P4280 - Efficacy and Safety of Vedolizumab in Early CD Patients: Interim Results From a Prospective, Single-Arm, Multicenter, Interventional Study

Jing Liu, MD¹, Yuqin Li, MD, PhD², Hong Guo, MD, PhD³, Yan Jia, MD, PhD⁴, Hongjie Zhang, MD, PhD⁵, Liangru Zhu, MD, PhD⁶, Xiang Gao, MD⁷, Heng Zhang, MD, PhD⁸, Qian Cao, MD, PhD^1
1Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; ²First Hospital of Jilin University, Jilin, Heilongjiang, China; ³Chongqing General Hospital, Chongqing University, Chongqing, Chongqing, China; ⁴Seventh Medical Center of PLA General Hospital, Beijing, Beijing, China; ⁵The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China; ⁶Union Hospital Tongji Medical College Huazhong University of Science & Technology, Wuhan, Hubei, China; ⁷The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China; ⁸The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Introduction: Crohn’s disease (CD) is a chronic progressive disease, early treatment with disease-modifying agents prior to the development of complications is associated with better disease prognosis. This study aims to evaluate the efficacy and safety of Vedolizumab (VDZ), a gut-selective biologic in patients (pts) with early CD.

Methods: This is a prospective, single-arm, multicenter, interventional study (ChiCTR2200063233). Major inclusion criteria included pts diagnosed with CD within 18 months, moderate to severe disease activity, and no previous exposure to disease modifying agents (immunosuppressants, biologics or small molecule agents). The targeted number of recruitment was 172 and all pts recruited will receive up to 50 weeks of VDZ with dose optimization (additional dose at week 10 if no clinical response, and switch to Q4W if secondary loss of response at maintenance). Primary endpoints include clinical and endoscopic remission at week 52, together with several secondary endpoints including early clinical response, clinical and endoscopic response at week 14 and week 26. This is the first interim analysis conducted when 50% of targeted enrollment completed week 14 follow-up.

Results: A total of 116 pts have been recruited from 2022 Dec to 2024 May (table for baseline), with a median follow-up of 7.1 months (IQR 3.3-11.7). Clinical remission was achieved among 81.5%, 82.0% and 84.6% of pts at week 14, 26 and 52, respectively. At week 14, 51.9% and 41.8% of pts reached endoscopic response and remission, which further increased to 66.0%, 54.0% at week 26 and 76.9%, 76.9% at week 52 (figure). Early clinical improvement was observed, as abdominal pain score and loose stool frequency score started to decline from week 1, and decreased by 35.3% and 39.0% at week 6, respectively. Six pts showed primary loss of response (LOR) at week 14 and 10 pts showed secondary LOR during maintenance. Adverse events occurred among 8 patients (6.9%), including exacerbation of perianal disease that required surgical drainage (4 pts), arthralgia (3 pts) and skin infection (1 pts).

Discussion: This is the very first study world-wide to prospectively evaluate the efficacy of VDZ as first-line therapy among bio-naïve early CD patients. Interim analysis showed promising results including a high endoscopic remission rate at week 52, together with early clinical response.



Disclosures:


Jing Liu, MD¹, Yuqin Li, MD, PhD², Hong Guo, MD, PhD³, Yan Jia, MD, PhD⁴, Hongjie Zhang, MD, PhD⁵, Liangru Zhu, MD, PhD⁶, Xiang Gao, MD⁷, Heng Zhang, MD, PhD⁸, Qian Cao, MD, PhD¹. P4280 - Efficacy and Safety of Vedolizumab in Early CD Patients: Interim Results From a Prospective, Single-Arm, Multicenter, Interventional Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.