Clinical Development and Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma)., Ahmedabad, Gujarat, India.
Biostatistics and Programming, Lambda Therapeutic Research Ltd., Ahmedabad, Gujarat, India.
Indian J Pharmacol. 2021 Jan-Feb;53(1):6-12. doi: 10.4103/ijp.IJP_346_19.
The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of denosumab-biosimilar and denosumab-reference in postmenopausal osteoporotic women from India.
In this randomized, assessor-blind, active-control, multicenter trial, 114 patients were randomly allocated to receive denosumab-biosimilar (n = 58) or denosumab-reference (n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the primary end point.
Of 114 randomized patients, 111 (denosumab-biosimilar, n = 56; denosumab-reference, n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses, 110 (denosumab-biosimilar, n = 56; denosumab-reference, n = 54) were part of efficacy analysis, and 20 (denosumab-biosimilar, n = 10; denosumab-reference, n = 10) were part of PK analysis. The bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab-biosimilar and denosumab-reference (7.22 vs. 7.62; difference:-0.40; 95% confidence interval: -5.92, 5.12) showed no statistically relevant difference. Likewise, alkaline phosphatase (bone-specific) and PK parameters also did not show statistically relevant differences. Adverse events were reported in 44.83% of patients on denosumab-biosimilar versus 33.93% of patients on denosumab-reference; most events were mild or moderate and not related to the study drugs. No patients showed anti-denosumab antibody positivity.
Denosumab-biosimilar and denosumab-reference showed biosimilarity in osteoporotic postmenopausal women. Availability of denosumab-biosimilar provides a treatment alternative for patients.
本研究评估了地舒单抗生物类似药和地舒单抗参照药在印度绝经后骨质疏松女性中的疗效、安全性、药代动力学（PK）和免疫原性。
在这项随机、评估者盲法、活性对照、多中心试验中，114 名患者被随机分配接受地舒单抗生物类似药（n = 58）或地舒单抗参照药（n = 56），皮下剂量为每 6 个月 60mg，持续 1 年。每日给予维生素 D 和口服钙剂。腰椎骨密度（BMD）变化是主要终点。
在 114 名随机患者中，111 名（地舒单抗生物类似药，n = 56；地舒单抗参照药，n = 55）完成了研究。所有 114 名患者均纳入安全性和免疫原性分析，110 名（地舒单抗生物类似药，n = 56；地舒单抗参照药，n = 54）纳入疗效分析，20 名（地舒单抗生物类似药，n = 10；地舒单抗参照药，n = 10）纳入 PK 分析。地舒单抗生物类似药和地舒单抗参照药治疗 1 年后的骨密度（腰椎）百分比变化分别为 7.22%和 7.62%（差值：-0.40%；95%置信区间：-5.92，5.12），无统计学显著差异。同样，碱性磷酸酶（骨特异性）和 PK 参数也无统计学显著差异。地舒单抗生物类似药组有 44.83%的患者出现不良事件，地舒单抗参照药组有 33.93%的患者出现不良事件；大多数事件为轻度或中度，与研究药物无关。没有患者出现抗地舒单抗抗体阳性。
地舒单抗生物类似药和地舒单抗参照药在绝经后骨质疏松女性中表现出生物相似性。地舒单抗生物类似药的可及性为患者提供了一种治疗选择。
