DOP008 High clinical and endoscopic remission rate with Vedolizumab in early CD patients: the 2nd interim analysis from a prospective multicenter interventional Study (EARLY CD)

Abstract Background Early treatment with advanced therapy prior to the development of complications such as stricture and fistula, is associated with better disease prognosis in patients (pts) with Crohn’s disease (CD). This study (EARLY CD) aims to evaluate the efficacy and safety of Vedolizumab (VDZ) as first line therapy in pts with early CD. Methods EARLY CD is a prospective, single-arm, multicenter, interventional study (ChiCTR2200063233). Target enrollment was 172 pts and all pts will receive up to 50 weeks of VDZ treatment with dose optimization (additional dose at week 10 if no clinical response, and switch to Q4W if secondary loss of response at maintenance). Main inclusion criteria for early CD are disease duration less than 18 months, no previous use of immunosuppressive agents and advanced treatment, no complications such as fistula or stricture (except for inactive perianal fistula). Primary endpoint was clinical and endoscopic remission at week 52, together with several secondary endpoints including clinical and endoscopic response, transmural healing assessed by MRE, and improvements in both PRO and QoL. This second interim analysis was conducted when all 172 enrollments were completed. Results 172 pts were recruited with a median follow-up of 7.1 months (IQR 3.3-11.7). Mean age was 30.9 years, 73.8% were male. Mean CDAI score at baseline was 245.97 and SES-CD score was 9.7 (table). Clinical and endoscopic remission rates reached 83.8% and 48.7% at week 14, with further increase to 92.1% and 71.1% at week 52 (figure). Early clinical improvement was observed, with both abdominal pain score (APS) and loose stool frequency score (LSFS) started to decline from week 1, APS decreased by 50.6% (from 44.9 to 22.2), LSFS decreased by 56.1% (from 32.5 to 14.26). From week 1 to week 52, IBDQ improved from 157.8 to 185.9, self-rated health status EQ visual analogue scale increased from 72.3 to 85.4, and self-reported fatigue score assessed by FACIT improved from 38.1 to 43.9. Twenty pts have completed MRE evaluation both at baseline and week 52, with MaRIA score showing a decline from 23.9 to 20.3. Adverse events occurred among 20 pts (11.6%), including exacerbation of perianal disease that required surgical drainage (n=6), arthralgia (n=4), infection (n=7), GI bleeding (n=1), acute appendicitis (n=1), and elevated transaminase (n=1). Conclusion This is the first study worldwide to prospectively evaluate the efficacy of VDZ as first-line therapy among bio-naïve pts with early CD. Interim analysis showed promising results including high clinical and endoscopic remission rates through week 52, together with early PRO response and improvement in quality of life.