Article
作者: Zhang, Hong ; Cui, Ling ; Zhang, Wenfang ; Wang, Xian ; An, Liangbao ; Zhong, Jingxiang ; Peng, Jianjun ; Gao, Jianlu ; Chen, Changzheng ; Yang, Mochi ; Yuan, Songtao ; Wang, Linni ; Li, Mingxin ; Zhang, Qing ; Li, Zhuo ; Zhang, Tonghe ; Song, Zongming ; Tan, Liangzhang ; Song, Yanping ; You, Zhipeng ; Li, Xiaorong ; Hao, Jilong ; Zhang, Ming ; Xiong, Wei ; Jin, Yu ; Zhang, Jinglin ; Xu, Xinyan ; Peng, Xiaoyan ; Zhang, Ximei ; Zhou, Zixia ; Wang, Hailin ; Shen, Ye ; Tao, Liming ; Zhuang, Wenjuan ; Wang, Jianfeng ; Dai, Hong ; Ren, Xinjun ; Li, Zhiqing ; Wang, Hong ; Lou, Jing ; Liu, Xiaoling ; Liu, Yanli ; Tan, Wei ; Shi, Huijun ; Han, Quanhong ; Chen, Lixun ; Pan, Xuemei ; Zhao, Shuo ; Wu, Miaoqin ; Wang, Yanling ; Lu, Yingyi ; Li, Jun ; Lei, Chunling ; Ren, Qian
PURPOSE:To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar SSGJ-601 compared with ranibizumab in patients with macular edema secondary to branch retinal vein occlusion (BRVO).
DESIGN:A multicenter, randomized, double-masked, active-controlled phase III clinical study.
PARTICIPANTS:A total of 351 patients with macular edema secondary to BRVO were enrolled.
METHODS:Evaluable patients (N = 351) were randomized to receive intravitreal SSGJ-601 (1.25 mg per eye, every 4 weeks) or intravitreal ranibizumab (0.5 mg per eye, every 4 weeks) from day 1 through week 20 (6 injections in total), and treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria from weeks 24 to 48. All patients completed their end-of-study visit at week 52.
MAIN OUTCOME MEASURES:The primary efficacy end point was the least squares (LS) mean difference in change in best-corrected visual acuity (BCVA), measured by ETDRS letter score, from baseline to week 24. Secondary efficacy end points, safety, pharmacokinetics, immunogenicity, and changes in VEGF concentration of SSGJ-601 were also analyzed.
RESULTS:Demographic and baseline characteristics and exposure to treatment were similar between groups. In the study eye, SSGJ-601 was noninferior to ranibizumab in improving the LS mean in BCVA letter count from baseline to week 24 (17.6 [0.66] vs. 18.2 [0.65] letters, -0.6 with 95% confidence interval: -2.4 to 1.3, P for noninferiority <0.0001); thus, the primary clinical efficacy end point was met. At each time point, the proportions of patients achieving BCVA gains of ≥5, ≥10, and ≥15 letters in the SSGJ-601 group were noninferior to those in the ranibizumab group. Drug-related treatment-emergent adverse events (11.4% vs. 12.5%) and serious adverse events (6.9% vs. 9.1%) were comparable in the 2 treatment groups. A low incidence of binding antidrug antibodies was observed in the SSGJ-601 group.
CONCLUSIONS:This study supports the conclusion of no clinically meaningful differences in efficacy, safety, and immunogenicity between SSGJ-601 and ranibizumab in patients with macular edema secondary to BRVO. Additionally, treatment transitioned to a PRN schedule based on investigator-assessed retreatment criteria resulted in sustained benefits in visual and anatomical outcomes.
FINANCIAL DISCLOSURE(S):The authors have no proprietary or commercial interest in any materials discussed in this article.