Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis.
Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis.
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DOI：
10.1136/annrheumdis-2016-210724
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发表时间：
2017-09
影响因子：
27.4
通讯作者：
Gladman DD
中科院分区：
文献类型：
--
作者：
Mease PJ;Gottlieb AB;van der Heijde D;FitzGerald O;Johnsen A;Nys M;Banerjee S;Gladman DD
评估阿巴西普（一种选择性T细胞共刺激调节剂）在银屑病关节炎（PsA）III期研究中的疗效和安全性。这项研究将患有活动性PsA的患者（约60%先前暴露于肿瘤坏死因子抑制剂）（1：1）随机分配至每周皮下注射阿巴西普125 mg（n=213）或安慰剂（n=211），持续24周，然后是开放标签皮下注射阿巴西普。第16周关节计数改善不≥20%的患者转为开放标签阿巴西普治疗。主要终点为第24周时美国流变学会（ACR 20）标准改善≥20%的患者比例。在第24周，阿巴西普相对于安慰剂显著增加了ACR 20应答（39.4% vs 22.3%; p<0.001）。尽管阿巴西普在第24周在数字上增加了健康评估的焦虑-残疾指数反应率（从基线降低≥0.35），但这并不具有统计学显著性（31.0% vs 23.7%; p=0.097）。无论肿瘤坏死因子抑制剂暴露如何，阿巴西普的益处均见于ACR 20反应和其他肌肉骨骼表现，但由于在分级测试中排名低于健康评估量表-残疾指数反应，因此无法归因于显著性。然而，对银屑病病变的获益不大。疗效维持或改善至第52周。阿巴西普耐受性良好，无新的安全性信号。在这项III期研究中，阿巴西普治疗PsA达到了其主要终点，ACR 20反应，在肌肉骨骼表现方面总体上显示出有益的趋势，并且耐受性良好。对银屑病病变仅有适度影响。ClinicalTrials.gov编号，NCT 01860976（由百时美施贵宝公司资助）。
To assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA). This study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks, followed by open-label subcutaneous abatacept. Patients without ≥20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with ≥20% improvement in the American College of Rheumatology (ACR20) criteria at week 24. Abatacept significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; p<0.001). Although abatacept numerically increased Health Assessment Questionnaire–Disability Index response rates (reduction from baseline ≥0.35) at week 24, this was not statistically significant (31.0% vs 23.7%; p=0.097). The benefits of abatacept were seen in ACR20 responses regardless of tumour necrosis factor inhibitor exposure and in other musculoskeletal manifestations, but significance could not be attributed due to ranking below Health Assessment Questionnaire–Disability Index response in hierarchical testing. However, the benefit on psoriasis lesions was modest. Efficacy was maintained or improved up to week 52. Abatacept was well tolerated with no new safety signals. Abatacept treatment of PsA in this phase III study achieved its primary end point, ACR20 response, showed beneficial trends overall in musculoskeletal manifestations and was well tolerated. There was only a modest impact on psoriasis lesions. ClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb).
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影响因子：
--
作者：
Lebwohl, M;Christophers, E;Griffiths, CEM
通讯作者：
Griffiths, CEM
影响因子：
168.9
作者：
McInnes, Iain B.;Mease, Philip J.;Mpofu, Shephard
通讯作者：
Mpofu, Shephard
银屑病关节炎和牛皮癣中的Th17和Th22细胞。
影响因子：
4.9
作者：
Benham H;Norris P;Goodall J;Wechalekar MD;FitzGerald O;Szentpetery A;Smith M;Thomas R;Gaston H
通讯作者：
Gaston H
影响因子：
158.5
作者：
Genovese, MC;Becker, J;Dougados, M
通讯作者：
Dougados, M
影响因子：
--
作者：
Genovese, M. C.;Covarrubias, A.;Alten, R.
通讯作者：
Alten, R.