P1088Real-world treatment patterns and administration choices in patients with Inflammatory Bowel Disease receiving vedolizumab: Findings from the VARIETY – Croatia and Slovenia study

Background Intravenous (IV) and subcutaneous (SC) formulations of vedolizumab (VDZ) are established advanced treatment (Tx) options for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD).1 Real-world data comparing Tx patterns and patient (pt) preference of IV vs SC VDZ maintenance Tx (mTx) in pts with inflammatory bowel disease are scarce. Methods A prospective, observational, multicentre study (VARIETY; NCT04885920), conducted per an umbrella protocol, enrolled pts with UC or CD from Croatia and Slovenia (Feb 2022-Mar 2024). Eligible adults were either initiating or on ongoing VDZ induction (VDZ induction) or receiving IV VDZ mTx with an option to transition to SC VDZ mTx (VDZ mTX). The primary endpoint was real-world VDZ Tx patterns, including Tx persistence. Tx changes, discontinuation rates, pt and physician satisfaction, and safety were also assessed. Descriptive statistics were used. Results Of the 120 pts enrolled and who received VDZ, 82 (68%) were enrolled on VDZ mTx (UC, 37; CD, 45) and 38 (32%) on VDZ induction (UC, 22; CD, 16). Baseline pt characteristics are shown in Table 1. Overall, 81 (68%; UC, 37; CD, 44) pts remained on IV VDZ (IV-only) and 39 (33%; UC, 22; CD, 17) transitioned to SC VDZ (IV-SC; 4% of whom transitioned back to IV). Overall, 31% of ileocolonic CD pts, 30% with non-stricturing non-penetrating CD, 41% with extensive colitis, and 38% with proctitis transitioned to SC VDZ mTx, declaring a preference for SC VDZ, likely due to convenience and less discomfort. At week (W) 52, Tx persistence was 58% (UC, 16; CD, 6) with VDZ induction and 77% (UC, 26; CD, 37) with VDZ mTx and was similar between IV-only and IV-SC groups (Figure 1). During the study, 40 (33%) pts discontinued Tx, with higher discontinuation rates in VDZ induction (42%) vs VDZ mTx (29%) and in IV-SC (39%) vs IV-only (31%). Formulation change from IV to SC (32%) was the most frequent Tx change. The median time to start SC therapy was 42 days. At W52, the overall mean (standard deviation) pt Tx Satisfaction Questionnaire for Medication score was 48 (7) out of 59. At W52, 41% and 63% of physicians were extremely satisfied with VDZ Tx and local injection site tolerability, respectively. No dissatisfaction with local injection site tolerability was reported. Overall, 8 (7%; UC, 4; CD, 4) pts reported VDZ-related adverse events (AEs), including 2 serious AEs (upper respiratory tract infection and erythema). Conclusion Overall, Tx persistence, adherence, and clinical outcomes were comparable between the IV-only and IV-SC mTx groups, underscoring the importance of pt preference in Tx routes. SC VDZ has the potential to enhance pt satisfaction and adherence. No new safety signals were identified. Reference: 1. European Medicines Agency. Entyvio: EPAR - Product Information. https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio#product-info. Accessed September 16, 2025. Conflict of interest: Drobne, David: Speaker, consultant, and/or advisory board member for MSD, Abbvie, Takeda, Pfizer, Janssen, Krka, Eli Lilly, Oktal Pharma, Roche, Novartis, Amgen, and Lek. Ocepek, Andreja: Speaker for Abbvie, Abbott, Amgen, Biogen, Eli Lilly, EwoPharma, Ferring Pharmaceuticals, Genessis Biopharma SL, Johnson & Johnson, Krka, Lek, Mediasi, Medis, MSD, Mylan Helathcare, OPH Oktal Pharma, PharmaSwiss, Pontus Pharma, Pfizer, Shire, Stada, Swedish Orphan Biovitrum, Takeda Advisory Board member for Eli Lilly, Johnson & Johnson, Takeda Sibli, Renata: Lecturer or consultant for the companies Abbvie, Takeda, Pfizer, Janssen, Lek Borzan, Vladimir: Speaker honorarium: Sandoz Advisory board participation: Ely Lilly Brozović, Boris: Abbott, AbbVie, Berlin-Chemie, Elly Lilly, Fresenius Kabi, Krka, Oktal Pharma, Sandoz, Sobi, Takeda Tomasic, Vedran: Received a speaker honorarium from Takeda Pharmaceuticals Croatia d.o.o. Šiprak Stastny, Ana: Takeda Pharmaceuticals Croatia d.o.o. Ursic, Viktor: Takeda Pharmaceuticals d.o.o. Krznarić, Željko: Speakers honoraria (Abbott, Abbvie, Biocon, Celltrion/ Octal Pharma, Fresenius, Eli Lilly, Pharmas, Pfizer, Sobi, Takeda, Nestle, Nutricia, Baxter, Janssen, MSD). Advisory boards.