Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial
Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial
复制标题
DOI：
10.1111/j.1365-2133.2008.08564.x
复制
发表时间：
2008-06-01
影响因子：
10.3
通讯作者：
Girolomoni, G.
中科院分区：
文献类型：
--
作者：
Gisondi, P.;Del Giglio, M.;Girolomoni, G.
联合治疗可以增加疗效，同时减少剂量和副作用的个别代理。没有随机对照试验已出版的生物制剂与传统agents for psorias.Objectives相结合，探讨阿维A和依那西普在治疗中重度慢性斑块状psorias.Methods的疗效和安全性的协会，24周，随机，对照，药物盲法试点试验进行。将60例中重度慢性斑块状银屑病成人患者随机分为3组，分别接受依那西普25 mg每周2次皮下注射、口服阿维A 0.4 mg/kg/d或依那西普25 mg每周1次联合阿维A 0.4 mg/kg/d。主要终点为第24周时PsAI面积和严重程度指数（PASI）较基线改善75%或以上（PASI 75）。结果第24周时，依那西普组22例患者中有10例（45%）达到PASI 75应答，阿维A组20例中有6例（30%），依那西普+阿维A组18例中有8例（44%）（两个依那西普组与阿维A单药组相比P = 0.001）。PASI较基线改善≥ 50%的患者分别为15/22例（68%）、10/20例（50%）和12/18例（67%）（P = 0.001）。结论依那西普25 mg每周1次和阿维A 0.4 mg kg（-1）每日1次联合治疗方案与依那西普25 mg每周2次疗效相当，且优于阿维A单药治疗。虽然需要更大规模的研究来证实这些结果，但依那西普/阿维A联合治疗中重度慢性斑块状银屑病具有几个优势。
Background Combination treatments may increase efficacy while reducing dosages and side-effects of individual agents. No randomized controlled trials have been published combining biologics with conventional agents for psoriasis.Objectives To investigate the efficacy and safety of the association of acitretin and etanercept in the treatment of moderate to severe chronic plaque psoriasis.Methods A 24-week, randomized, controlled, investigator-blinded pilot trial was conducted. Sixty adult patients with moderate to severe chronic plaque psoriasis were randomized into three groups to receive etanercept 25 mg twice weekly subcutaneously, oral acitretin 0.4 mg kg(-1) daily or etanercept 25 mg once weekly plus acitretin 0.4 mg kg(-1) daily. The primary end point was a 75% or greater improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI 75) at week 24.Results At week 24, PASI 75 response was achieved by 10 of 22 patients in the etanercept group (45%), six of 20 in the acitretin group (30%) and eight of 18 (44%) in the group treated with etanercept plus acitretin (P = 0.001 for both etanercept groups compared with acitretin alone). A 50% or greater improvement from baseline in PASI was achieved by 15 of 22 (68%), 10 of 20 (50%) and 12 of 18 (67%) patients, respectively (P = 0.001). The safety profiles of the three groups were similar.Conclusions A combined therapeutic regimen with etanercept 25 mg once weekly and acitretin 0.4 mg kg(-1) daily is as effective as etanercept 25 mg twice weekly, and more effective than acitretin alone. Although larger studies are needed to confirm these results, the etanercept/acitretin association could offer several advantages in the therapy of moderate to severe chronic plaque psoriasis.