Arthrit Care Res：药物来氟米特安全和有效地治疗银屑病关节炎

2012年10月15日 讯 /生物谷BIOON/ --根据一项于2012年10月6日在线刊登在Arthritis Care & Research期刊上的研究，在日常的临床实践中，来氟米特(leflunomide)能够有效地治疗患有银屑病关节炎(psoriatic arthritis, PsA)的病人。

为了评估来氟米特的有效性和安全性，来自德国法兰克福大学的Frank Behrens博士和同事们开展了一项前瞻性的为期24周的跨国性观察研究。这项研究涉及514名开始接受来氟米特治疗的患有活动性PsA疾病的病人(平均年龄为50.7岁，平均疾病持续时间6.1年)。银屑病关节炎反应标准(Psoriatic Arthritis Response Criteria, PsARC)被用来评估疾病反应情况。

研究人员发现在初步的疗效分析当中，在第24周，在440名病人当中有380人(86.4%)产生PsARC反应，就像临床医生对病人的疲劳、疼痛、皮肤病、指炎和指甲病变进行全局性评估时那样，他们发现压痛与肿胀关节得分和数量也显著性地发生改善。治疗中断率(rate of treatment discontinuation)为12.3%。62名病人(12.1%)发生药物不良反应，其中3人被认为产生严重性不良反应(2人体内的肝脏酶活性增加，1人出现高血压危象)。

论文作者们写道，“在这些数据的基础上，我们可以得出结论：在日常的临床实践中，来氟米特能够有效地和安全地治疗PsA疾病。它能够减轻关节炎、皮肤病和其他疾病表征。另外，可控的安全特性和相对较低的价格使得来氟米特成为一种治疗PsA疾病的有价值的选择。”

赛诺菲安万特公司(Sanofi-aventis)资助了这项研究。(生物谷Bioon.com)

doi: 10.1002/acr.21848
PMC:
PMID:

Leflunomide in psoriatic arthritis: Results from a large european prospective observational study

Frank Behrens, Christoph Finkenwirth, Karel Pavelka, Jiří Štolfa, AlenkaŠipek-Dolnicar, Diamant Thaçi, Harald Burkhardt

Objective:
To determine the “real-world” clinical effectiveness and safety of leflunomide in patients with psoriatic arthritis (PsA).

Methods:
This prospective, multinational 24-week observational study involved adult patients with active PsA who initiated treatment with leflunomide.Patients were evaluated at baseline, 12 weeks, and 24 weeks.The primary outcome was response as assessed by Psoriatic Arthritis Response Criteria (PsARC) in patients with pre- and post-treatment data.A modified PsARC response analysis included patients with joint counts, but no severity scores.Other effectivenessevaluations included global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions.All patients were evaluated for safety.

Results:
A total of 514 patients were enrolled in this study (mean age, 50.7 years; mean disease duration,6.1 years). In the primary effectivenessanalysis, 380 of 440patients (86.4%; 95% confidence interval 82.8% – 89.4%) achieved a PsARC response at 24 weeks. Significant improvements were observed in tender and swollen joint scores and counts, patient and physician global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions.The discontinuation rate was 12.3%.Ninety-eight adverse drug reactions occurred in 62 (12.1%) patients; 3 were serious (2 increased liver enzymes, 1 hypertensive crisis).

Conclusion:
Leflunomide is an effective and well toleratedoption for PsA in daily clinical practice, with beneficial effects on peripheral arthritis and on other PsA manifestations, including pain, fatigue, dactylitis, and skin disease. © 2012 by the American College of Rheumatology

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