原文

译文

Acta Derm Venereol. 2011 Jan;91(1):44-9.

Tolerability and safety of biological therapies for psoriasis in daily clinical practice: a study of 103 italian patients.

Brunasso AM, Puntoni M, Salvini C, Delfino C, Curcic P, Gulia A, Massone C.

Department of Dermatology, Medical University of Graz, Auenbruggerplatz 8, A-8036 Graz, Austria.

Abstract

Studies comparing the safety and tolerability of biological therapies for psoriasis in the long-term and in daily clinical practice are lacking. Most published studies are of selected patients with short-term (3-6 months) follow-up. We performed a retrospective cohort study of 103 patients in order to describe the frequency and the clinical features of adverse events, and to evaluate and compare the tolerability and safety of efalizumab, etanercept, infliximab, and adalimumab in clinical practice. A total of 136 courses of biological therapies were administered, with a mean duration of 16 months/patient; 55 patients received efalizumab, 45 etanercept, 33 infliximab, and 3 adalimumab. Infliximab had an incidence rate ratio of suspension due to severe adverse events 5.9 times (95% confidence interval (95% CI) 1.9-18, p < 0.001) higher than etanercept and 9.8 times (95% CI 3.2-30.1, p < 0.001) higher than efalizumab. Safety profiles for efalizumab and etanercept were more favourable than for infliximab. Concerning tolerability, we found that more patients responded to infliximab, but long-term tolerability was higher for both efalizumab and etanercept due to the better safety profile and a higher compliance to therapy.

在常规临床工作中生物制剂治疗银屑病的耐受性和安全性：一项103例意大利患者的研究

Brunasso AM, et al.Acta Derm Venereol. 2011 Jan;91(1):44-9.

目前缺乏有关在常规临床工作中长期使用生物制剂治疗银屑病的安全性和耐受性的研究。大部分已发表的研究选择患者进行短期随访（3-6个月）。我们回顾性分析103例患者，旨在了解副反应的发生率和临床特点，评价和比较依法珠单抗、依那西普、英夫利昔单抗和阿达木单抗在临床应用中的耐受性和安全性。共纳入136个疗程的生物制剂治疗，平均16个月/患者；55例患者使用依法珠单抗，45例使用依那西普，33例使用英夫利昔单抗，3例使用阿达木单抗。英夫利昔单抗因严重不良事件而停药的发生率比依那西普高5.9倍（95% CI 1.9-18, p < 0.001），比依法珠单抗高9.8倍（95% CI 3.2-30.1, p < 0.001）。依法珠单抗和依那西普的安全性优于英夫利昔单抗。关于耐受性，我们发现虽然英夫利昔单抗疗效更好，但由于依法珠单抗和依那西普的安全性和依从性更好，这两种药物的长期耐受性更好。