Objective

In patients with rheumatoid arthritis (RA) in sustained remission, tapering of biological disease-modifying anti-rheumatic drugs can be considered. Tapering has already been investigated, but its feasibility remains to be determined. Therefore, we explored the feasibility of tapering etanercept in RA in a setting close to practice.

Method

Patients with RA in 28-joint Disease Activity Score (DAS28) remission (≥ 6 months) and treated with etanercept 50 mg weekly (≥ 1 year) were included in the pragmatic 1 year open-label multicentre randomized controlled TapERA (Tapering Etanercept in Rheumatoid Arthritis) trial. Patients were assigned to continue etanercept weekly or to taper to every other week (EOW). Patients who lost remission [DAS28–C-reactive protein (CRP) ≥ 2.6] were re-escalated to etanercept weekly. The primary outcome was the proportion of patients maintaining DAS28-CRP remission for 6 months.

Results

Sixty-six patients were randomized to etanercept weekly (n = 34) or EOW (n = 32). After 6 months, 26/34 patients (76%) in the weekly and 19/32 (59%) in the EOW group maintained disease control (p = 0.136). In the EOW group, 20/32 patients (63%) remained on their tapered treatment during the trial. Two patients reintroduced weekly etanercept themselves. Ten patients were re-escalated to etanercept weekly by the rheumatologist, after a median (interquartile range) interval of 3.0 (2.0–6.0) months. Among these patients, 7/10 regained remission after re-escalation, four of them at the next study visit.

Conclusions

Although non-inferiority could not be demonstrated, tapering of etanercept to EOW appeared feasible in patients in sustained remission.

中文翻译：

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持续缓解的类风湿性关节炎患者逐渐减量依那西普是可行的：一项实用的随机对照试验

客观的

对于持续缓解的类风湿关节炎 (RA) 患者，可以考虑逐渐减量生物疾病缓解抗风湿药物。已经对逐渐变细进行了研究，但其可行性仍有待确定。因此，我们在接近实践的环境中探讨了在 RA 中逐渐减少依那西普的可行性。

方法

28 关节疾病活动评分 (DAS28) 缓解（≥ 6 个月）且每周接受依那西普 50 mg 治疗（≥ 1 年）的 RA 患者被纳入务实的 1 年开放标签多中心随机对照 TapERA（类风湿中逐渐减量依那西普关节炎）试验。患者被分配每周继续使用依那西普或逐渐减量至每隔一周 (EOW)。失去缓解的患者 [DAS28–C 反应蛋白 (CRP) ≥ 2.6] 每周重新升级至依那西普。主要结果是维持 DAS28-CRP 缓解 6 个月的患者比例。

结果

66 名患者被随机分配到依那西普每周一次 (n = 34) 或 EOW (n = 32)。6 个月后，每周 26/34 名 (76%) 患者和 EOW 组 19/32 (59%) 名患者保持疾病控制 (p = 0.136)。在 EOW 组中，20/32 名患者 (63%) 在试验期间继续接受逐渐减量的治疗。两名患者自己每周重新服用依那西普。在 3.0 (2.0–6.0) 个月的中位（四分位数范围）间隔后，风湿病学家每周将 10 名患者重新升级为依那西普。在这些患者中，7/10 在重新升级后恢复缓解，其中 4 人在下一次研究访视时。

结论

虽然无法证明非劣效性，但在持续缓解的患者中，依那西普逐渐减少至 EOW 似乎是可行的。