Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis
Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis
复制标题
年龄对培菲替尼（ASP015K）治疗类风湿关节炎疗效和安全性的影响
DOI：
10.1093/mr/roab058
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发表时间：
2022
影响因子：
2.2
通讯作者：
Miyatake Daisuke
中科院分区：
文献类型：
--
作者：
Tanaka Yoshiya;Takeuchi Tsutomu;Kato Daisuke;Kaneko Yuichiro;Fukuda Musashi;Miyatake Daisuke
ObjectivesTo evaluate peficitinib efficacy and safety in Asian patients with rheumatoid arthritis（RA），layered by age（≥20-<50，≥50-<65，and ≥65 years）.汇总了1项II期、2项III期和1项开放标签扩展研究的安全性数据。计算每100患者-年特别关注的不良事件发生率，并进行考克斯比例风险分析。结果1052例患者接受培非西替尼治疗2年（中位数）。在所有年龄组中，与安慰剂相比，Peficitinib均显示出疗效改善。发生率≥20-<50岁、≥50-<65岁和≥65岁的每100患者-年（95%置信区间）为0.8严重感染分别为2.6（1.8，3.7）和4.7（3.1，7.0），带状疱疹相关疾病分别为3.7（2.5，5.4）、6.4（5.0，8.2）和11.2（8.5，14.7）。在汇总的II/III期研究中，20例患者报告了恶性肿瘤。严重感染和带状疱疹相关疾病的发病率随年龄的增长显着增加，但没有与基线估计肾小球滤过率。年龄，而不是估计的肾小球滤过率，与严重感染和带状疱疹相关疾病，证明了适当的RA治疗策略在老年患者的重要性。
ObjectivesTo evaluate peficitinib efficacy and safety in Asian patients with rheumatoid arthritis (RA), stratified by age (≥20–<50, ≥50–<65, and ≥65 years).MethodsEfficacy data from two Phase 3 studies were analysed. Safety data from one Phase 2, two Phase 3, and one open-label extension study were pooled. Incidence rates per 100 patient-years of adverse events of special interest were calculated, and Cox proportional hazard analysis was conducted.Results1052 patients received peficitinib for 2 years (median). Peficitinib demonstrated efficacy improvements versus placebo across all age categories. Incidence rates (95% confidence interval) per 100 patient-years for ≥20–<50, ≥50–<65, and ≥65 years were 0.8 (0.4, 1.9), 2.6 (1.8, 3.7), and 4.7 (3.1, 7.0) for serious infections and 3.7 (2.5, 5.4), 6.4 (5.0, 8.2), and 11.2 (8.5, 14.7) for herpes zoster–related disease, respectively. Twenty patients reported malignancies in pooled Phase 2/3 studies. Incidences of serious infections and herpes zoster–related disease increased significantly with age, but there was no association with baseline estimated glomerular filtration rate.ConclusionsPeficitinib was efficacious in adult Asian RA patients of all ages. Age, but not estimated glomerular filtration rate, was associated with serious infections and herpes zoster–related disease, demonstrating the importance of an appropriate RA treatment strategy in older patients.