復宏漢霖(02696.HK)於中華醫學會第二十五次全國風濕病學學術會議首次發佈HLX01用於類風濕關節炎治療的3期臨牀試驗數據
格隆匯5月20日丨復宏漢霖(02696.HK)宣佈，今日，公司自主開發的HLX01(利妥昔單抗注射液)("HLX01")用於類風濕關節炎(Rheumatoid Arthritis, RA)治療的3期臨牀試驗(HLX01-RA03, NCT03522415)數據以摘要及壁報形式於中華醫學會第二十五次全國風濕病學學術會議發佈，這也是公司首次公佈HLX01用於類風濕關節炎(RA)治療的3期臨牀試驗數據，該等臨牀試驗數據亦將於近日於2021年歐洲風濕病學大會("EULAR 2021")線上平台發佈。
B. 入選試驗詳情
摘要及壁報標題：一項在甲氨蝶呤治療應答不完全的中重度活動性類風濕關節炎受試者中評估HLX01治療的有效性和安全性的隨機、雙盲、安慰劑對照的3期臨牀試驗
展示形式：摘要及壁報
試驗設計：HLX01-RA03是一項在甲氨蝶呤治療應答不完全(MTX-IR)的中重度活動性類風濕關節炎(RA)患者中評估HLX01聯合甲氨蝶呤(MTX)治療的有效性和安全性的隨機、雙盲、安慰劑對照的3期臨牀研究。納入的患者按2:1隨機分為兩組，分別在第1天和第15天靜脈輸注1,000mg HLX01或安慰劑。在第169天(第24周第1天)和第183天，HLX01組和安慰劑組受試者均靜脈輸注1,000mg HLX01。同時，所有受試者均接收穩定劑量的甲氨蝶呤(MTX)。第16周和20周時如患者對已接受治療無應答，則開始進行挽救治療。該研究的主要終點為第24周達到美國風濕病學會20%緩解標準(ACR20)的患者比例。
試驗結果：
1) 有效性
a) 主要終點：本試驗共入組275名患者(HLX01組，n = 183; 安慰劑組，n = 92)。24周時，意向分析集(ITT)人羣中HLX01組達到ACR20的患者比例相較於安慰劑組有顯着的提升(60.7% vs 35.9%; odds ratio [OR],2.756 [95% CI 1.640, 4.632]; P < 0.001)。
b) 次要終點：次要療效終點包含達到ACR20/50/70反應標準的患者比例、基於C反應蛋白(CRP)及基於血沉(ESR)的28關節疾病活動度評分(DAS28)、基於健康評估問卷殘疾指數(HAQ-DI)評估軀體功能的改善等。試驗結果顯示，HLX01各次要療效終點較安慰劑也有顯著的提升。
2) 安全性
HLX01組和安慰劑組治療後不良事件(TEAE)、藥物不良反應(ADR)及導致研究藥物停用的TEAE的發生率均相似。
結論：
HLX01聯合甲氨蝶呤相較於安慰劑，在甲氨蝶呤治療應答不完全(MTX-IR)的中國中重度活動性類風濕關節炎(RA)受試者中具有顯著的臨牀療效和良好的安全性，證明HLX01聯合MTX是一種可耐受、安全、有效的治療選擇。
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