INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France
Pitié Salpêtrière Hospital, Rheumatology Department, AP-HP, Paris, France.
Ann Rheum Dis. 2024 Oct 21;83(11):1480-1488. doi: 10.1136/ard-2024-225833.
Oligoarticular psoriatic arthritis (PsA) is frequent but rarely studied. The objective was to assess the efficacy of apremilast in early oligoarticular PsA.
FOREMOST (NCT03747939) was a phase 4 multicentre, randomised, double-blind, placebo-controlled trial. Patients had early (symptom duration ≤5 years) oligoarticular PsA (>1 but ≤4 swollen and >1 but ≤4 tender joints; 2-8 total active joints). Patients were randomised 2:1 to apremilast 30 mg two times per day or placebo for 24 weeks, with an early escape at week 16. The primary endpoint was the proportion of patients at week 16 who achieved minimal disease activity (MDA)-Joints (modification of MDA mandating ≤1 swollen joint and ≤1 tender joint) based on sentinel joints (those affected at baseline) with a combination of non-responder imputation and multiple imputations. Exploratory analysis assessed all joints.
Of 308 patients randomised (apremilast: n=203; placebo: n=105), mean (SD) PsA duration was 9.9 (10.2) months, mean (SD) age was 50.9 (12.5) years and 39.9% of patients were using a conventional synthetic disease-modifying antirheumatic drug. MDA-Joints (sentinel joints (primary endpoint) and all joints) were achieved by significantly more patients with apremilast (33.9% and 21.3%) vs placebo (16.0% and 7.9%) at week 16 (p=0.0008 and nominal p=0.0028, respectively). Greater improvements in patient-reported outcomes, clinical disease activity and skin involvement were also seen with apremilast versus placebo.
FOREMOST is the first randomised controlled trial designed for early oligoarticular PsA and showed apremilast improves clinical and patient-reported outcomes. This trial may inform the optimal management of PsA in these patients.
NCT03747939.
寡关节型银屑病关节炎（PsA）较为常见，但研究较少。本研究旨在评估阿普米司特治疗早期寡关节型 PsA 的疗效。
该项多中心、随机、双盲、安慰剂对照的 4 期临床试验（FOREMOST，NCT03747939）纳入了早期（病程≤5 年）寡关节型 PsA（>1 个但≤4 个肿胀关节和>1 个但≤4 个压痛关节；2-8 个总活跃关节）患者。患者按 2:1 随机分组，分别接受阿普米司特 30mg，每日 2 次或安慰剂治疗 24 周，在 16 周时有早期脱组。主要终点是在基于哨兵关节（基线时受影响的关节）的最小疾病活动度（MDA）-关节（需要≤1 个肿胀关节和≤1 个压痛关节）的患者比例，采用未应答者推断和多重插补的组合。探索性分析评估了所有关节。
308 例患者（阿普米司特组：n=203；安慰剂组：n=105）随机分组，平均（标准差）PsA 病程为 9.9（10.2）个月，平均（标准差）年龄为 50.9（12.5）岁，39.9%的患者正在使用传统合成的疾病修饰抗风湿药物。在第 16 周时，阿普米司特组（哨兵关节（主要终点）和所有关节）达到 MDA-Joints 的患者比例显著高于安慰剂组（33.9%和 21.3% vs 16.0%和 7.9%，p=0.0008 和名义 p=0.0028）。与安慰剂相比，阿普米司特组患者的报告结局、临床疾病活动度和皮肤受累也有更大的改善。
FOREMOST 是首个针对早期寡关节型 PsA 设计的随机对照试验，结果显示阿普米司特可改善临床和患者报告的结局。该试验可能为这些患者的 PsA 最佳治疗提供信息。
NCT03747939。
