Anti-NGF therapy improves osteoarthritis pain.
Anti-NGF therapy improves osteoarthritis pain.
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DOI：
10.1038/s41584-019-0266-y
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发表时间：
2019-08-01
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影响因子：
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通讯作者：
Collison, Joanna
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作者：
Collison, Joanna
生物仿制药RGB-10在一项针对日本骨质疏松症高危骨折患者的III期头对头研究中具有与参考特立帕肽相似的安全性和有效性。250例患者按1:1的比例随机分配，连续52周每天皮下注射20 μg RGB-10或20 μg特立帕肽。从基线到第52周，两个治疗组腰椎骨密度的变化是相同的，在不良事件方面没有重大差异。RGB-10目前在欧盟被批准用于与特立帕肽相同的适应症。Hagino， H.等。一项多中心、随机、非盲、平行组、3期研究，比较生物仿制药RGB-10和参比制剂特立帕肽在骨质疏松症患者中的疗效、安全性和免疫原性。Osteoporos。Int。https://doi。org/10.1007/s00198 y - 019 - 05038 - (2019)
The biosimilar RGB-10 had a similar safety and efficacy profile to reference teriparatide in a phase III head-to-head study in a Japanese cohort of patients with osteoporosis at high risk of fracture. 250 patients were randomly allocated on a 1: 1 basis to receive daily subcutaneous injections of either 20 μg RGB-10 or 20 μg teriparatide for 52 weeks. The change in lumbar spine bone mineral density from baseline to week 52 was equivalent between the two treatment groups and no major differences in adverse events were reported. RGB-10 is currently approved for use in the same indications as teriparatide in the EU.ORIgInAl ARTIclE Hagino, H. et al. A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis. Osteoporos. Int. https://doi. org/10.1007/s00198-019-05038-y (2019)