Spacing of a TNF inhibitor or dose reduction of methotrexate vs continued treatment in patients with rheumatoid arthritis in remission or low disease activity: a randomised, controlled trial (SORAIRO trial).

Methods

The SORAIRO trial was a multicentre, open-label, randomised, noninferiority study.

SORAIRO试验是一项多中心、开放标签、随机、非劣效性研究。

Patients who had been in remission or low disease activity based on the Clinical Disease Activity Index (CDAI) in the preceding phase III trial of ozoralizumab, a next-generation TNF inhibitor, were enrolled.

在先前的第三代肿瘤坏死因子抑制剂奥扎拉单抗的III期试验中，基于临床疾病活动指数（CDAI）处于缓解或低疾病活动状态的患者被纳入研究。

The precalculated sample size was 141.

预先计算的样本量为141。

Patients were randomised into continued treatment, ozoralizumab spacing, or methotrexate dose reduction groups.

患者被随机分配到继续治疗组、ozoralizumab间隔组或甲氨蝶呤减量组。

The primary endpoint was a noninferiority of low disease activity maintenance at week 48 with a prespecified noninferiority margin of -18%.

主要终点是第48周维持低疾病活动度的非劣效性，预设的非劣效性边界为-18%。

Results

A total of 144 patients were analysed.

共分析了144名患者。

The mean age was 58.2 years, 75.0% were female, and the mean CDAI was 2.70 with 61.8% in remission.

平均年龄为58.2岁，75.0%为女性，平均CDAI评分为2.70，其中61.8%的患者处于缓解状态。

The low disease activity at week 48 was 97.9% in the continued treatment group, 79.2% in the ozoralizumab spacing group (difference, -21.6; 95% CI, -39.9 to -5.7), and 72.7% in the methotrexate dose reduction group (difference, -30.4; 95% CI, -54.0 to -10.5).

在第48周，持续治疗组的疾病活动度低为97.9%，奥佐拉利单抗间隔给药组为79.2%（差异，-21.6；95%置信区间，-39.9至-5.7），甲氨蝶呤剂量减少组为72.7%（差异，-30.4；95%置信区间，-54.0至-10.5）。

In the baseline remission subgroup, remission maintenance rates were comparable in the 3 groups (77.4%, 76.7%, 79.2%, respectively).

在基线缓解亚组中，3组的缓解维持率相当（分别为77.4%，76.7%，79.2%）。

No significant differences were demonstrated in changes in the Health Assessment Questionnaire Disability Index and modified total Sharp score.

在健康评估问卷残疾指数和改良总Sharp评分的变化中，未显示出显著差异。

Adverse events occurred in 68.0%, 59.2%, and 58.0%, respectively.

分别有68.0%、59.2%和58.0%的患者出现了不良事件。

Conclusions

Treatment tapering may not be feasible in patients with low disease activity, whereas both extending the TNF inhibitor interval and reducing the methotrexate dose may be reasonable options for patients in remission.

对于疾病活动度低的患者，治疗减量可能不可行，而对于处于缓解期的患者，延长肿瘤坏死因子抑制剂的用药间隔和减少甲氨蝶呤剂量可能是合理的选择。