P0828Crohn’s disease patients respond better to vedolizumab if biologic-naïve

Abstract Background Vedolizumab is effective and safe for induction and maintenance of remission in Crohn’s disease, but responses vary widely (22-47% in mild-to-moderate disease)(1-3). Real-world, prospective data on the effectiveness of vedolizumab in biological-naive patients with Crohn’s disease is scarce. Here, we report the 1-year clinical outcomes from the prospective BullsEye study of vedolizumab response in both biologic-exposed and biologic-naïve patients. Methods This observational longitudinal multicentre study enrolled both anti-TNF therapy-naïve and -exposed Crohn’s disease patients and collected demographic and disease-specific characteristics at baseline. At fixed timepoints over a period of a year, Harvey-Bradshaw Index (HBI) and Simple Endoscopic Score for Crohn’s Disease (SES-CD) were scored. At baseline and 52 weeks a colonoscopy was performed, consistent with standard care. Response rates were defined as a reduction of the HBI of at least 3 points, or a HBI score lower than 4 at week 20. Endoscopic remission was defined as a SES-CD of 2 or lower. Results A total of 76 patients was enrolled, 57 biologic-naïve and 19 biologic-exposed. At 20 weeks, 58 patients (76.3%) responded, 47 out of 57(82.4%) versus 11 out of 19 (42.1%) of the biologic-naïve and exposed group, respectively. The mean HBI reduction in responders was 6.69 (SD 2.92) and in non-responders 0.636 (SD 1.86). Of the patients with a follow-up endoscopy at 52 weeks, 16/28 (57.1%) of the naïve and 3/8(37.5%) of the exposed patients showed endoscopic response. After 1 year, the drug survival was 84.2% in biologic-naïve versus 42.1% in biologic-exposed patients, regardless of clinical or endoscopic response. Conclusion Our study shows higher response rates and subsequent drug survival of vedolizumab in biologic-naïve patients in comparison to biologic-exposed patients. This study was sponsored by Takeda Pharmaceutical Company Limited. References: 1. Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel J-F, Sands BE, et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease. New England Journal of Medicine. 2013;369(8):711-21.4. 2. Dulai PS, Singh S, Jiang X, Peerani F, Narula N, Chaudrey K, et al. The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn’s Disease: Results From the US VICTORY Consortium. Am J Gastroenterol. 2016;111(8):1147-55.5. 3. Eriksson C, Rundquist S, Lykiardopoulos V, Udumyan R, Karlén P, Grip O, et al. Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study. Therapeutic Advances in Gastroenterology. 2021;14:175628482110233. Conflict of interest: Ms. Dijkstra, Sarah: My research is supported by a grant from Takeda Pharmaceutical Company Limited. Schultheiss, Johannes Paulus Damiaan: No conflict of interest Mares, Wout: Speaker fees from Janssen and advisory committee AbbVie, Ferring, and Takeda. Jharap, Bindia: No conflict of interest Horjus Talabur Horje, Carmen Simona: No conflict of interest Lutgens, Maurice: No conflict of interest van Wijk, Femke: Speaker and/or consultant for Janssen, Johnson & Johnson, and Takeda. She has received research funding from Leo Pharma, Takeda, Galapagos, Sanofi, and Bristol-Myers Squibb. She was co-applicant on an unrestricted Investigator Initiated Research Grant of Pfizer. Fidder, Herma: She has served as a speaker for both Janssen and Takeda. She has served as a consultant for Takeda, Galapagos, and Ferring. She has received a research grant from Takeda. Oldenburg, Bas: Unrestricted grants: Abbvie, Takeda, Pfizer, Galapagos Advisory boards: Abbvie, Takeda, Pfizer, Lilly, Galapagos, Janssen