Abatacept versus hydroxychloroquine for prevention of rheumatoid arthritis in individuals with palindromic rheumatism: a randomized open-label trial.

This randomized, open-label, multicenter trial aimed to assess whether 2 years of treatment with abatacept (n = 34; 125 mg subcutaneous injections weekly during the first year and every 2 weeks during the second year) compared with oral hydroxychloroquine (n = 36; 5 mg kg-1 per day) could reduce the frequency of RA development in individuals with palindromic rheumatism positive for rheumatoid factor and/or anticitrullinated protein antibody.

这项随机、开放标签、多中心试验旨在评估与口服羟氯喹（n = 36；每天每公斤体重5毫克）相比，使用阿巴塞普（n = 34；第一年每周皮下注射125毫克，第二年每两周一次）治疗2年，是否能减少类风湿因子和/或抗环瓜氨酸肽抗体阳性的回文性关节炎患者发展成RA的频率。

The primary outcome was the development of persistent arthritis that fulfilled the 2010 RA classification criteria of the American College of Rheumatology and the European Alliance of Associations for Rheumatology, as evaluated by the participant clinicians during the 24 months of follow-up.

主要结果是发展为持续性关节炎，该关节炎符合2010年美国风湿病学会和欧洲风湿病协会联合会的RA分类标准，由参与的临床医生在24个月的随访期间进行评估。

Secondary outcomes included the frequency, intensity and duration of joint attacks, the proportion of patients in remission and the frequency of adverse events.

次要结果包括关节发作的频率、强度和持续时间，缓解期患者的比率以及不良事件的频率。

In the primary analysis, in the modified full analysis set with failure imputation, 7 (20.6%) of the 34 participants treated with abatacept and 18 (50.0%) of the 36 participants treated with hydroxychloroquine developed RA during the 24 months of follow-up (P = 0.010; risk difference 29.4%, 95% confidence interval8.2 to 50.7), meeting the primary endpoint.

在主要分析中，使用失败估算的修正完整分析集，34名接受阿巴西普治疗的参与者中有7名（20.6%），36名接受羟氯喹治疗的参与者中有18名（50.0%）在24个月的随访期间发展为RA（P = 0.010；风险差异29.4%，95%置信区间8.2至50.7），满足主要终点。

Using the available-data-only approach, the corresponding figures were 3 (10.0%) of 30 individuals and 10 (35.7%) of 28 individuals, respectively (P = 0.019).

使用仅限可用数据的方法，相应的数字分别为30名个体中的3名（10.0%）和28名个体中的10名（35.7%）（P = 0.019）。

Compared with participants treated with hydroxychloroquine, participants treated with abatacept had a significantly longer time to progression to RA (hazard ratio0.27, 95% confidence interval0.07 to 0.96; log-rank test P = 0.0299).

与接受羟氯喹治疗的参与者相比，接受阿巴西普治疗的参与者进展到类风湿性关节炎的时间显著更长（风险比0.27，95% 置信区间0.07至0.96；对数秩检验P=0.0299）。

Abatacept was also associated with a reduced intensity of joint attacks and a higher frequency of symptom remission; however, there were no differences in the frequency of attacks between the two study drugs.

阿巴西普还与关节发作强度降低和症状缓解频率更高有关；然而，两种研究药物之间发作频率没有差异。

No relevant differences in the evolution of antimodified peptide and/or protein antibody titers were observed between the two treatment arms.

两组治疗方案在抗修饰肽和/或蛋白抗体滴度的演变中未观察到相关差异。

Both drugs were well tolerated.

两种药物均耐受性良好。

In patients with seropositive palindromic rheumatism, compared with hydroxychloroquine, abatacept given for 2 years reduced the risk of progression to RA and improved symptoms.

在血清阳性回文性关节炎患者中，与羟氯喹相比，给予阿巴塞普2年可降低进展为类风湿性关节炎的风险并改善症状。

ClinicalTrials.gov identifier NCT03669367 and EudraCT no. 2017-004543-20.

ClinicalTrials.gov注册号NCT03669367和EudraCT编号2017-004543-20。