de Vlam Kurt, Boone Caroline, The Prove Study Group A
Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Medical Department, Pfizer SA/NV, Brussels, Belgium.
Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23.
To describe the long-term adherence, efficacy, and safety in patients with psoriatic arthritis (PsA) treated with etanercept (ETN) in a daily clinical setting in Belgium.
The PROVE study was a prospective, multi-centre, open-label, observational study in patients with active PsA who had previously failed disease-modifying anti-rheumatic drugs. Patients were treated with ETN prescribed by their physician and adherence was monitored over 66 months.
A total of 303 patients were enrolled (polyarticular-type n=264; oligoarticular-type n=39). 156 (51.5%) patients adhered to the treatment until the end of the study. The mean study duration was 4.0 (SD, 1.9) years. The most common reasons for discontinuing were non-response (35.9%), patient lost to follow-up (20.7%), and reasons unrelated to ETN (20.0%). Males adhered to treatment significantly longer than females (5.0 vs. 3.9 years; p<0.0001). After 6 months, 49.0% of patients with active synovitis at the start of the study had zero joints with synovitis, and this proportion increased to 77.6% by month 66 (p<0.001 for all time points vs. baseline). In polyarticular-type patients, the mean total Health Assessment Questionnaire (HAQ) score (0-60) decreased from 27.0 (95% CI 25.9-28.1) to 9.7 (8.5-10.9; 64.8% improvement; p<0.001) after 6 months and to 7.7 (6.2-9.3; 66.6% improvement; p<0.001) after 66 months. Treatment-related adverse events were reported in 177 (58.8%) of patients, and 53 (17.6%) patients reported serious adverse events related to treatment.
In these patients with active PsA from daily clinical practice, adherence to ETN was high observed over 5.5 years and it was well tolerated.
描述在比利时日常临床环境中接受依那西普（ETN）治疗的银屑病关节炎（PsA）患者的长期依从性、疗效和安全性。
PROVE研究是一项针对先前使用改善病情抗风湿药物治疗失败的活动性PsA患者的前瞻性、多中心、开放标签观察性研究。患者接受医生开具的ETN治疗，并在66个月内监测依从性。
共纳入303例患者（多关节型n = 264；少关节型n = 39）。156例（51.5%）患者坚持治疗至研究结束。平均研究时长为4.0（标准差，1.9）年。停药的最常见原因是无反应（35.9%）、失访（20.7%）以及与ETN无关的原因（20.0%）。男性坚持治疗的时间显著长于女性（5.0年对3.9年；p < 0.0001）。6个月后，研究开始时患有活动性滑膜炎的患者中，49.0%的患者滑膜炎关节数为零，到66个月时这一比例增至77.6%（所有时间点与基线相比，p < 0.001）。在多关节型患者中，健康评估问卷（HAQ）总分（0 - 60）在6个月后从27.0（95%置信区间25.9 - 28.1）降至9.7（8.5 - 10.9；改善64.8%；p < 0.001），在第66个月时降至7.7（6.2 - 9.3；改善66.6%；p < 0.001）。177例（58.8%）患者报告了与治疗相关的不良事件，53例（17.6%）患者报告了与治疗相关的严重不良事件。
在这些来自日常临床实践的活动性PsA患者中，观察到5.5年期间对ETN的依从性较高，且耐受性良好。
