Three-Year Results of Tapering Tumor Necrosis Factor Inhibitor to Withdrawal Compared to Stable Tumor Necrosis Factor Inhibitor Among Patients With Rheumatoid Arthritis in Sustained Remission: A Multicenter Randomized Trial.

We assessed the effect of tapering TNFi to withdrawal versus continued stable TNFi on flare-free survival and joint damage progression over three years.

我们评估了将TNFi减量至停药与继续稳定使用TNFi相比，三年内无发作生存率和关节损伤进展的影响。

Methods

ARCTIC REWIND was a multicenter open-label, noninferiority trial that included patients with RA in remission for ≥12 months taking stable TNFi therapy.

ARCTIC REWIND 是一项多中心开放标签、非劣效试验，纳入了接受稳定肿瘤坏死因子抑制剂（TNFi）治疗且类风湿关节炎（RA）缓解≥12个月的患者。

Patients were randomized 1:1 to taper TNFi to withdrawal or continue stable treatment.

患者按1:1的比例随机分为两组，一组逐渐减量直至停用TNFi，另一组继续维持稳定治疗。

The primary end points of the current study were flare-free survival and radiographic progression over three years.

本研究的主要终点是三年内的无发作生存和放射学进展。

Flare-free survival was analyzed by Kaplan-Meier methods, flare rates were analyzed by Cox regression, and radiographic progression was analyzed by logistic mixed-effects models.

无发作生存通过Kaplan-Meier方法进行分析，发作率通过Cox回归分析，放射学进展通过逻辑混合效应模型进行分析。

Results

Of 99 randomized patients, 92 received the allocated therapy, and 80 completed the three-year follow-up.

在99名随机患者中，92名接受了分配的治疗，80名完成了三年的随访。

The mean baseline Disease Activity Score based on the 44 joint count was 0.8, and conventional synthetic disease-modifying antirheumatic drug comedication was used by 90% of patients.

基于44个关节计数的平均基线疾病活动度评分为0.8，90%的患者使用了传统合成疾病修饰性抗风湿药物作为联合治疗。

After three years, 25% (95% confidence interval[CI] 13%-38%) remained flare free in the tapering TNFi group, compared to 85% (95% CI 70%-93%) in the stable group, and the corresponding hazard ratiofor flare was 9.4 (95% CI 3.9-22.8, P < 0.0001).

三年后，25%（95%置信区间[CI] 13%-38%）的患者在逐渐减量TNFi组中未出现爆发性加重，而在稳定组中这一比例为85%（95% CI 70%-93%），相应的爆发性加重风险比为9.4（95% CI 3.9-22.8，P < 0.0001）。

In the tapering group, 6 of 41 (15%) experienced radiographic progression, compared with 3 of 38 (8%) in the stable group (risk difference 6.7%, 95% CI -7.1% to 20.5%, P = 0.3).

在逐渐减量组中，41名患者中有6名（15%）出现了放射学进展，而在稳定组中38名患者中有3名（8%）出现了放射学进展（风险差异6.7%，95% CI -7.1%至20.5%，P = 0.3）。

Adverse events occurred in 81% of the patients in the tapering group and 89% of the patients in the stable group.

在逐渐减量组中，81%的患者出现了不良事件，在稳定组中，89%的患者出现了不良事件。

Conclusions

In contrast to those receiving stable TNFi treatment, a minority of patients with RA in remission tapering TNFi to withdrawal remained flare free over three years.

与接受稳定TNFi治疗的患者相比，少数处于缓解期的类风湿关节炎患者逐渐减量TNFi至停药后在三年内保持无发作状态。

There was no statistically significant difference in radiographic progression between the groups.

两组间放射学进展无统计学显著差异。