P0672Persistence of Vedolizumab after switching to the subcutaneous route: results from the national French cohort study DOPER

Abstract Background Vedolizumab (VDZ) has been available in France as a subcutaneous formulation for the treatment of inflammatory bowel diseases (IBD) since 2021. The aim of this study was to evaluate the persistence, efficacy and tolerance of subcutaneous VDZ (SC-VDZ) after switching from intravenous (IV) route. Methods All patients with ulcerative colitis (UC) or Crohn’s disease (CD) in clinical remission for at least 3 months, who switched from IV-VDZ to SC-VDZ between February 2022 and April 2024, were included in a multicentric prospective French national cohort study. The date of the first SC-VDZ injection was the inclusion date. Clinical remission was defined as a partial Mayo score ≤ 2 in UC and a Harvey Bradshaw Index ≤ 4 in CD. Concomitant treatments (5-aminosalycilates, immunomodulators) were authorized at stable doses, whereas other advanced therapies were prohibited during the 12 months of the study. SC-VDZ was started at 108mg every other week. Primary endpoint was SC-VDZ persistence at week 54 (W54). Patients who had a disease-related surgery, repeated or prolonged ( 14 days) steroid courses and those who were lost to follow-up were considered non-persistent. Results A total of 337 patients were analyzed, after excluding 10 with active disease and one with an active infection at baseline: 246 (73%) UC patients (median disease duration: 7 years interquartile range: 4-17) and 91 (27%) CD patients (13 years 8-19). UC patients had been on IV-VDZ for a median duration of 1.4 years 0.4-3.4, vs 3.1 years 1.4-6.0 in CD patients. In the whole cohort, 205 patients (62%) were on a standard IV-VDZ regimen (300 mg 8-weekly) prior to switch. At W54, SC-VDZ persistence was 84% 95% confidence interval: 80-88, without significant difference between UC and CD (p = 0.36). During the study period, 32 patients (10%) had a dose increase of SC-VDZ: 22 (9%) in UC and 10 (11%) in CD . Among them, 15 (48%) had been on a standard IV-VDZ regimen prior to switch, and six (19%) eventually stopped VDZ due to persistent loss-of-response despite dose increase. Three (9%) switched-back to IV-VDZ. In total, 16 (5%) patients switched-back to IV-VDZ (13 UC and 3 CD patients). Four months after the switch-back, 12/16 (75%) were still on IV-VDZ. Regarding tolerance, 183 patients (54%) reported at least one adverse event (AE), the most frequent being injection-site reaction (16%) and infections (13%). 25 AEs led to treatment discontinuation. 19 serious AEs were reported, among which only one acute diarrhoea potentially related to SC-VDZ without treatment discontinuation. Conclusion Within this multicentric cohort of IBD patients, the persistence at one year from switch of SC-VDZ was 84%, with a favourable security profile. Pharmacokinetic data are pending. Conflict of interest: Dr. Hupé, Marianne: Abbvie, Takeda, Johnson & Johnson, Celltrion Healthcare, Lilly, Amgen, Pfizer Mathieu, Nicolas: Abbvie, Alphasigma, Celltrion Healthcare, Galapagos, Janssen, Lilly, Pfizer, Takeda, lecture fees from Abbvie, Alfasigma/Galapagos, Celltrion Healthcare, Janssen, Lilly, Mayoli-Spindler, Pfizer, Takeda, and has received research funding from, Celltrion Healthcare, Lessaffre, Lilly, Takeda Amiot, Aurelien: Personal Fees: Abbvie, Fresenius-Kabi, Adacyte, Tillotts pharma, Janssen, Pfizer, Biogen, AMgen, Sandoz, Takeda, Galapagos, Eli Lilly Seksik, Philippe: Takeda, Janssen, Merck MSD, Biocodex, Ferring, Fresenius Kabi, Astellas, Amgen, Pfizer, Pilege and Abbvie Charkaoui, Maeva: TBC Gilletta de Saint Joseph, Cyrielle: Abbvie, AlfaSigma, Amgen, Celltrion, Ferring, Fresenius, Janssen, Lilly, Pfizer, Takeda and Tillots Serrero, Melanie: TBC Bouhnik, Yoram: TBC Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Roblin, Xavier: TBC Nancey, Stéphane: Abbvie, Takeda, Celltrion Healthcare, Pfizer, Galapagos, Johnson & Johnson, Lilly, Fresenius, Amgen, Medac, MSD Abitbol, Vered: Takeda, Amgen, Sandoz, Janssen, Celltrion, Pfizer, Alfasigma, Nordic Pharma, Abbvie, Lilly, Ferring Gornet, Jean-Marc: Abbvie, Amgen, Celltrion Healthcare, Fresenius-Kabi, Gilead, Janssen, Mylan, MSD, Takeda, Sanofi Céline, Montuclard: Abbvie Hebuterne, Xavier: Xavier Hébuterne reports clinical research funding from AbbVie, Abivax, Alphasigma, Arena Pharmaceuticals, Celgene, Eli Lilly, Enterome, Gilead, Janssen, InDex Pharmaceuticals, Pfizer, Roche, Salix, Sangamo, Takeda, Theravance, serving on advisory boards for AbbVie, Abivax, Arena Pharmaceuticals, Gilead, Janssen, Pfizer, Roche, Takeda, and participating in lectures and educational activities for AbbVie, Amgen, Baxter, Fresenius Kabi, Janssen, MSD, Mylan, Nutricia, Pfizer, Tillots, and Takeda. Paupard, Thierry: TBC Rouillon, Clea: Abbvie, Janssen, Biogen, Galapagos, Celltrion, Lilly Kaassis, Mehdi: No conflict of interest Andrau, Pierre: No conflict of interest Amil, Morgane: No conflict of interest Peyrin-Biroulet, Laurent: CONSULTING Abbvie, Abivax, Adacyte, Alimentiv, Alfasigma, Amgen, Apini, Banook, BMS, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, LifeMine, Medac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Par’ Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta, Ventyx. LECTURE Abbvie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots Vicaut, Eric: No conflict of interest Laharie, David: Personal Fees: Board, consulting and lecture fees from Abbvie, Alfasigma, Amgen, Biocon, Celltrion, Ferring, Fresenius-Kabi, Johnson & Johnson, Lilly, MSD, Pfizer, Sandoz and Takeda