P1071Comparison of effectiveness between Vedolizumab and Filgotinib in patients with ulcerative colitis previously exposed to at least one anti-TNF agent: Results from the real-world evidence multicenter VEDOFIL study

Abstract Background We aimed to compare the effectiveness of vedolizumab and filgotinib in patients with ulcerative colitis (UC) previously exposed to at least one anti-TNF agent. Methods This was a multicenter real-world evidence retrospective study that consecutively included all UC patients aged ≥18 years with symptomatic UC (partial Mayo score 2) who initiated vedolizumab (VDZ) or filgotinib (FLG) after prior exposure to at least one anti-TNF. VDZ was administered intravenously with induction at 300 mg at weeks 0, 2, and 6, and subsequent IV infusions every 4 or 8 weeks according to the investigator’s choice. FLG was prescribed at a unique dose of 200 mg orally once daily. The primary endpoint was symptomatic remission (partial Mayo score ≤2) without corticosteroids (CFREM) at week 16 (W16). Secondary endpoints were clinical remission per modified Mayo score, and histological and endoscopic improvement (HEMI). Comparisons were made using propensity-score analyses (IPTW) adjusted the usual potential confounders. Results Overall, 230 patients were included (151 in the VDZ group and 79 in the FLG group. The two groups were comparable except for higher proportion of patients with prior exposure to at least 2 biologics (36.1% vs 92.1%; p 0.001) in FLG group and concomitant corticosteroids (31.1% vs 19.0%) or an associated immunosuppressant (20.5% vs 0%) in VDZ group. After propensity adjustment, CFREM at W16 was achieved in 38.1% and 31.1% of patients in VDZ and FLG groups, respectively (p = 0.51). Subgroup analyses (after IPTW) showed that VDZ was more effective than FLG after failure of a single biologic (p 0.001), with no difference after two prior failures (OR = 2.05 0.36–11.71, p = 0.41), whereas FLG was more effective after failure of at least three prior biologics (OR = 10.4 1.1–102.4, p = 0.045). No predictor of FLG effectiveness was identified. Factors associated with absence of CFREM at W16 on VDZ were UC severity (p = 0.035), failure of ≥ 3 biologics (p = 0.013), and primary failure to at least one biologic (p = 0.013). No difference was observed between the two treatments regarding clinical remission and HEMI at W16 (p = 0.47 and 0.18, respectively). With a median follow-up of over 12 months, no significant differences were noted between the two treatments in time to treatment discontinuation, UC-related hospitalization, or colectomy. Conclusion In this real-world evidence study, VDZ appeared to be a more effective option than FLG as a second-line biologic (after anti-TNF failure), whereas FLG became a better option in third- or fourth-line of advanced therapies. These data may help physicians managing patients with UC to guide therapeutic decision-making. Conflict of interest: Prof. Dr. Buisson, Anthony: Consulting fees from: Abbvie, AlfaSigma, Amgen, Arena, Biogen, Celltrion, CTMA, Ferring, Galapagos, Guty Care, Janssen, Hikma, Lilly, Mylan, Nexbiome, Pfizer, Roche, Takeda, Tillotts Lecture fees from: Abbvie, AlfaSigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Hikma, Janssen, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma Research fundings from: Abbvie, AlfaSigma, Celltrion, Janssen, Lessaffre, Lilly, Pfizer, Takeda Bouguen, Guillaume: Grant: Abbvie, Ferisinus Personal Fees: Abbvie, Takeda, Fresinus, Amgen, Biogène, Arena, Ferring, Gilead, Janssen, MSD, Pfizer, Sandoz, Takeda, Tillots, Vifor pharma Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Uzzan, Mathieu: Grant: ECCO-IOIBD, Fondation pour la Recherche Medicale (FRM), SNFGE Personal Fees: Abbvie, Takeda, Celltrion, Janssen, Amgen, Alfasigma, Pfizer Domas, Quentin: No conflict of interest Serrero, Melanie: No conflict of interest Altwegg, Romain: Advisory boards from Abbvie, Takeda, Johnson and Johnson, Lilly, Alphasigma, Celltrion, Pfizer, Amgen, Biogen, Sandoz, Ferring Fumery, Mathurin: Grant: Pfizer Personal Fees: Abbvie, Janssen, Takeda, MSD, Biogen, Amgen, Sandoz, Fresenius, Gilead, Celgene, Galapagos, Mylan, Tillots, Ferring, Pfizer, Hospira, CTMA, Boehringer, Lilly, Arena Non-financial Support: Abbvie, Janssen, Takeda, MSD, Galapagos, Ferring, Pfizer Amiot, Aurelien: Personal Fees: Abbvie, Fresenius-Kabi, Adacyte, Tillotts pharma, Janssen, Pfizer, Biogen, AMgen, Sandoz, Takeda, Galapagos, Eli Lilly Caillo, Ludovic: Abbvie, Amgen, Celltrion, Ferring, Fresenius, Lilly, Jonhson&Jonhson, MSD, Pfizer, Takeda, Sandoz Hupé, Marianne: No conflict of interest Gilletta de Saint Joseph, Cyrielle: Speaker/ consultant fees from Abbvie, AlfaSigma, Amgen, Celltrion, Ferring, Fresenius, Janssen, Lilly, Pfizer, Takeda and Tillots Treton, Xavier: Personal Fees: Lectures and advisory board : Abbvie, Celltrion, MSD, johnson&Johnson, Takeda, Amgen, Alphasigma, Lilly, Pfizer Other: participations: Thabor Therapeutics Pereira, Bruno: No conflict of interest