Lunder Tomaz, Marko Pij, Koser Kolar Natasa, Kralj Boris, Kecelj Leskovec Nada
Department of Dermatovenereology, University Medical Centre Ljubljana, Zaloska cesta 2, 1000 Ljubljana, Slovenia; Medical Faculty, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.
Department of Dermatovenereology, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia.
Biologicals. 2018 Jul;54:44-49. doi: 10.1016/j.biologicals.2018.04.003. Epub 2018 Apr 26.
The study was designed as observational retrospective analysis of the data from Slovenian Registry of patients with moderate and severe psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab from 2005 to 2015. The survival rates of biologics were compared using survival analysis, and predictors of discontinuation were evaluated using a Cox regression model. All biologics have been prescribed as a first line therapy for moderate or severe psoriasis; 650 (94.9%) adalimumab, 254 (72.0%) ustekinumab, 76 (69.7%) infliximab, 68 (67.3%) etanercept. The overall biologics survival rate was 83.2% in the first line and 79.1% in the second line treatment. Drug survival for the first and second line of therapy was significantly longer for ustekinumab than for anti-TNFα agents (p < 0.001 and p = 0.014, respectively). Loss of efficacy accounted for 63% of all treatment discontinuations. Multivariate regression analysis showed that younger patients, being on etanercept, systemic conventional co-therapy, lower BSA and higher DLQI were independent predictors for treatment discontinuation. Our data showed the real-life situation in the treatment of moderate to severe psoriasis with biologics. Since longevity of drug survival is considered as a measure of treatment success, this data represents an important information when selecting a biologic treatment for individual patient.
该研究设计为对2005年至2015年期间在斯洛文尼亚接受阿达木单抗、依那西普、英夫利昔单抗或乌司奴单抗治疗的中度和重度银屑病患者登记数据进行观察性回顾分析。使用生存分析比较生物制剂的生存率，并使用Cox回归模型评估停药的预测因素。所有生物制剂均被指定为中度或重度银屑病的一线治疗药物；650例（94.9%）使用阿达木单抗，254例（72.0%）使用乌司奴单抗，76例（69.7%）使用英夫利昔单抗，68例（67.3%）使用依那西普。一线治疗中生物制剂的总体生存率为83.2%，二线治疗中为79.1%。乌司奴单抗一线和二线治疗的药物生存期明显长于抗TNFα药物（分别为p<0.001和p=0.014）。疗效丧失占所有治疗停药的63%。多变量回归分析显示，年轻患者、使用依那西普、全身传统联合治疗、较低的体表面积和较高的皮肤病生活质量指数是治疗停药的独立预测因素。我们的数据显示了生物制剂治疗中度至重度银屑病的实际情况。由于药物生存期被视为治疗成功的一项指标，因此该数据在为个体患者选择生物制剂治疗时具有重要参考价值。
