復宏漢霖-B(02696.HK)：3期臨試結果顯示，HLX03與原研阿達木單抗的療效相當、安全性和免疫原性特徵相似
格隆匯 10 月 29日丨復宏漢霖-B(02696.HK)宣佈，今日，公司自主開發的HLX03(阿達木單抗注射液)("HLX03")的3期臨牀研究數據以電子海報形式於2020年第二十九屆歐洲皮膚病與性病學會年會("EADV")大會線上平台發佈。
一項比較生物類似藥HLX03與阿達木單抗在中國中重度斑塊狀銀屑病患者中的療效、安全性和免疫原性的隨機、雙盲的3期等效臨牀試驗
(A)試驗設計
HLX03-Ps03是一項多中心、隨機、雙盲、平行對照的3期臨牀試驗(臨牀試驗號：NCT03316781)，旨在比較HLX03與原研阿達木單抗在中國中重度斑塊狀銀屑病患者中的療效、安全性和免疫原性差異。納入的患者按照1:1的比例隨機分為兩組，通過皮下注射HLX03或原研阿達木單抗進行給藥。第1周第1天藥物初始劑量為80mg，第2周第1天藥物劑量調整為40mg，此後直至第48周，藥物劑量為每2週一次，每次40mg。本試驗的主要研究終點為第16周時銀屑病面積與嚴重程度指數(PASIwk16)相對於基線改善的百分比。
(B)試驗結果
1)有效性a)
主要終點
本試驗入組了262例病患(HLX03組，n=132；原研組，n=130)。在全分析集(FAS)中，HLX03組和原研組PASIwk16相對於基線改善的百分比分別為83.48%和82.02%。兩組的最小二乘均差為1.46%(95%置信區間：-3.86%，6.79%)，落於預先設定的等效界值(±15%)範圍之內，證明HLX03和原研阿達木單抗的療效相似。
b)次要終點
試驗結果顯示，兩治療組的次要終點(包括PASI相對於基線至少改善75%的患者比例、PASI相對於基線改善的百分比、醫生整體評價(PGA)達到清除或幾乎清除的受試者比例、皮膚生活質量指數(DLQI)較基線變化)在第4、8、12、16、20、32、50周均無統計學差異。2)安全性及免疫原性HLX03和原研阿達木單抗的安全性和免疫原性特徵相似。
(C)結論
3期臨牀試驗結果顯示，HLX03與原研阿達木單抗的療效相當、安全性和免疫原性特徵相似。HLX03作為阿達木單抗生物類似藥候選藥有望為中重度斑塊狀銀屑病患者帶來更多治療選擇。
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