Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Department of Dermatology, University of Rome 'Tor Vergata', Rome, Italy.
Dermatol Ther. 2019 Nov;32(6):e13091. doi: 10.1111/dth.13091. Epub 2019 Oct 28.
The objective of this study is to determine drug effectiveness and safety of the tumor necrosis factor-alpha blocker monoclonal antibody adalimumab in a real-life cohort of 54 children and/or adolescents with severe plaque psoriasis. Retrospective, multicenter analysis over a 52-week period is discussed in this study. Efficacy was determined by the percentage of patients achieving Psoriasis Area Severity Index (PASI 75) and PASI 90 at weeks 16, 24, and 52 and the response in biologic-naïve versus non-naïve patients. Safety was assessed by the number of patients experiencing at least one adverse event. At week 16, 29.6% of patients achieved a 90% PASI score reduction (PASI 90), while 55.5% of patients achieved a 75% PASI score reduction (PASI 75). Effectiveness was sustained through week 24, since PASI 90 response increased to 55.5% and PASI 75 response increased to 74.0% of patients. The PASI response rates did not differ between biologic-naïve and non-naïve patients. The drug was well tolerated and no serious infections were observed. Adalimumab was effective and safe in this cohort of children with severe plaque psoriasis in a 52-week observation. Effectiveness did not differ between biologic-naïve and non-naïve patients.
本研究旨在确定肿瘤坏死因子-α 阻断单克隆抗体阿达木单抗在 54 名严重斑块状银屑病儿童和/或青少年真实队列中的药物疗效和安全性。本研究讨论了为期 52 周的回顾性多中心分析。通过第 16、24 和 52 周时达到银屑病面积严重程度指数（PASI 75）和 PASI 90 的患者百分比以及生物初治与非初治患者的反应来确定疗效。通过至少发生一次不良事件的患者人数来评估安全性。第 16 周时，29.6%的患者达到了 90%的 PASI 评分降低（PASI 90），而 55.5%的患者达到了 75%的 PASI 评分降低（PASI 75）。通过第 24 周，有效性得以维持，因为 PASI 90 的应答率增加到 55.5%，PASI 75 的应答率增加到 74.0%的患者。生物初治与非初治患者的 PASI 应答率没有差异。该药物耐受性良好，未观察到严重感染。阿达木单抗在 52 周观察期间对严重斑块状银屑病患儿的疗效和安全性良好。生物初治与非初治患者的疗效无差异。
