1. Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial
- Author
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Liping Dou, Yanli Zhao, Jingjing Yang, Lei Deng, Nan Wang, Xiawei Zhang, Qingyang Liu, Yan Yang, Zhijie Wei, Fuxu Wang, Yifan Jiao, Fei Li, Songhua Luan, Liangding Hu, Sujun Gao, Chuanfang Liu, Xiangjun Liu, Jinsong Yan, Xuejun Zhang, Fang Zhou, Peihua Lu, and Daihong Liu
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Medicine ,Biology (General) ,QH301-705.5 - Abstract
Abstract Newly diagnosed patients with high-risk acute graft-versus-host disease (aGVHD) often experience poor clinical outcomes and low complete remission rates. Ruxolitinib with corticosteroids showed promising efficacy in improving response and failure free survival in our phase I study. This study (ClinicalTrials.gov: NCT04061876) sought to evaluate the safety and effectiveness of combining ruxolitinib (RUX, 5 mg/day) with corticosteroids (1 mg/kg/day methylprednisolone, RUX/steroids combined group) versus using methylprednisolone alone (2 mg/kg/day, steroids-only group). Newly diagnosed patients with intermediate- or high-risk aGVHD were included, with risk levels classified by either the Minnesota aGVHD Risk Score or biomarker assessment. Patients were randomized in a ratio of 1:1 into 2 groups: 99 patients received RUX combined with methylprednisolone, while the other 99 received methylprednisolone alone as the initial treatment. The RUX/steroids group showed a significantly higher overall response rate (ORR) on day 28 (92.9%) compared to the steroids-only group (70.7%, Odds Ratio [OR] = 5.8; 95% Confidence Interval [CI], 2.4–14.0; P
- Published
- 2024
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