Objective Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. Methods Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. Results Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo). Conclusions In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports. Trial registration number NCT01925768; Results.

中文翻译：

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阿普斯特单药治疗银屑病关节炎患者的早期和持续疗效：IIIB 期随机对照试验 (ACTIVE)

目的 评估 apremilast 在第 2 周开始的各种银屑病关节炎 (PsA) 表现中对 PsA 生物学初治患者的疗效。方法 患者随机 (1:1) 接受阿普斯特 30 mg 每天两次或安慰剂。在第 16 周，肿胀和压痛关节计数未改善≥10% 的患者符合早期逃逸的条件。在第 24 周，所有患者都接受了阿普斯特至第 52 周。 结果 在 219 名随机患者中（阿普斯特：n=110；安慰剂：n=109），在第 16 周（主要结果）观察到显着更高的美国风湿病学会 20 反应阿普斯特与安慰剂 (38.2% (42/110) vs 20.2% (22/109)；P=0.004)；第 2 周（第一次评估）的反应率为 16.4% (18/110) 与 6.4% (7/109) (P=0.025)。其他疗效结果的改善，包括使用 C 反应蛋白 (CRP) 的 28 关节计数疾病活动评分 (DAS-28)、肿胀关节计数、健康评估问卷 - 残疾指数 (HAQ-DI)、附着点炎和晨僵严重程度，在第 2 周用阿普斯特观察. 在第 16 周，与安慰剂相比，阿普斯特显着降低 PsA 疾病活动，DAS-28 (CRP) (P<0.0001)、HAQ-DI (P=0.023) 和 Gladman 附着点炎指数 (P=0.001) 发生变化。通过持续治疗直到第 52 周，改善得以保持。超过 52 周，apremilast 的安全性特征与之前银屑病和 PsA 的 3 期研究一致。在第 0-24 周，方案定义的腹泻发生率为 11.0%（阿普司特）和 8.3%（安慰剂）；严重不良事件发生率为 2.8%（阿普司特）和 4.6%（安慰剂）。结论 在未使用生物学的 PsA 患者中，在第 2 周观察到阿普斯特的作用开始并持续到第 52 周。安全性与之前的报告一致。试验注册号NCT01925768；结果。