CT-P42治疗糖尿病性黄斑水肿患者的长期疗效和安全性：一项3期随机临床试验的52周结果
Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial.
作者信息
Brown David M, Wolf Sebastian, Veselovsky Milan, Veith Miroslav, Papp Andras, Mange Shobhana, Mondal Lakshmi Kanta, Romanczak Dominika, Janco Ladislav, Chauhan Rohan, Romanowska-Dixon Bożena, Eremina Alena, Dusova Jaroslava, Sagong Min, Kim Sunghyun, Bae YunJu, Kim Suyoung, Bae Youngmin, Son Dain, Kang Hyejin, Choi Sujin, Stanga Paulo-Eduardo
机构信息
Retina Consultants of Texas, Retina Consultants of America, Houston, TX, USA.
Department of Ophthalmology, Inselspital, Bern University Hospital, Bern, Switzerland.
出版信息
Ophthalmol Ther. 2025 Aug 29. doi: 10.1007/s40123-025-01197-w.
INTRODUCTION
A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept in participants with diabetic macular edema. Here, we report long-term outcomes through week 52.
METHODS
This was a randomized, double-masked, active-controlled, phase 3 international trial, conducted at 83 study centers across Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine. Adults (aged ≥ 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period. Study data were collected from July 2021 to April 2023. Efficacy, safety, and immunogenicity of CT-P42 compared with reference aflibercept were evaluated until week 52.
RESULTS
Overall, 306 participants (CT-P42, 153; reference aflibercept, 153) completed the study through week 52. The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously. Improvements in best corrected visual acuity were maintained throughout and were similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively. Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52.
CONCLUSIONS
Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT04739306.
引言
先前一项为期24周的3期分析表明，候选生物类似药CT-P42与对照药阿柏西普在糖尿病性黄斑水肿患者中疗效相当，耐受性相当。在此，我们报告了至第52周的长期结果。
方法
这是一项随机、双盲、活性对照的3期国际试验，在捷克共和国、爱沙尼亚、德国、匈牙利、印度、拉脱维亚、立陶宛、波兰、韩国、俄罗斯、斯洛伐克、西班牙和乌克兰的83个研究中心进行。诊断为1型或2型糖尿病且糖尿病性黄斑水肿累及黄斑中心的成年人（年龄≥18岁）被随机分组（1:1），在为期52周的研究期间，每4周（共5剂）玻璃体内注射CT-P42或对照药阿柏西普（0.05 mL中含2 mg），之后每8周（共4剂）注射一次。研究数据收集于2021年7月至2023年4月。评估CT-P42与对照药阿柏西普相比直至第52周的疗效、安全性和免疫原性。
结果
总体而言，306名参与者（CT-P42组153名；对照药阿柏西普组153名）完成了至第52周的研究。先前已报告了至第8周最佳矫正视力自基线的平均变化这一主要疗效终点。整个研究期间最佳矫正视力均持续改善，CT-P42与对照药阿柏西普相似，在第52周时自基线的平均（标准差）变化分别为12.1（8.9）和11.1（9.9）个字母。至第52周，两组在中心子区域厚度及其他次要疗效终点以及安全性终点（包括治疗中出现的不良事件和免疫原性）方面自基线的变化相当。
结论
至第52周的结果表明CT-P42与对照药阿柏西普具有相当的长期疗效、安全性和免疫原性，支持二者的治疗等效性。
试验注册
ClinicalTrials.gov标识符：NCT04739306。
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