Takeda Pharmaceutical Company Ltd. Shanghai, Shanghai, China (People's Republic)
Chao Kang, MD1, Zhong Jie, MD2, Li Xie, 3, Yaqiu Hu,4, Lauren Gianchetti, MPH5, Zaeem Khan, MPH6, Zeinab Farhat, PhD7, Pravin Kamble, PhD7, Gao Xiang, MD1 1The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China; 2Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, China; 3Takeda Pharmaceutical Company Ltd., Shanghai, Shanghai, China; 4Takeda Pharmaceutical Company, Shanghai, Shanghai, China; 5PPD, part of Thermo Fisher Scientific, Philadelphia, PA; 6PPD, part of Thermo Fisher Scientific, Toronto, ON, Canada; 7Takeda Pharmaceuticals, Cambridge, MA
Introduction: Vedolizumab (VDZ) is a gut-selective antilymphocyte trafficking humanized monoclonal antibody that has demonstrated efficacy and safety for the treatment of moderate-to-severe Crohn’s Disease (CD) in global clinical trials. VDZ was conditionally approved in 2020 in China for the treatment of moderate to severe CD. The goal of this study was to evaluate the real-world clinical effectiveness and safety of VDZ in patients (pts) with CD in China.
Methods: This was a multi-center, observational, retrospective medical chart review study in adult pts (≥18 years old) with active CD in China who initiated VDZ as any line of biologic treatment. Data were collected from VDZ treatment initiation to chart abstraction, treatment discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated using the Kaplan Meier method over 6, 18, and 30 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics data were also collected.
Results: In total, 131 Crohn’s disease pts who were treated with VDZ were included in the study. Baseline characteristics are shown in Table 1. Over 30 months, cumulative rates of clinical response and clinical remission were 69.6% and 46.8%, respectively and rates of mucosal healing and deep remission were 76.0% and 56.3%, respectively. The cumulative rate of treatment persistence over 30 months was 42.4%. The incidence rates per 100 patient-years was 4.73 (95% CI: 2.36, 9.45) for serious adverse events and 0.58 (95% CI: 0.08, 4.12) for serious infections. Incidence rates per 100 patient years for other outcomes were as follows: CD exacerbations 8.71 (95% CI: 5.16, 14.71), CD-related emergency department visits 1.17 (95% CI: 0.29, 4.66), and CD-related surgeries 5.49 (95% CI: 2.86, 10.55).
Discussion: VDZ is an effective and safe longer-term treatment in patients with CD in China. Results from this real-world study were consistent with results from previous global studies, supporting the effectiveness and safety of VDZ treatment across global regions.
Acknowledgements: Medical writing support was provided by Paul Hassan, PhD, of Excel Scientific Solutions, and funded by Takeda.
Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
Disclosures:
Chao Kang indicated no relevant financial relationships.
Zhong Jie indicated no relevant financial relationships.
Li Xie: Takeda China – Employee, Stock Options.
Yaqiu Hu: Takeda China – Employee, Stock Options.
Lauren Gianchetti: PPD, part of Thermo FIsher Scientific – Employee.
Zaeem Khan: PPD, part of Thermo FIsher Scientific – Employee.
Zeinab Farhat: Takeda – Employee, Stock Options.
Pravin Kamble: Takeda – Employee, Stock Options.
Gao Xiang indicated no relevant financial relationships.
Chao Kang, MD1, Zhong Jie, MD2,, Li Xie,3Yaqiu Hu, 4, Lauren Gianchetti, MPH5, Zaeem Khan, MPH6, Zeinab Farhat, PhD7, Pravin Kamble, PhD7, Gao Xiang, MD1. P0914 - Clinical Effectiveness and Safety of Vedolizumab in Patients With Crohn’s Disease in China: Results From a Real World Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
