{"title":"生物仿制药阿达木单抗注射液与创新阿达木单抗治疗活动性强直性脊柱炎的疗效和安全性比较。","authors":"S Chandrashekara, Jyoti Ranjan Parida, Archana Sonawale, Vishnu Sharma, Kaushik Basu, John Mathew, Chethana Dharmapalaiah, Gaurav Seth, Girish Kakade, Neeraj Jain, Reena Sharma, Firdaus Fatima, Rajeshwar Nath Srivastava, Romi Shah, Bankim Desai, Ajit Nalawade, Vikram Haridas, Uma Kumar, A Ramakrishnam Naidu, Roshan Pawar, Amol Aiwale, Yogesh Rane, Vinayaka Shahavi, Akhilesh Sharma, Dattatreya Pawar","doi":"10.59556/japi.73.1117","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. (biosimilar) with innovator adalimumab (iADA) in subjects with active ankylosing spondylitis (AS).</p><p><strong>Methods: </strong>The prospective, multicenter, randomized, double-blind, phase 3 study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e., 125 subjects in the biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects were randomly assigned to receive either the biosimilar or iADA at a dose of 40 mg subcutaneously every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS and BASDAI response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, electrocardiogram (ECG), anti-adalimumab antibody (ADA) assessment, and laboratory tests.</p><p><strong>Results: </strong>A total of 192 patients were randomized into two groups: biosimilar adalimumab (<i>n</i> = 125) and iADA (<i>n</i> = 67). Baseline demographics, including mean age (32.6 vs 32.4 years) and BMI (23.5 vs 23.2 kg/m<sup>1</sup>), were comparable between groups. At 12 weeks, ASAS 20/40/70 responses were achieved by 97.5, 94.1, and 68.9% in the biosimilar group and by 98.4, 96.7, and 77% in the iADA group. A total of 44 AEs were reported in 27 subjects (14.1%), with an AE rate of 0.264 per person in the biosimilar arm and 0.16 in the iADA arm. ADA positivity rates were statistically nonsignificant between groups (<i>p</i> = 0.3516). Pharmacokinetic analysis confirmed bioequivalence with comparable Cmax and AUC values.</p><p><strong>Conclusion: </strong>The ASAS 20/40/70 response rates indicated the response to biosimilar at week 12 was similar to iADA. Both drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry-India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration number: CTRI/2020/09/028070.</p>","PeriodicalId":22693,"journal":{"name":"The Journal of the Association of Physicians of India","volume":"73 9","pages":"e21-e27"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparison of the Efficacy and Safety of Biosimilar Adalimumab Injection with Innovator Adalimumab in Subjects with Active Ankylosing Spondylitis.\",\"authors\":\"S Chandrashekara, Jyoti Ranjan Parida, Archana Sonawale, Vishnu Sharma, Kaushik Basu, John Mathew, Chethana Dharmapalaiah, Gaurav Seth, Girish Kakade, Neeraj Jain, Reena Sharma, Firdaus Fatima, Rajeshwar Nath Srivastava, Romi Shah, Bankim Desai, Ajit Nalawade, Vikram Haridas, Uma Kumar, A Ramakrishnam Naidu, Roshan Pawar, Amol Aiwale, Yogesh Rane, Vinayaka Shahavi, Akhilesh Sharma, Dattatreya Pawar\",\"doi\":\"10.59556/japi.73.1117\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. (biosimilar) with innovator adalimumab (iADA) in subjects with active ankylosing spondylitis (AS).</p><p><strong>Methods: </strong>The prospective, multicenter, randomized, double-blind, phase 3 study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e., 125 subjects in the biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects were randomly assigned to receive either the biosimilar or iADA at a dose of 40 mg subcutaneously every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS and BASDAI response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, electrocardiogram (ECG), anti-adalimumab antibody (ADA) assessment, and laboratory tests.