P0826 Switching to standard-dose subcutaneous vedolizumab increases the percentage of patients in biochemical remission even in those intensified with intravenous vedolizumab: one year results of a Spanish multicentre observational study
Authors: Andres Pascual L , Iborra M , Vicente R , Arias L , Nos P , Royo-Esteban A , Sicilia B 
Published: January 2025

Abstract

Background
Analyse the percentage of subcutaneous drug persistence and pharmacokinetics in patients undergoing intravenous (iv) vedolizumab after switching to Subcutaneous (sc) vedolizumab. In addition, the relationship between treatment with intensified iv vedolizumab versus patients without intensification.

Methods
A multicentre, descriptive, observational, and retrospective study of a cohort of 54 patients diagnosed with Ulcerative Colitis (UC) and Crohn´s disease (CD) treated with iv vedolizumab, who underwent a switch to sc vedolizumab. Analyse clinical, biochemical, and analytical parameters; vedolizumab levels during follow-up and need for intensified intravenous treatment in patients on iv vedolizumab treatment and subsequent switch to sc vedolizumab with follow-up during weeks 4, 12, 24, and 52.

Results
32 patients (59%) had a diagnosis compatible with UC and 22 patients (41%) with CD. Biochemical remission was achieved in 32 patients (86%). All patients achieved clinical remission. In addition, a progressive increase in vedolizumab levels was evident after switching to sc vedolizumab with statistical significance (p&lt;0.05) during follow-up. Up to 14 patients (25.9%) were on an intensified regimen before switching to sc vedolizumab. All patients were maintained on sc vedolizumab at a dose of 108mg/2 weeks without requiring intensification at medical criteria during the one-year follow-up.

Conclusion
Up to 20% more patients, after switching from iv to sc vedolizumab, achieved biochemical remission, which was higher in the intensified group (34%), after one year of follow-up with a standard dose of sc vedolizumab.

References
1.Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colomben JF, Sands BE et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013 Aug 22;369(8):711-21.
2.Vermiere S, D’Haens G, Baert F, Danese S, Kobayashi T, Loftus EV et al. Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active Crohn’s Disease: results from the VISIBLE 2 randomised trial. J Crohns Colitis. 2022;16(1):27-38.
3.Buisson A, Serrero M, Orsat L, Nancey S, Rivière P, Altwegg R et al. Comparative Acceptability of Therapeutic Maintenance Regimens in Patients with Inflammatory Bowel Disease: Results from the Nationwide ACCEPT2 Study. Inflamm. Bowel Dis. 2023, 29, 579–588.
4.Bergqvist V, Holmgren J, Klintman D, Marsal J. Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2022 Jun;55(11):1389-1401.
5.Oršić Frič V, Borzan V, Šahinović I, Borzan A, Kurbel S. Real-World Study on Vedolizumab Serum Concentration, Efficacy, and Safety after the Transition from Intravenous to Subcutaneous Vedolizumab in Inflammatory. Bowel Disease Patients: Single-Center Experience. Pharmaceuticals (Basel). 2023 Feb 5;16(2):239.

Figure 1. vedolizumab levels.