Comparison of recombinant human FSH biosimilar QL1012 with Gonal- f ((R)) for ovarian stimulation: a phase-three trial

作者全名："Hu, Linli; Lv, Jieqiang; Ma, Qianhong; Chen, Xiujuan; Wang, Xiaohong; Liang, Xiaoyan; Xu, Dingfei; Li, Yanping; Huang, Yuanhua; Hu, Lina; Deng, Xiaohui; Wei, Jing; Zhou, Feng; Zhang, Songying; Wang, Jie; Ma, Fang; Sun, Yingpu"

作者地址："[Hu, Linli; Sun, Yingpu] Zhengzhou Univ, Reprod Med Ctr, Affiliated Hosp 1, Zhengzhou, Peoples R China; [Lv, Jieqiang] Wenzhou Med Univ, Reprod Med Ctr, Affiliated 2, Wenzhou, Peoples R China; [Ma, Qianhong] Sichuan Univ, Reprod Med Ctr, West China Univ Hosp 2, Chengdu, Peoples R China; [Chen, Xiujuan] Inner Mongolia Med Univ, Reprod Med Ctr, Affiliated Hosp, Hohhot, Peoples R China; [Wang, Xiaohong] Tangdu Hosp, Reprod Med Ctr, Xian, Peoples R China; [Liang, Xiaoyan] Sun Yat Sen Univ, Affiliated Hosp 6, Reprod Med Ctr, Guangzhou, Peoples R China; [Xu, Dingfei] Jiangxi Maternal & Child Hlth Hosp, Reprod Med Ctr, Nanchang, Peoples R China; [Li, Yanping] Cent South Univ, Reprod Med Ctr, Xiangya Hosp, Changsha, Peoples R China; [Huang, Yuanhua] Hainan Med Coll, Reprod Med Ctr, Affiliated Hosp 1, Haikou, Peoples R China; [Hu, Lina] Chongqing Med Univ Chongqing, Reprod Med Ctr, Affiliated Hosp 2, Chongqing, Peoples R China; [Deng, Xiaohui] Shandong Univ, Reprod Med Ctr, Qilu Hosp, Jinan, Peoples R China; [Wei, Jing] Liuzhou Workers Hosp, Reprod Med Ctr, Liuzhou, Peoples R China; [Zhou, Feng; Zhang, Songying] Zhejiang Univ, Dept Obstet & Gynecol, Assisted Reprod Unit, Sir Run Run Shaw Hosp,Sch Med, Hangzhou, Peoples R China; [Wang, Jie; Ma, Fang] Qilu Pharmaceut Co Ltd, Clin Res Ctr, Jinan, Peoples R China"

通信作者："Sun, YP (通讯作者)，Zhengzhou Univ, Reprod Med Ctr, Affiliated Hosp 1, Zhengzhou, Peoples R China."

来源：REPRODUCTIVE BIOMEDICINE ONLINE

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000980762900001

JCR分区：Q1

影响因子：3.7

年份：2023

卷号：46

期号：3

开始页：511

结束页：518

文献类型：Article

关键词：Assisted reproductive technology; Biosimilar; Gonal-f; QL1012; Recombinant human follicle-stimulating hormone

摘要："Research question: Are QL1012 and Gonal-f ((R)) equivalent in women undergoing ovarian stimulation for assisted reproductive technology (ART)? Design: This multicentre, randomized, assessor-blinded, phase-three trial was conducted at 13 centres in China. Eligible patients were infertile women; age 20-39 years; body mass index 18-30 kg/m(2); regular menstrual cycles; and indication for ART. After successful pituitary downregulation, patients were randomly assigned (1:1) to receive QL1012 or Gonal-f((R)), stratified by age (initial dose of 75-150 IU for women younger than 30 years, 150-225 IU for women aged 30-34 years and 225-300 IU for women aged >= 35 years, subcutaneously, once daily). The primary end point was the number of oocytes retrieved. Results: Between October 2018, and June 2019, 341 patients were included in the per-protocol set. The mean numbers of oocytes retrieved were 14.7 +/- 7.0 in the QL1012 group (n = 169) and 13.4 +/- 6.1 in the Gonal-f((R)) group (n = 172). Adjusted by analysis of covariance model, the least-squares mean difference was 1.3 oocytes (95% CI -0.1 to 2.7; P = 0.0650), within the predefined equivalence margins of +/- 3.0. Similar results were observed in the full analysis set. Additionally, no statistical differences were found in secondary end points except oestradiol concentration (median 3948.0 pg/ml versus 3545.3 pg/ml; P = 0.0015). Ovarian hyperstimulation syndrome (12.4% versus 13.1 %) and other adverse events were similar between the two groups. Conclusions: Therapeutic equivalence and similar safety profiles were demonstrated between QL1012 and Gonal-f((R)) in women undergoing ovarian stimulation for ART."

基金机构："Qilu Pharmaceutical Co., Ltd."

基金资助正文："This work was supported by Qilu Pharmaceutical Co., Ltd."