Department of Dermatology, Hospital del Mar-Institut Mar d'Investigacions Mèdiques, Passeig Marítim, 25-29, 08003, Barcelona, Spain.
Department of Dermatology, Hospital de Bellvitge, Hospitalet de Llobregat, Spain.
Rheumatol Int. 2018 Nov;38(11):2037-2043. doi: 10.1007/s00296-018-4144-8. Epub 2018 Aug 24.
Although several randomized clinical trials and observational studies have evaluated the effectiveness, safety and drug survival of etanercept (ETN) in the treatment of psoriatic arthritis (PsA), long-term data regarding these aspects are currently scarce. For this reason, we sought to investigate the long-term survival and safety of ETN in PsA patients in 4 tertiary care Spanish hospitals over a 13-year observation period (from 2004 to 2017). The records of 85 PsA patients were reviewed. ETN showed an excellent survival profile, with rates of treatment discontinuation at 1, 3, 5 and 10 years of 15, 37, 46 and 59%, respectively. In our cohort, a trend toward longer drug survival in patients with shorter disease duration and those who were treated with ETN as their first biologic agent was observed. On the other hand, combination therapy with conventional disease-modifying antirheumatic drugs did not provide greater improvement on the long-term drug survival. Only 12% of the patients reported adverse events (AEs) during therapy, being most of them of mild to moderate intensity, and in only 7% AEs led to drug discontinuation. To the best of our knowledge, the present study shows the largest follow-up period of ETN-treated population analyzed in a real-life setting, and these results demonstrate the positive safety profile and long-term effectiveness of this biologic agent in the management of PsA patients.
虽然有几项随机临床试验和观察性研究评估了依那西普 (ETN) 在治疗银屑病关节炎 (PsA) 中的疗效、安全性和药物存活率,但目前关于这些方面的长期数据还很缺乏。出于这个原因,我们在 4 家西班牙三级护理医院进行了一项为期 13 年的观察研究,旨在调查依那西普治疗银屑病关节炎患者的长期生存和安全性。我们回顾了 85 名银屑病关节炎患者的记录。依那西普显示出极好的生存状况,1、3、5 和 10 年的停药率分别为 15%、37%、46%和 59%。在我们的队列中,观察到疾病持续时间较短和首次使用依那西普作为生物制剂的患者的药物存活率有延长的趋势。另一方面,联合使用传统的疾病修正抗风湿药物并没有在长期药物存活率上提供更大的改善。只有 12%的患者在治疗过程中报告了不良反应 (AE),其中大多数为轻至中度,只有 7%的 AE 导致药物停药。据我们所知,本研究显示了在真实环境中分析的接受依那西普治疗的人群中最长的随访时间,这些结果证明了这种生物制剂在治疗银屑病关节炎患者方面的积极安全性和长期疗效。