BMJ:中轴性脊柱关节炎靶向治疗的疗效真的要优于普通治疗吗?

2021-10-18 MedSci原创 MedSci原创

该试验并未证明TC/T2T方法在主要疗效方面明显优于UC,而许多次要疗效结果支持TC/T2T方法,二者具有相似的安全性,并且从1年的社会健康经济角度来看是有利的。

中轴性脊柱关节炎(axSpA)的活动性是通过测量炎症指数来评估的,包括患者报告的完全强直性脊柱炎疾病活动指数(BASDAI)或强直性脊柱炎疾病活动评分(ASDAS)。ASDAS包括患者报告结果(PRO)和C反应蛋白(CRP),是axSpA的首选结果。T2T已被证明是一种有效的治疗类风湿关节炎和银屑病关节炎等风湿性炎症性疾病的方法。

对axSpA的治疗建议为:与常规治疗(UC)相比,建议应用T2T治疗,虽然专家已经推荐在日常实践中使用TC/T2T治疗axSpA患者,但目前还没有研究评估TC/T2T治疗对axSpA患者的潜在益处。因此,本试验的目的是比较其与axSpA患者UC治疗的潜在益处。

本研究为实用、前瞻性、集群随机、对照、开放、为期1年的试验(NCT03043846)。18个中心被随机分组(1:1)。患者符合国际轴性脊柱炎协会(ASAS) axSpA标准,强直性脊柱炎疾病活动度评分(ASDAS) 2.1,接受非甾体抗炎药物非最佳治疗,且无生物学基础。

研究最后共纳入160例患者(80例/组)。平均(SD)年龄为37.9(11.0)岁,病程为3.7(6.2)年;51.2%为男性。纳入时ASDAS为3.0(0.7),ASAS-HI为8.6(3.7)。47.3%的TC/T2T组和36.1%的UC组ASAS-HI改善了30%(无显著性)。所有次要疗效结果在TC/T2T组更为常见,尽管并非所有结果都具有统计学意义。双臂的安全性相似。从社会角度来看,与UC相比,TC/T2T增加了0.04 QALY,节省了472。

在最后一次研究来访时(第48周)估计疗效结果

总之,该试验并未证明TC/T2T方法在主要疗效方面明显优于UC,而许多次要疗效结果支持TC/T2T方法,二者具有相似的安全性,并且从1年的社会健康经济角度来看是有利的。

参考文献: Molto A, et al. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis 2021;80:1436–1444. doi:10.1136/annrheumdis-2020-219585

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    2021-10-20 lmm397
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