Coates Lucy, Packham Jonathan C, Creamer Paul, Hailwood Sarah, Bhalla Ashley S, Chakravarty Kuntal, Mulherin Diamuid, Taylor Gordon, Mattey Derek L, Bhalla Ashok K
Department of Rheumatology, Tameside Hospital, Ashton-Under-Lyne, Lancashire, UK.
Haywood Rheumatology Centre, Stoke on Trent, UK.
Clin Exp Rheumatol. 2017 May-Jun;35(3):445-451. Epub 2017 Jan 4.
A prospective, double blind, randomised, placebo controlled trial over 2 years was performed to test the efficacy of alendronate, an oral aminobisphosphonate, in improving symptoms and arrest disease progression in patients with mild to severe ankylosing spondylitis (AS).
180 patients with AS were randomised to receive weekly alendronate 70 mg or placebo (1:1 randomisation). BAS-G was the primary outcome measure with Bath indices as secondary outcomes. Vertebral x-rays were performed at 0 and 24 months. Biomarkers (including CRP, IL-1beta, IL6, VEGF, MMP-1, and MMP-3) were collected during the first 12 months.
There was no significant difference between the placebo and treatment groups in any of the recorded outcomes over the 2 years including clinical indices, biomarkers, and radiology. The change in BAS-G, the primary outcome measure, was -0.21 for the treatment group and -0.42 for the placebo group p=0.57. Change in all other clinical outcome measures were also non-significant; BASDAI p=0.86, BASFI p=0.37, BASMI p=0.021. Sub-group analysis of those subjects with a baseline BASDAI >4 were also non-significant.
This prospective study demonstrates that alendronate 70mg weekly for 2 years was no more efficacious than placebo in improving clinical or laboratory measures of disease activity or measures of physical impact in subjects with mild to severe active AS.
ID SRCTN12308164, registered on 15.12.2015.
开展一项为期2年的前瞻性、双盲、随机、安慰剂对照试验，以测试口服氨基双膦酸盐阿仑膦酸钠在改善轻至重度强直性脊柱炎（AS）患者症状及阻止疾病进展方面的疗效。
180例AS患者被随机分为两组，分别接受每周70mg阿仑膦酸钠或安慰剂治疗（1:1随机分组）。以BAS - G作为主要结局指标，以巴斯指数作为次要结局指标。在0个月和24个月时进行脊椎X线检查。在最初12个月内收集生物标志物（包括CRP、IL - 1β、IL6、VEGF、MMP - 1和MMP - 3）。
在2年期间，安慰剂组和治疗组在任何记录的结局方面均无显著差异，包括临床指标、生物标志物和放射学检查结果。主要结局指标BAS - G的变化，治疗组为 - 0.21，安慰剂组为 - 0.42，p = 0.57。所有其他临床结局指标的变化也无统计学意义；BASDAI p = 0.86，BASFI p = 0.37，BASMI p = 0.021。对基线BASDAI>4的受试者进行亚组分析，结果也无统计学意义。
这项前瞻性研究表明，对于轻至重度活动性AS患者，每周服用70mg阿仑膦酸钠，持续2年，在改善疾病活动的临床或实验室指标或身体影响指标方面并不比安慰剂更有效。
ID SRCTN12308164，于2015年12月15日注册。
