ABSTRACT

Introduction

Efficacy of anti-TNF-a agents seems inferior to IL-17 and IL-23 inhibitors. Nevertheless, after biosimilars approval, anti TNF-a agents are recommended as first-line for psoriatic patients, for economic reasons.

Methods

Predictive factors of response or non-response to adalimumab in bionaive patients who started adalimumab (originator or biosimilar) over 12 years in 9 dermatologic centers in Italy. Effectiveness was assessed with Psoriasis Area and Severity Index (PASI75 and PASI90) at weeks 12, 24 and 48. Multiple logistic regressions were used for variables predicting clinical response; Kaplan–Meier survival curves and Cox regression for drug survival.

Results

The drug survival analysis showed reduced hazard ratio of overall discontinuation with male gender and scalp localization. In contrast, baseline PASI and genital psoriasis were significantly associated with increased risk of overall discontinuation. Predictive factors of non-response seemed elevated in patients with baseline PASI, older age groups, previously treated patients with phototherapy, females or patients with palmo-plantar while scalp psoriasis, previous cyclosporine and acitretin appeared as a positive predictive factor.

Conclusions

This real-life analysis might be useful for clinicians in case of bio-naive patients with moderate-to-severe psoriasis and various comorbidities.

中文翻译：

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中重度银屑病初治患者对阿达木单抗缺乏反应的预测因素：意大利多中心数据收集分析

摘要

介绍

抗 TNF-α 药物的功效似乎不如 IL-17 和 IL-23 抑制剂。然而，在生物仿制药获批后，出于经济原因，抗 TNF-a 药物被推荐作为银屑病患者的一线药物。

方法

在意大利 9 个皮肤病学中心开始使用阿达木单抗（原研药或生物类似药）超过 12 年的生物初始患者对阿达木单抗有反应或无反应的预测因素。在第 12、24 和 48 周用银屑病面积和严重程度指数（PASI75 和 PASI90）评估有效性。多元逻辑回归用于预测临床反应的变量；药物存活的 Kaplan-Meier 存活曲线和 Cox 回归。

结果

药物生存分析显示，男性和头皮定位的总体停药风险比降低。相比之下，基线 PASI 和生殖器银屑病与总体停药风险增加显着相关。基线 PASI 患者、老年组、先前接受过光疗的患者、女性或掌跖患者的无应答预测因素似乎升高，而头皮银屑病、既往环孢素和阿维A 似乎是阳性预测因素。

结论

这种现实生活中的分析可能对临床医生有用，以应对患有中度至重度银屑病和各种合并症的生物初始患者。