司库奇尤单抗与阿达木单抗治疗银屑病关节炎的疗效比较：使用匹配调整间接比较法评估至48周的疗效
Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison.
作者信息
Nash Peter, McInnes Iain B, Mease Philip J, Thom Howard, Hunger Matthias, Karabis Andreas, Gandhi Kunal, Mpofu Shephard, Jugl Steffen M
机构信息
University of Queensland, Brisbane, QLD, Australia.
University of Glasgow, Glasgow, UK.
出版信息
Rheumatol Ther. 2018 Jun;5(1):99-122. doi: 10.1007/s40744-018-0106-6. Epub 2018 Mar 31.
INTRODUCTION
Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations.
METHODS
Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs. placebo; N = 313). Logistic regression determined adjustment weights for age, body weight, sex, race, methotrexate use, psoriasis affecting ≥ 3% of body surface area, Psoriasis Area and Severity Index score, Health Assessment Questionnaire Disability Index score, presence of dactylitis and enthesitis, and previous anti-TNF therapy. Recalculated secukinumab outcomes were compared with adalimumab outcomes at weeks 12 (placebo-adjusted), 16, 24, and 48 (nonplacebo-adjusted).
RESULTS
After matching, the effective sample size for FUTURE 2 was 101. Week 12 American College of Rheumatology (ACR) response rates were not significantly different between secukinumab and adalimumab. Week 16 ACR 20 and 50 response rates were higher for secukinumab 150 mg than for adalimumab (P = 0.017, P = 0.033), as was ACR 50 for secukinumab 300 mg (P = 0.030). Week 24 ACR 20 and 50 were higher for secukinumab 150 mg than for adalimumab (P = 0.001, P = 0.019), as was ACR 20 for secukinumab 300 mg (P = 0.048). Week 48 ACR 20 was higher for secukinumab 150 and 300 mg than for adalimumab (P = 0.002, P = 0.027), as was ACR 50 for secukinumab 300 mg (P = 0.032).
CONCLUSIONS
In our analysis, patients with PsA receiving secukinumab were more likely to achieve higher ACR responses through 1 year (weeks 16-48) than those treated with adalimumab. Although informative, these observations rely on a subgroup of patients from FUTURE 2 and thus should be considered interim until the ongoing head-to-head RCT EXCEED can validate these findings.
FUNDING
Novartis Pharma AG.
引言
司库奇尤单抗和阿达木单抗已被批准用于治疗活动性银屑病关节炎（PsA）的成人患者。在缺乏直接随机对照试验（RCT）数据的情况下，匹配调整间接比较可估计在未使用过抗肿瘤坏死因子（TNF）药物的人群中的相对疗效。
方法
将来自FUTURE 2随机对照试验（司库奇尤单抗对比安慰剂；N = 299）的个体患者数据进行调整，以匹配ADEPT随机对照试验（阿达木单抗对比安慰剂；N = 313）的基线特征。逻辑回归确定了年龄、体重、性别、种族、甲氨蝶呤使用情况、银屑病累及体表面积≥3%、银屑病面积和严重程度指数评分、健康评估问卷残疾指数评分、指（趾）炎和附着点炎的存在情况以及既往抗TNF治疗的调整权重。在第12周（安慰剂调整后）、16周、24周和48周（非安慰剂调整后），将重新计算的司库奇尤单抗结果与阿达木单抗结果进行比较。
结果
匹配后，FUTURE 2的有效样本量为101。第12周时，司库奇尤单抗和阿达木单抗的美国风湿病学会（ACR）反应率无显著差异。第16周时，150mg司库奇尤单抗的ACR 20和50反应率高于阿达木单抗（P = 0.017，P = 0.033），300mg司库奇尤单抗的ACR 50反应率也高于阿达木单抗（P = 0.030）。第24周时，150mg司库奇尤单抗的ACR 20和50反应率高于阿达木单抗（P = 0.001，P = 0.019），300mg司库奇尤单抗的ACR 20反应率也高于阿达木单抗（P = 0.048）。第48周时，150mg和300mg司库奇尤单抗的ACR 20反应率高于阿达木单抗（P = 0.002，P = 0.027），300mg司库奇尤单抗的ACR 50反应率也高于阿达木单抗（P = 0.032）。
结论
在我们的分析中，与接受阿达木单抗治疗的患者相比，接受司库奇尤单抗治疗的PsA患者在1年（第16 - 48周）内更有可能获得更高的ACR反应。尽管这些观察结果具有参考价值，但这些观察依赖于FUTURE 2试验中的部分患者，因此在正在进行的头对头随机对照试验EXCEED验证这些发现之前，应将其视为中期结果。
资助
诺华制药公司。
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