Driessen R J B, Boezeman J B, van de Kerkhof P C M, de Jong E M G J
Department of Dermatology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6525 GL Nijmegen, The Netherlands.
Br J Dermatol. 2009 Mar;160(3):670-5. doi: 10.1111/j.1365-2133.2008.09019.x. Epub 2008 Jan 28.
The course of biological treatment in clinical practice may be highly different from treatment schedules in clinical trials. Treatment modifications and patient characteristics may influence treatment safety and efficacy. So far, long-term results from the use of biological treatment in clinical practice are lacking.
To report short- and long-term efficacy and safety data on biologics, especially etanercept, used in daily clinical practice. Special attention has been paid to patient characteristics that may have influenced the response to therapy.
Prospectively collected registry data of all patients with psoriasis treated with biologics in the Radboud University Nijmegen Medical Centre outpatient clinic were used for analysis. Patient and treatment characteristics were surveyed. Efficacy and safety of etanercept for up to 3 years were analysed. Moreover, the influence of patient characteristics on etanercept treatment response was studied.
The analysed cohort, consisting of 118 patients, went through 142 treatment episodes in total. Patients treated with biologics had an extensive medical history. Optimization of biological treatment was established in various ways, including treatment switches and introduction of concomitant therapies. Short-term etanercept efficacy analysis showed a mean Psoriasis Area and Severity Index (PASI) improvement at week 24 of 59.7%. No significant influence of gender, age, baseline PASI, body mass index, number of previous systemic therapies or duration of psoriasis was found on week 24 efficacy results, although trends were discernible. The efficacy of etanercept remained stable for up to 156 weeks. Long-term daily practice treatment with etanercept was only occasionally accompanied by major safety concerns.
The current study demonstrates that etanercept is able to improve psoriasis symptoms for a considerable time, and that serious side-effects are infrequent. The influence of patient characteristics on treatment response is limited.
临床实践中生物治疗的疗程可能与临床试验中的治疗方案有很大差异。治疗调整和患者特征可能会影响治疗的安全性和有效性。到目前为止，临床实践中使用生物治疗的长期结果尚缺乏。
报告生物制剂，尤其是依那西普，在日常临床实践中的短期和长期疗效及安全性数据。特别关注了可能影响治疗反应的患者特征。
前瞻性收集奈梅亨拉德堡大学医学中心门诊接受生物制剂治疗的所有银屑病患者的登记数据进行分析。调查了患者和治疗特征。分析了依那西普长达3年的疗效和安全性。此外，研究了患者特征对依那西普治疗反应的影响。
分析的队列由118名患者组成，共经历了142个治疗疗程。接受生物制剂治疗的患者有广泛的病史。通过多种方式实现了生物治疗的优化，包括更换治疗药物和引入联合治疗。依那西普短期疗效分析显示，第24周时银屑病面积和严重程度指数（PASI）平均改善59.7%。尽管有趋势可循，但未发现性别、年龄、基线PASI、体重指数、既往全身治疗次数或银屑病病程对第24周疗效结果有显著影响。依那西普的疗效在长达156周内保持稳定。长期在日常实践中使用依那西普仅偶尔伴随重大安全问题。
当前研究表明，依那西普能够在相当长的时间内改善银屑病症状，且严重副作用不常见。患者特征对治疗反应的影响有限。
