Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands
Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.
Ann Rheum Dis. 2020 Sep;79(9):1174-1181. doi: 10.1136/annrheumdis-2020-217485. Epub 2020 Jun 1.
To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.
评估两种逐渐递减策略的 2 年临床效果。第一种策略包括先逐渐减少传统合成疾病修饰抗风湿药物（csDMARDs）（即约 90%的甲氨蝶呤），然后再逐渐减少肿瘤坏死因子抑制剂（TNF-inhibitor），第二种策略则是先逐渐减少 TNF-inhibitor，然后再逐渐减少 csDMARDs。
这是一项多中心、单盲、随机对照试验，纳入了疾病活动度已连续 3 个月以上得到良好控制的类风湿关节炎（RA）患者，定义为使用 csDMARD 和 TNF-inhibitor 治疗后达到疾病活动评分（DAS）为 44 个关节≤2.4 和肿胀关节计数≤1。符合条件的患者被随机分为逐渐减少 csDMARDs 后再减少 TNF-inhibitor，或反之。主要结局是疾病发作次数。次要结局是无疾病缓解（DFR）、DAS、功能能力（健康评估问卷残疾指数（HAQ-DI））和放射学进展。
189 名患者被随机分为先减少 csDMARD（n=94）或 TNF-inhibitor（n=95）。24 个月后的累积发作率分别为 61%（95%CI 50%至 71%）和 62%（95%CI 52%至 72%）。先减少 csDMARD 的患者更常能够完成整个递减方案，并且达到 DFR 的比例也高于先减少 TNF-inhibitor 的患者（32%比 20%（p=0.12）和 21%比 10%（p=0.07））。随着时间的推移，DAS 和 HAQ-DI 的平均值以及放射学进展在两组之间没有差异（p=0.45、p=0.17、p=0.8）。
递减的顺序并不影响发作率、DAS 或 HAQ-DI。在已确诊的 RA 患者中，有 15%的患者可以达到 DFR，而先减少 csDMARDs 的患者达到 DFR 的比例略高。由于从临床角度来看效果相似，财务方面的考虑可能会影响先减少 TNF-inhibitor 的决策。
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