</p><p><strong>Results: </strong>A total of 192 patients were randomized into two groups: biosimilar adalimumab (<i>n</i> = 125) and iADA (<i>n</i> = 67). Baseline demographics, including mean age (32.6 vs 32.4 years) and BMI (23.5 vs 23.2 kg/m<sup>1</sup>), were comparable between groups. At 12 weeks, ASAS 20/40/70 responses were achieved by 97.5, 94.1, and 68.9% in the biosimilar group and by 98.4, 96.7, and 77% in the iADA group. A total of 44 AEs were reported in 27 subjects (14.1%), with an AE rate of 0.264 per person in the biosimilar arm and 0.16 in the iADA arm. ADA positivity rates were statistically nonsignificant between groups (<i>p</i> = 0.3516). Pharmacokinetic analysis confirmed bioequivalence with comparable Cmax and AUC values.</p><p><strong>Conclusion: </strong>The ASAS 20/40/70 response rates indicated the response to biosimilar at week 12 was similar to iADA. Both drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry-India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration number: CTRI/2020/09/028070.</p>\",\"PeriodicalId\":22693,\"journal\":{\"name\":\"The Journal of the Association of Physicians of India\",\"volume\":\"73 9\",\"pages\":\"e21-e27\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Journal of the Association of Physicians of India\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.59556/japi.73.1117\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of the Association of Physicians of India","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.59556/japi.73.1117","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
目的：比较Enzene Biosciences Ltd.生产的阿达木单抗生物仿制药（biosimilar）与创新药物阿达木单抗（iADA）在活动性强直性脊柱炎（AS）患者中的疗效和安全性。方法：这项前瞻性、多中心、随机、双盲、3期研究包括在印度20个中心招募的192名活动性AS患者。符合资格标准的受试者按2:1的比例随机分配（即125名受试者在阿达木单抗生物仿制药组，67名受试者在iADA组）。选定的受试者被随机分配接受生物仿制药或iADA，每隔一周皮下注射40毫克，共12周。根据ASAS和BASDAI反应标准进行疗效评价。安全性评估基于完整的体格检查、不良事件（AE）监测、生命体征、心电图（ECG）、抗阿达木单抗（ADA）评估和实验室检查。结果：192例患者随机分为两组：生物仿制药阿达木单抗（n = 125）和iADA （n = 67）。基线人口统计数据，包括平均年龄（32.6 vs 32.4岁）和BMI (23.5 vs 23.2 kg/m1)，组间具有可比性。12周时，生物仿制药组的asa 20/40/70应答率分别为97.5、94.1和68.9%，iADA组为98.4、96.7和77%。27例受试者共报告44例AE(14.1%)，其中生物仿制药组的AE发生率为每人0.264例，iADA组的AE发生率为每人0.16例。ADA阳性率组间差异无统计学意义（p = 0.3516）。药代动力学分析证实生物等效性，Cmax和AUC值相当。结论：asa 20/40/70反应率表明，第12周生物仿制药的反应与iADA相似。两种药物具有相当的安全性和耐受性。试验注册名称：印度临床试验注册中心（CTRI），网址：http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene试验注册号：CTRI/2020/09/028070。
Comparison of the Efficacy and Safety of Biosimilar Adalimumab Injection with Innovator Adalimumab in Subjects with Active Ankylosing Spondylitis.
Objectives: To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. (biosimilar) with innovator adalimumab (iADA) in subjects with active ankylosing spondylitis (AS).
Methods: The prospective, multicenter, randomized, double-blind, phase 3 study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e., 125 subjects in the biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects were randomly assigned to receive either the biosimilar or iADA at a dose of 40 mg subcutaneously every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS and BASDAI response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, electrocardiogram (ECG), anti-adalimumab antibody (ADA) assessment, and laboratory tests.
Results: A total of 192 patients were randomized into two groups: biosimilar adalimumab (n = 125) and iADA (n = 67). Baseline demographics, including mean age (32.6 vs 32.4 years) and BMI (23.5 vs 23.2 kg/m1), were comparable between groups. At 12 weeks, ASAS 20/40/70 responses were achieved by 97.5, 94.1, and 68.9% in the biosimilar group and by 98.4, 96.7, and 77% in the iADA group. A total of 44 AEs were reported in 27 subjects (14.1%), with an AE rate of 0.264 per person in the biosimilar arm and 0.16 in the iADA arm. ADA positivity rates were statistically nonsignificant between groups (p = 0.3516). Pharmacokinetic analysis confirmed bioequivalence with comparable Cmax and AUC values.
Conclusion: The ASAS 20/40/70 response rates indicated the response to biosimilar at week 12 was similar to iADA. Both drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry-India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration number: CTRI/2020/09/028070.
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