Maksymowych Walter P, Strand Vibeke, Nash Peter, Yazici Yusuf, Thom Howard, Hunger Matthias, Kalyvas Chrysostomos, Gandhi Kunal K, Porter Brian, Jugl Steffen M
Division of Rheumatology, University of Alberta School of Medicine and Dentistry, Edmonton, Canada.
Division Immunology-Rheumatology, Stanford University, Palo Alto, California, USA.
Eur J Rheumatol. 2018 Dec;5(4):216-223. doi: 10.5152/eurjrheum.2018.18162. Epub 2018 Oct 30.
Matching-adjusted indirect comparison was used to assess the comparative effectiveness of secukinumab 150 mg and adalimumab 40 mg in biologic-naïve patients with ankylosing spondylitis (AS) for up to 1 year.
Pooled individual patient data from the secukinumab arms of MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375) trials (n=197) were matched against the ATLAS (NCT00085644) adalimumab population (n=208). Logistic regression analysis was used to determined weights to match for age, sex, Bath AS Functional Index, C-reactive protein levels, and previous tumor necrosis factor inhibitor therapy. Recalculated Assessment of SpondyloArthritis International Society (ASAS) 20 and 40 responses at weeks 8, 12, 16, 24, and 52 from MEASURE 1/2 (effective sample size=120) were compared with those of ATLAS. Anchored (placebo-adjusted) comparisons were possible until week 12, and unanchored (non-placebo-adjusted) comparisons were necessary thereafter.
For placebo-anchored ASAS 20 and 40 comparisons up to week 12, there were no differences between secukinumab and adalimumab. For unanchored comparisons at week 16, ASAS 20 was higher for secukinumab [odds ratio 1.60 (95% confidence interval, 1.01-2.54); p=0.047]; at week 24, ASAS 20 and 40 were higher for secukinumab [1.76 (1.11-2.79); p=0.017 and 1.79 (1.14-2.82); p=0.012, respectively]; and at week 52, ASAS 40 was higher for secukinumab [1.54 (1.06-2.23); p=0.023] than for adalimumab.
There were no differences observed in placebo-adjusted ASAS 20 and 40 responses up to 12 weeks between secukinumab- and adalimumab-treated patients with ankylosing spondylitis. After week 12, secukinumab demonstrated signs of greater improvement in non-placebo-adjusted ASAS 20 and 40 responses than adalimumab.
采用匹配调整间接比较法,评估在生物制剂初治的强直性脊柱炎(AS)患者中,150mg司库奇尤单抗与40mg阿达木单抗长达1年的比较疗效。
将MEASURE 1(NCT01358175)和MEASURE 2(NCT01649375)试验中司库奇尤单抗组的汇总个体患者数据(n = 197)与ATLAS(NCT00085644)阿达木单抗组人群(n = 208)进行匹配。采用逻辑回归分析确定年龄、性别、巴斯强直性脊柱炎功能指数、C反应蛋白水平和既往肿瘤坏死因子抑制剂治疗情况的匹配权重。重新计算MEASURE 1/2在第8、12、16、24和52周时的国际脊柱关节炎协会(ASAS)20和40反应(有效样本量 = 120),并与ATLAS组进行比较。在第12周之前可以进行锚定(安慰剂调整)比较,此后则需要进行非锚定(非安慰剂调整)比较。
在第12周之前进行的安慰剂锚定ASAS