Mease Philip, Choy Ernest, Nash Peter, Kalyvas Chrysostomos, Hunger Matthias, Pricop Luminita, Gandhi Kunal K, Jugl Steffen M, Thom Howard
Swedish Medical Center and University of Washington, Seattle, WA, USA.
CREATE Centre, Section of Rheumatology, Cardiff University School of Medicine, Cardiff, UK.
Eur J Rheumatol. 2018 Jul 1;6(3):113-121. doi: 10.5152/eurjrheum.2019.19057. Print 2019 Jul.
Matching-adjusted indirect comparison (MAIC) can be used to assess the comparative effectiveness of two treatments indirectly using data from randomized placebo-controlled trials. This MAIC assessed the comparative effectiveness of secukinumab (an anti-interleukin-17A) and etanercept (a tumor necrosis factor inhibitor) in a target population of biologic-naïve patients with psoriatic arthritis (PsA).
Individual patient data pooled from FUTURE 2 (NCT01752634), FUTURE 3 (NCT01989468), and FUTURE 5 (NCT02404350) (secukinumab: 150 mg, n=458 and 300 mg, n=461) were matched to data from the population in the NCT00317499 trial (etanercept 25 mg, n=101) using MAIC methodology, by adjusting for clinical and demographic baseline characteristics. Recalculated outcomes from FUTURE 2, 3, and 5 (150 mg, effective sample size (ESS) post-matching=104; 300 mg, ESS=75; and placebo, ESS=159) were compared with the NCT00317499 trial. Pairwise comparisons using odds ratios (ORs) were performed for the American College of Rheumatology (ACR) 20, 50, and 70 response criteria at week 12 (placebo-adjusted) and week 24 (non-placebo-adjusted).
At week 12, there were no significant differences in ACR responses between secukinumab and etanercept. There was no significant difference between secukinumab 150 mg and etanercept at week 24 with respect to ACR 20 and 50 response rates; however, ACR 70 response rates were higher for secukinumab 150 mg (OR (95% confidence interval (CI)): 4.48 (2.01-9.99), p<0.001). ACR 20, 50, and 70 response rates were higher with secukinumab 300 mg than with etanercept at this time point (OR (95% CI): ACR 20, 3.28 (1.69-6.38), p<0.001; ACR 50, 1.90 (1.04-3.50), p=0.038; and ACR 70, 3.56 (1.51-8.40), p=0.004).
In this MAIC, secukinumab was associated with higher ACR 20 and 50 (secukinumab 300 mg) and 70 (secukinumab 150 mg and 300 mg) response rates at week 24 than etanercept in biologic-naïve patients with active PsA, whereas no significant difference was observed in the short-term at week 12.
匹配调整间接比较(MAIC)可用于利用随机安慰剂对照试验的数据间接评估两种治疗方法的相对疗效。本MAIC评估了司库奇尤单抗(一种抗白细胞介素-17A药物)和依那西普(一种肿瘤坏死因子抑制剂)在初治银屑病关节炎(PsA)患者目标人群中的相对疗效。
采用MAIC方法,通过调整临床和人口统计学基线特征,将来自FUTURE 2(NCT01752634)、FUTURE 3(NCT01989468)和FUTURE 5(NCT02404350)(司库奇尤单抗:150mg,n = 458;300mg,n = 461)的个体患者数据与NCT00317499试验人群(依那西普25mg,n = 101)的数据进行匹配。将FUTURE 2、3和5重新计算的结果(150mg,匹配后有效样本量(ESS)= 104;300mg,ESS = 75;安慰剂,ESS = 159)与NCT00317499试验进行比较。在第12周(安慰剂调整)和第24周(非安慰剂调整),针对美国风湿病学会(ACR)20、50和70反应标准,使用比值比(OR)进行成对比较。
在第12周,司库奇尤单抗和依那西普之间的ACR反应无显著差异。在第24周时:就ACR 20和50反应率而言,司库奇尤单抗150mg与依那西普之间无显著差异;然而,司库奇尤单抗150mg的ACR 70反应率更高(OR(95%置信区间(CI)):4.48(2.01 - 9.99),p < 0.001)。在该时间点,司库奇尤单抗300mg的ACR 20、50和70反应率高于依那西普(OR(95%CI):ACR 20,3.28(1.69 - 6.38),p < 0.001;ACR 50,1.90(1.04 - 3.50),p = 0.038;ACR 70,3.56(1.51 - 8.40),p = 0.004)。
在本MAIC中,对于初治的活动性PsA患者,在第24周时,司库奇尤单抗比依那西普具有更高的ACR 20和50(司库奇尤单抗300mg)以及70(司库奇尤单抗150mg和300mg)反应率,而在第12周的短期内未观察到显著差异。