány¹, Anita Bálint¹, Zsófia Bősze¹, Anna Fábián¹, Renáta Bor¹, Zoltán Szepes¹, Waqqas Afif⁶, Talat Bessissow⁶, Klaudia Farkas^{7

8}, Péter L Lakatos^{9

10}, Tamás Molnár⁷

Affiliations

¹ Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
² HCEMM-USZ Translational Colorectal Research Group, Szeged, Hungary.
³ Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.
⁴ Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary.
⁵ Institute of Laboratory Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
⁶ Division of Gastroenterology, McGill University Health Center, Montreal, QC, Canada.
⁷ Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Kálvária Avenue 57, Szeged H-6725, Hungary.
⁸ HCEMM-USZ Translational Colorectal Research Group, Szeged, H-6728, Hungary.
⁹ Division of Gastroenterology, McGill University Health Centre, Montreal General Hospital, 1650 Avenue Cedar, D7-201, Montreal, QC H3G 1A4, Canada.
¹⁰ Department of Internal Medicine and Oncology, Semmelweis University, Koranyi S 2A, Budapest H-1083, Hungary.

Abstract

Background: The usability of subcutaneous vedolizumab (s.c. VDZ) treatment in inflammatory bowel diseases (IBD; ulcerative colitis (UC), Crohn's disease (CD)) has been proven via clinical trials while real-world data collection is ongoing.

Objectives: Our study evaluates the effectiveness, safety, patients' preferences, and psychological factors associated with s.c. VDZ treatment, after switching from intravenous (i.v.) formulation.

Design: Prospective, multicenter cohort study including IBD patients switching from i.v. VDZ to s.c. treatment and were evaluated over 52 weeks.

Methods: Serum VDZ levels and C-reactive protein (CRP) were measured at the baseline and w52. At w12, a questionnaire on the patient's satisfaction and psychological characteristics was administered. The primary outcome was the drug persistence rate (cessation was due to loss of response (LOR), adverse events, patient request, and other causes) at w52, while the secondary outcomes were the changes in the clinical corticosteroid-free remission (CSFR) and biochemical remission (BR; CRP ⩽ 5 mg/L) rates, safety issues, serum drug levels, patients' preferences, and psychological features.

Results: In total, 70 IBD patients were evaluated (32 CD patients, 38 UC patients; male/female ratio: 41.4%; median age: 43.2 years). In the CD group, 81.3% were in CSFR and 65.6% were in BR, while in the UC group, 71.7% were in CSFR and 69.4% were in BR. Overall, 17.1% of the patients ceased s.c. VDZ treatment after a median of 26.2 (interquartile range 20-47) weeks. LOR was registered in 3/12 ceased patients. In addition, CSFR and BR rates were stable, while serum VDZ levels increased by w52 (p < 0.001).

Conclusion: The transition from i.v. to s.c. VDZ treatment was effective, the overall persistence rate was associated with high serum drug levels, and no novel safety issues were reported. Although s.c. administration after induction can save resources, some patients still insisted on i.v. VDZ treatment, due to its proven formulation.

Keywords: Crohn’s disease; IBD; patient experience; subcutaneous vedolizumab; switching; ulcerative colitis.