Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)
Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)
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DOI：
10.1136/annrheumdis-2014-206696
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发表时间：
2016-01-01
影响因子：
27.4
通讯作者：
Tubach, Florence
中科院分区：
文献类型：
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作者：
Fautrel, Bruno;Thao Pham;Tubach, Florence
目的比较肿瘤坏死因子受体阻滞剂递增间隔注射(S-ARM)和维持注射(M-ARM)对类风湿关节炎(RA)缓解期患者的疗效。方法：本研究为一项为期18个月的等效性试验，患者接受稳定剂量的依那西普或阿达单抗治疗1年，缓解期患者的28关节疾病活动度评分(DAS28)为6个月。患者被随机分成两组：维持或每3个月注射间隔50%，直到完全停止。在复发的情况下，间隔时间被反转到以前的间隔，并最终在缓解后重新尝试。主要结果是基于线性混合效应模型(等效区间设置为+/-30%)的DAS28斜率的标准化差异。结果和73例患者分别纳入S臂和M臂，低于计划。S组停药39.1%，停药35.9%，满剂量维持20.3%。没有证明等价性，标准化差异为19%(95%可信区间-5%至46%)。复发以S组多见(76.6%vs46.5%，P=0.0004)。结论逐渐减少并不等同于维护策略，在不影响结构损伤进展的情况下导致更多的复发。需要进一步的研究来确定哪些患者可以从这种与大幅节省成本相关的策略中受益。
Tumour necrosis factor (TNF)-blocker tapering has been proposed for patients with rheumatoid arthritis (RA) in remission.Objective The trial aims to compare the effect of progressive spacing of TNF-blocker injections (S-arm) to their maintenance (M-arm) for established patients with RA in remission.Methods The study was an 18-month equivalence trial which included patients receiving etanercept or adalimumab at stable dose for >= 1 year, patients in remission on 28-joint Disease Activity Score (DAS28) for >= 6 months and patients with stable joint damage. Patients were randomised into two arms: maintenance or injections spacing by 50% every 3 months up to complete stop. Spacing was reversed to the previous interval in case of relapse, and eventually reattempted after remission was reachieved. The primary outcome was the standardised difference of DAS28 slopes, based on a linear mixed-effects model (equivalence interval set at +/-30%).Results 64 and 73 patients were included in the S-arm and M-arm, respectively, which was less than planned. In the S-arm, TNF blockers were stopped for 39.1%, only tapered for 35.9% and maintained full dose for 20.3%. The equivalence was not demonstrated with a standardised difference of 19% (95% CI -5% to 46%). Relapse was more common in the S-arm (76.6% vs 46.5%, p=0.0004). However, there was no difference in structural damage progression.Conclusions Tapering was not equivalent to maintenance strategy, resulting in more relapses without impacting structural damage progression. Further studies are needed to identify patients who could benefit from such a strategy associated with substantial cost savings.