复宏汉霖(02696.HK)于中华医学会第二十五次全国风湿病学学术会议首次发布HLX01用于类风湿关节炎治疗的3期临床试验数据
格隆汇5月20日丨复宏汉霖(02696.HK)宣布，今日，公司自主开发的HLX01(利妥昔单抗注射液)("HLX01")用于类风湿关节炎(Rheumatoid Arthritis, RA)治疗的3期临床试验(HLX01-RA03, NCT03522415)数据以摘要及壁报形式于中华医学会第二十五次全国风湿病学学术会议发布，这也是公司首次公布HLX01用于类风湿关节炎(RA)治疗的3期临床试验数据，该等临床试验数据亦将于近日于2021年欧洲风湿病学大会("EULAR 2021")线上平台发布。
B. 入选试验详情
摘要及壁报标题：一项在甲氨蝶呤治疗应答不完全的中重度活动性类风湿关节炎受试者中评估HLX01治疗的有效性和安全性的随机、双盲、安慰剂对照的3期临床试验
展示形式：摘要及壁报
试验设计：HLX01-RA03是一项在甲氨蝶呤治疗应答不完全(MTX-IR)的中重度活动性类风湿关节炎(RA)患者中评估HLX01联合甲氨蝶呤(MTX)治疗的有效性和安全性的随机、双盲、安慰剂对照的3期临床研究。纳入的患者按2:1随机分为两组，分别在第1天和第15天静脉输注1,000mg HLX01或安慰剂。在第169天(第24周第1天)和第183天，HLX01组和安慰剂组受试者均静脉输注1,000mg HLX01。同时，所有受试者均接收稳定剂量的甲氨蝶呤(MTX)。第16周和20周时如患者对已接受治疗无应答，则开始进行挽救治疗。该研究的主要终点为第24周达到美国风湿病学会20%缓解标准(ACR20)的患者比例。
试验结果：
1) 有效性
a) 主要终点：本试验共入组275名患者(HLX01组，n = 183; 安慰剂组，n = 92)。24周时，意向分析集(ITT)人群中HLX01组达到ACR20的患者比例相较於安慰剂组有显着的提升(60.7% vs 35.9%; odds ratio [OR],2.756 [95% CI 1.640, 4.632]; P < 0.001)。
b) 次要终点：次要疗效终点包含达到ACR20/50/70反应标准的患者比例、基于C反应蛋白(CRP)及基於血沉(ESR)的28关节疾病活动度评分(DAS28)、基于健康评估问卷残疾指数(HAQ-DI)评估躯体功能的改善等。试验结果显示，HLX01各次要疗效终点较安慰剂也有显著的提升。
2) 安全性
HLX01组和安慰剂组治疗后不良事件(TEAE)、药物不良反应(ADR)及导致研究药物停用的TEAE的发生率均相似。
结论：
HLX01联合甲氨蝶呤相较于安慰剂，在甲氨蝶呤治疗应答不完全(MTX-IR)的中国中重度活动性类风湿关节炎(RA)受试者中具有显著的临床疗效和良好的安全性，证明HLX01联合MTX是一种可耐受、安全、有效的治疗选择。
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