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Efficacy and safety of adalimumab in Japanese patients with psoriatic arthritis and inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs): A prospective, observational study.

阿达木单抗治疗日本银屑病关节炎和对非甾体抗炎药 (NSAIDs) 反应不足患者的疗效和安全性: 一项前瞻性、观察性研究。

  • 影响因子:1.72
  • DOI:10.1080/14397595.2019.1589739
  • 作者列表:"Morita A","Okuyama R","Katoh N","Tateishi C","Masuda K","Komori T","Ogawa E","Makino T","Nishida E","Nishimoto S","Muramoto K","Tsuruta D","Ihn H
  • 发表时间:2020-01-01
Abstract

:Objectives: To evaluate the efficacy and safety of adalimumab in psoriatic arthritis (PsA) patients in Japan.Methods: In this open-label, single-arm study conducted at six sites from October 2014 to June 2016 (UMIN000016543), PsA patients (≥20 years old) with inadequate response to nonsteroidal anti-inflammatory drugs received adalimumab subcutaneously (80 mg initially, then 40 mg every other week; 24 weeks total). Primary endpoint was American College of Rheumatology 20% improvement (ACR20) response rate at week 12.Results: Of 42 enrolled patients, 37 were treated (mean (SD) age, 56.2 (13.0) years; male, 27 (73.0%)). ACR20, ACR50, and ACR70 response rates were 40.5%, 24.3%, and 16.2% at week 12 and increased to 45.9%, 37.8%, and 21.6% at week 24, respectively. Psoriasis Area and Severity Index (PASI) 50 response rates were unchanged at weeks 12 and 24 (73%), but PASI75 and PASI90 increased from 40.5% and 21.6% to 59.5% and 40.5%, respectively. Other indices such as Physician's Global Assessment score, C-reactive protein-based disease activity score in 28 joints, Bath Ankylosing Spondylitis Disease Activity Index, and serum biomarker levels were significantly improved. No unexpected adverse events were reported.Conclusion: Similar to the global population, adalimumab was efficacious and well tolerated in Japanese treatment-experienced PsA patients.

摘要

目的: 评价阿达木单抗治疗日本银屑病关节炎 (PsA) 患者的疗效和安全性。方法: 在 2014 年 10 月至 2016 年 6 月在 6 个地点进行的开放标签、单组研究中 (UMIN000016543),PsA患者 (≥ 20 岁) 由于对非甾体抗炎药的反应不足,接受阿达木单抗皮下注射(最初 80 mg,然后每隔一周 40 mg; 共 24 周)。主要终点是 12 周时美国风湿病学会 20% 改善 (ACR20) 应答率。结果: 42 例入组患者中,37 例接受治疗 (平均 (SD) 年龄,56.2 (13.0) 岁; 男性,27 (73.0%))。第 12 周时ACR20 、ACR50 和ACR70 应答率分别为 40.5% 、 24.3% 和 16.2%,第 24 周时分别增至 45.9% 、 37.8% 和 21.6%。银屑病面积和严重程度指数 (PASI) 50 反应率在 12 周和 24 周 (73%) 不变,但PASI75 和PASI90 分别从 40.5% 和 21.6% 增加到 59.5% 和 40.5%。其他指标如医生的整体评估评分、 28 个关节基于C反应蛋白的疾病活动评分、Bath强直性脊柱炎疾病活动指数、血清生物标志物水平等均显著改善。无意外不良事件报道。结论: 与全球人群相似,阿达木单抗在日本治疗经验的PsA患者中有效且耐受性良好。

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发表时间:2020-01-01
DOI:10.1002/acr.23824
作者列表:["Chen SK","Liao KP","Liu J","Kim SC"]

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发表时间:2020-01-01
DOI:10.1002/acr.23827
作者列表:["Lee RR","Rashid A","Thomson W","Cordingley L"]

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