P0660Efficacy and safety of vedolizumab in early Crohn’s Disease: final results from the prospective, multicenter, interventional EARLY CD study

Background Early intervention with advanced therapies in patients (pts) with Crohn’s disease (CD) is associated with reduced complications and improved clinical outcomes.1,2 This study evaluated the efficacy and safety of vedolizumab (VDZ) in pts with early CD. Methods EARLY CD is a prospective, single-arm, multicentre, interventional study (ChiCTR2200063233) in pts who were diagnosed with CD within 18 months, had moderate-to-severe disease activity, and no prior exposure to disease-modifying agents (immunosuppressants, biologics or small molecule agents). Pts received VDZ treatment up to 50 weeks [W]). Clinical remission (CDAI ≤ 150) and endoscopic remission (SES-CD ≤ 4, or 2 with isolated ileal disease, assessed by colonoscopy) at W52 were primary endpoints. Secondary endpoints included clinical/endoscopic response, pt-reported outcomes, and quality of life (QoL). Safety outcomes were also assessed. Results Overall, 172 pts were enrolled (mean age: 30.9 years); most (73.8%) were male. The majority of patients were diagnosed with ileo-colonic CD (67.4%), and 64.5% of patients had inactive perianal fistulizing disease (Table 1). At week 14, clinical and endoscopic remission rates in the intent-to-treat (ITT) population (n = 172) were 81.7% and 49.1%, respectively; by week 52, clinical and endoscopic remission rates reached 67.1% and 47.0%. For the per-protocol(PP) population (n = 114), clinical and endoscopic remission rates improved from 93% and 62.3% at week 14 to 96.5% and 66.7% at week 52 (Figure 1). In the PP population, mucosal healing rate reached 42.5%, 50%, and 52.6% at week 14, week 26 and week 52, respectively, with deep remission (both clinical and endoscopic remission) reaching 66.7% at week 52. Early improvement was observed, with both abdominal pain score decreased by 55% and loose stool frequency score decreased by 60% on week 1. The IBDQ score improved with a mean (SD) change from baseline of 22.3 (27.3), 27.3 (30.8) and 26.1 (36.8) at W14, W26, and W52, respectively. Improvements in Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scores were observed with a mean (SD) change from baseline of 4.9 (9.18) at W26 and 4.7 (11.24) at W52. Overall, 34 adverse events were reported among 31 patients, 35.3% (12/34) were exacerbation of perianal disease, 20.6% (7/34) were infection, 11.8%(4/34) were bowel obstruction, and 17.6% (6/34) were arthralgia. Conclusion In pts with early CD, VDZ as an initial advanced therapy demonstrated high clinical and endoscopic remission rates in the long term, as well as early improvements in symptoms and quality of life. No new safety signals were observed. These findings from the EARLY CD study support the use of VDZ for early intervention in pts with CD. References: 1. Revés J, Mascarenhas A, José Temido M, et al. J Crohns Colitis. 2023;17(11):1752–1760. 2. Law CCY, Tkachuk B, Lieto S, et al. Inflamm Bowel Dis. 2024;30(7):1080–1086. Conflict of interest: Dr. Liu, Jing: Jing Liu has received honoraria payment from Takeda. Guo, Hong: No conflict of interest Zhu, Liangru: No conflict of interest Li, Yuqin: No conflict of interest Jia, Yan: No conflict of interest Zhang, Hongjie: No conflict of interest Zhang, Heng: No conflict of interest Huang, Qin: No conflict of interest Gao, Xiang: No conflict of interest Cao, Qian: No conflict of interest