Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct 16:17:17562848241290636.
doi: 10.1177/17562848241290636. eCollection 2024.

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

Péter Bacsur  1   2 , Tamás Resál  1 , Patrícia Sarlós  3 , Ákos Iliás  4 , Liza Dalma Sümegi  4 , Diána Kata  5 , Anett Dávid  1 , Bernadett Farkas  1 , Emese Ivány  1 , Anita Bálint  1 , Zsófia Bősze  1 , Anna Fábián  1 , Renáta Bor  1 , Zoltán Szepes  1 , Waqqas Afif  6 , Talat Bessissow  6 , Klaudia Farkas  7   8 , Péter L Lakatos  9   10 , Tamás Molnár  7
Affiliations

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

Péter Bacsur et al. Therap Adv Gastroenterol. .

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.

PubMed Disclaimer

Conflict of interest statement

K.F. has received speaker’s honoraria from AbbVie, Janssen, Ferring, Takeda, and Goodwill Pharma. P.L.L. has been a speaker and/or advisory board member: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Gilead, Janssen, Eli Lilly, Merck, Organon, Pendopharm, Pfizer, Roche, Sandoz, and Takeda and has received unrestricted research grant: Gilead, Pfizer, and Takeda. T.M. has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, MundiPharma, Phytotec, Roche, Fresenius, and Teva. P.B., T.R., P.S., Á.I., L.D.S., D.K., A.D., B.F., E.I., A.B., Z.S.B., A.F., R.B., Z.S.Z., W.A., and T.B. have no conflict of interest to disclose.

Figures

Figure 1.
Figure 1.
Kaplan–Meier survival characteristics of the patients. The solid line represents the CD patients, while the dashed line represents the UC patients (p = 0.255). CD, Crohn’s disease; UC, ulcerative colitis.
Figure 2.
Figure 2.
The proportion of patients achieving biochemical (CRP < 5 mg/mL) and corticosteroid-free clinical (HBI <5, pMayo <3) remission at the baseline and by week 52. CRP, C-reactive protein; HBI, Harvey-Bradshaw Index; w52, week 52; p, significance level.
Figure 3.
Figure 3.
Serum VDZ levels of the patients by week 52. In both the CD and UC groups, the serum VDZ levels increased by w52 (p = 0.047 and p = 0.001). CD, Crohn’s disease; UC, ulcerative colitis; VDZ, vedolizumab; w52, week 52.
See this image and copyright information in PMC

References

    1. Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol 2014; 20(1): 91–99. - PMC - PubMed
    1. Burisch J, Jess T, Martinato M, et al.. The burden of inflammatory bowel disease in Europe. J Crohns Colitis 2013; 7(4): 322–337. - PubMed
    1. Singh S, Murad MH, Fumery M, et al.. First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis. Clin Gastroenterol Hepatol 2020; 18(10): 2179–2191.e6. - PMC - PubMed
    1. Turner D, Ricciuto A, Lewis A, et al.. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021; 160(5): 1570–1583. - PubMed
    1. Sandborn WJ, Feagan BG, Rutgeerts P, et al.. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013; 369(8): 711–721. - PubMed

LinkOut - more resources