乌司奴单抗治疗伴外周关节炎和医生报告的脊柱炎的银屑病关节炎患者的疗效和安全性：两项 III 期、多中心、双盲、安慰剂对照研究（PSUMMIT-1/PSUMMIT-2）的事后分析。
Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2).
机构信息
Division of Rheumatology, Allergy, and Immunology, University of California-San Diego, La Jolla, California, USA.
Department of Dermatology, Hospital de la Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain.
出版信息
Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.
OBJECTIVE
To evaluate ustekinumab efficacy and safety in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (termed the 'spondylitis subset').
METHODS
Adults with active PsA (PSUMMIT-1/PSUMMIT-2, n=615/312) were randomised to ustekinumab 45 mg, 90 mg or placebo at week 0/week 4/q12 week. At week 16, patients with <5% improvement in tender and swollen joints entered blinded early escape. A subset of patients with physician-identified spondylitis was evaluated with spondylitis-specific assessments, including Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score employing C reactive protein (ASDAS-CRP), through week 24.
RESULTS
256/927 (27.6%) PSUMMIT-1/PSUMMIT-2 patients (placebo/ustekinumab, n=92/164) comprised the evaluable spondylitis subset. At week 24, in this analysis subset, significantly more patients achieved BASDAI20/50/70 responses (54.8%/29.3%/15.3% vs 32.9%/11.4%/0%; p≤0.002), improvement in BASDAI question 2 concerning axial pain (1.85 vs 0.24; p<0.001) and mean per cent ASDAS-CRP improvements (27.8% vs 3.9%; p<0.001) for ustekinumab versus placebo recipients, respectively. Comparable to the overall study population, significant improvements were also achieved in psoriasis, peripheral arthritis, enthesitis, dactylitis, physical function and peripheral joint radiographs in the spondylitis subset.
CONCLUSIONS
In this post-hoc analysis of PsA patients with baseline peripheral arthritis and physician-reported spondylitis, ustekinumab-treated patients demonstrated significant improvements in axial signs and symptoms through week 24.
TRIAL REGISTRATION NUMBER
PSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.
目的
评估乌司奴单抗在伴有外周关节炎和医生报告的脊柱炎（称为“脊柱炎亚组”）的银屑病关节炎（PsA）患者中的疗效和安全性。
方法
在 PSUMMIT-1/PSUMMIT-2 中，615 例成人活动性 PsA 患者随机接受乌司奴单抗 45mg、90mg 或安慰剂，分别在第 0 周/第 4 周和第 12 周进行治疗。在第 16 周，关节压痛和肿胀改善＜5%的患者进入盲态早期逃逸。通过第 24 周，评估了具有医生确定的脊柱炎的患者亚组，评估包括巴斯强直性脊柱炎疾病活动指数（BASDAI）和 C 反应蛋白（ASDAS-CRP）的强直性脊柱炎疾病活动评分。
结果
PSUMMIT-1/PSUMMIT-2 中有 256/927 例（安慰剂/乌司奴单抗，n=92/164）患者为可评估的脊柱炎亚组。在本分析亚组中，与安慰剂相比，在第 24 周时，更多的患者达到了 BASDAI20/50/70 反应（54.8%/29.3%/15.3% vs 32.9%/11.4%/0%；p≤0.002），与轴向疼痛相关的 BASDAI 问题 2 改善（1.85 与 0.24；p<0.001）和平均百分比 ASDAS-CRP 改善（27.8% 与 3.9%；p<0.001），乌司奴单抗治疗组优于安慰剂组。与总体研究人群相似，在脊柱炎亚组中，银屑病、外周关节炎、附着点炎、指（趾）炎、身体功能和外周关节 X 线也取得了显著改善。
结论
在这项伴有基线外周关节炎和医生报告的脊柱炎的 PsA 患者的事后分析中，乌司奴单抗治疗的患者在第 24 周时，轴性体征和症状得到了显著改善。
试验注册号
PSUMMIT-1（NCT01009086，EudraCT 2009-012264-14）和 PSUMMIT-2（NCT01077362，EudraCT 2009-012265-60）；研究后结果。
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