School of Health Science, Faculty of Medicine, Tottori University, 86 Nishicho, Yonago City, Tottori, 683-8503, Japan.
Mochida Pharmaceutical Co. Ltd, Tokyo, Japan.
Osteoporos Int. 2019 Oct;30(10):2027-2037. doi: 10.1007/s00198-019-05038-y. Epub 2019 Jun 26.
The efficacy and safety of RGB-10 and reference teriparatide were evaluated in a randomized 52-week study in 250 patients with osteoporosis at high risk of fracture. RGB-10 was equivalent to reference teriparatide in efficacy and had a comparable safety profile.
RGB-10 is the first biosimilar teriparatide authorized in the European Union. This multicenter, randomized, rater-blinded, parallel-group phase 3 study evaluated equivalence in efficacy and compared safety between RGB-10 and reference teriparatide in patients with osteoporosis at high risk of fracture for registration in Japan.
Ambulatory postmenopausal women and men (≥ 55 years of age) with osteoporosis at high risk of fracture were randomized 1:1 to receive either RGB-10 or reference teriparatide 20 μg once daily via subcutaneous self-injection for 52 weeks. The primary efficacy endpoint was the percent change from baseline to 52 weeks in lumbar spine (L2-L4) bone mineral density (BMD). Safety outcomes and immunogenicity were also assessed.
In total, 250 patients (125 in each group) were randomized. The percent change from baseline to 52 weeks in lumbar spine (L2-L4) BMD (mean ± standard deviation) was 8.94% ± 6.19% in the RGB-10 group and 9.65% ± 6.22% in the reference teriparatide group. The estimated between-group difference (95% confidence interval) was - 0.65% (- 2.17% to - 0.87%) within the pre-specified equivalence margin (± 2.8%), which indicates equivalence in efficacy between the two groups. Changes in BMD at lumbar spine (L1-L4), femoral neck, and total hip and serum procollagen type I amino-terminal propeptide were also similar between the groups. Safety profiles, including immunogenicity, were comparable.
The therapeutic equivalence of RGB-10 to reference teriparatide was demonstrated. RGB-10 had comparable safety profile to that of reference teriparatide.
在一项纳入 250 例骨质疏松骨折高危患者的随机、52 周、双盲、平行分组的研究中，评估了 RGB-10 和参照特立帕肽的疗效和安全性。RGB-10 在疗效方面与参照特立帕肽相当，且具有相似的安全性。
RGB-10 是首个在欧盟获得批准的生物类似特立帕肽。这项多中心、随机、盲法、平行分组的 3 期研究评估了 RGB-10 与参照特立帕肽在日本注册的骨折高危骨质疏松患者中的疗效等效性，并比较了两者的安全性。
符合条件的患者为门诊绝经后女性和男性（年龄≥55 岁），患有骨折高危骨质疏松症，按 1:1 随机接受每日一次皮下自我注射 RGB-10 或参照特立帕肽 20μg，持续 52 周。主要疗效终点为基线至 52 周时腰椎（L2-L4）骨密度（BMD）的变化百分比。还评估了安全性结局和免疫原性。
共有 250 例患者（每组 125 例）被随机分组。RGB-10 组腰椎（L2-L4）BMD 的基线至 52 周的变化百分比为 8.94%±6.19%，参照特立帕肽组为 9.65%±6.22%。组间估计差值（95%置信区间）在预设的等效边界（±2.8%）内为-0.65%（-2.17%至-0.87%），表明两组之间的疗效等效。两组腰椎（L1-L4）、股骨颈和全髋关节 BMD 以及血清Ⅰ型前胶原氨基端前肽的变化也相似。安全性概况，包括免疫原性，也相当。
证明了 RGB-10 与参照特立帕肽的治疗等效性。RGB-10 与参照特立帕肽具有相似的安全性。
