A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis.

No pharmacologic interventions have been approved for the prevention of RA in such at-risk individuals.

目前还没有任何药物干预措施被批准用于预防这些高风险个体的RA。

However, hydroxychloroquine (HCQ) is used without supporting clinical trial evidence.

然而，羟氯喹（HCQ）在没有支持性临床试验证据的情况下被使用。

Methods

In this phase 2 randomized trial, individuals at risk for RA with anti-CCP3 ≥2 times the upper limit of normal (ULN) were assigned to receive HCQ or placebo for 12 months, with up to 24 months of postdrug follow-up.

在这项II期随机试验中，有类风湿关节炎（RA）风险的个体，抗环瓜氨酸肽（anti-CCP3）水平≥正常上限（ULN）的2倍，被随机分配接受HCQ或安慰剂治疗12个月，随后进行长达24个月的药物后随访。

The primary outcome was the development of clinical RA, as defined in the protocol, at 36 months.

主要结果是在36个月时按照方案定义发展为临床类风湿关节炎(RA)。

Secondary outcomes included safety, development of inflammatory arthritis (IA), and participant-reported joint symptoms.

次要结果包括安全性、炎症性关节炎(IA)的发展以及参与者报告的关节症状。

Results

Of 144 randomized participants, 71 were assigned to HCQ and 73 to placebo.

在144名随机参与者中，71人被分配到羟氯喹组，73人被分配到安慰剂组。

In the modified intent-to-treat population, clinical RA occurred in 21 of 69 (30.4%) participants in the HCQ group and 24 of 73 (32.9%) in the placebo group.

在修改后的意向治疗人群中，羟氯喹组的69名参与者中有21人（30.4%）和安慰剂组的73名参与者中有24人（32.9%）发生了临床类风湿性关节炎。

The risk of clinical RA at 36 months was 0.336 with HCQ and 0.394 with placebo (difference -0.058; 95% confidence interval-0.336 to 0.220; P = 0.52).

在36个月时，使用羟氯喹的临床类风湿性关节炎（RA）风险为0.336，而使用安慰剂的风险为0.394（差异-0.058；95%置信区间-0.336至0.220；P=0.52）。

Results for IA were similar.

IA的结果与此相似。

The occurrence and severity of joint symptoms were not observed to differ between groups.

两组之间关节症状的发生率和严重程度未观察到差异。

Adverse eventincidencewas similar between groups.

两组之间的不良事件发生率相似。

Conclusions

In this trial involving individuals with anti-CCP3 levels ≥2 times the ULN, 12 months of HCQ did not prevent the development of clinical RA at 36 months.

在这项涉及抗CCP3水平≥2倍正常上限的个体的试验中，为期12个月的羟氯喹治疗并未能在36个月时预防临床类风湿关节炎的发展。