Di Lernia Vito, Macca Laura, Peterle Lucia, Ingrasciotta Ylenia, Trifirò Gianluca, Guarneri Claudio
Dermatology Unit, Arcispedale S. Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Department of Clinical and Experimental Medicine, Section of Dermatology, University of Messina, Messina, Italy.
Front Pharmacol. 2022 Apr 5;13:847308. doi: 10.3389/fphar.2022.847308. eCollection 2022.
Psoriasis is a chronic, immune-mediated skin disease that may occur at any age. Prevalence in children ranges between 0.5 and 1.0% across Europe. Approximately 10-20% of paediatric psoriasis patients are moderate-to-severe in severity and may require the use of systemic therapy. Recently, newer targeted, systemic therapies have been licensed for treatment of moderate-to-severe paediatric psoriasis. The objective of this study was to evaluate the short-term efficacy of available antipsoriatic systemic drugs in children with a narrative synthesis of key efficacy from randomized clinical trials. A systematic review of literature was performed on Medline and embase databases and the Cochrane Central Register of Controlled Trials. Randomized clinical trials investigating the efficacy of treatments licensed by the US Food and Drug Administration and/or the European Medicines Agency for paediatric and adolescent psoriatic population were retrieved and analyzed. Data from this literature review was assessed in line with GRADE (grading of recommendations, assessment, development and evaluations). The short-term (12-16 weeks) clinical efficacy from baseline was evaluated according to the Psoriasis Area and Severity Index (PASI) 75 and 90 compared to baseline. Illustrative comparative risks, relative risk (RR) and the number needed to treat (NNT) for response on PASI 75 and PASI 90 were extracted. A total of five relevant studies were identified on two TNF-alpha blockers (etanercept and adalimumab), the IL12/23 inhibitor ustekinumab and two IL-17 inhibitors (ixekizumab, secukinumab). Comparators were placebo (3 studies), placebo and etanercept (1 study) methotrexate (1 study). All examined drugs resulted efficacious. The probability to achieve PASI 75 and PASI 90 was higher for the IL-12/23 and IL-17 inhibitors. Overall, the anti-IL17s and the anti-IL12/23 antibodies showed a more favourable NNT for PASI 75, whereas IL-17 inhibitors for PASI 90. The approved biological therapies may be beneficial for the treatment of moderate to severe plaque psoriasis in children and adolescents. Since psoriasis is a chronic and often challenging condition with no definitive solution, systematic evaluations of long-term efficacy, drug survival and adverse effects may help careful, individualized, patient-centered clinical decision making.
银屑病是一种慢性、免疫介导的皮肤病，可发生于任何年龄。在欧洲，儿童银屑病的患病率在0.5%至1.0%之间。约10%-20%的儿童银屑病患者病情为中度至重度，可能需要使用全身治疗。最近，新型靶向全身治疗药物已获批用于治疗中度至重度儿童银屑病。本研究的目的是通过对随机临床试验的关键疗效进行叙述性综合分析，评估现有抗银屑病全身药物在儿童中的短期疗效。对Medline、Embase数据库以及Cochrane对照试验中心注册库进行了文献系统综述。检索并分析了调查美国食品药品监督管理局和/或欧洲药品管理局批准用于儿童和青少年银屑病患者治疗药物疗效的随机临床试验。根据GRADE（推荐分级、评估、制定和评价）对该文献综述的数据进行评估。与基线相比，根据银屑病面积和严重程度指数（PASI）75和90评估从基线开始的短期（12-16周）临床疗效。提取了PASI 75和PASI 90反应的示例性比较风险、相对风险（RR）和治疗所需人数（NNT）。共确定了五项关于两种肿瘤坏死因子-α阻滞剂（依那西普和阿达木单抗）、白细胞介素12/23抑制剂乌司奴单抗和两种白细胞介素-17抑制剂（司库奇尤单抗、依奇珠单抗）的相关研究。对照为安慰剂（3项研究）、安慰剂和依那西普（1项研究）、甲氨蝶呤（1项研究）。所有研究的药物均显示有效。白细胞介素-12/23和白细胞介素-17抑制剂达到PASI 75和PASI 90的概率更高。总体而言，抗白细胞介素-17药物和抗白细胞介素-12/23抗体对PASI 75显示出更有利的NNT，而白细胞介素-17抑制剂对PASI 90显示出更有利的NNT。获批的生物治疗可能对儿童和青少年中度至重度斑块状银屑病的治疗有益。由于银屑病是一种慢性且往往具有挑战性的疾病，尚无确切解决方案，对长期疗效、药物生存期和不良反应进行系统评估可能有助于做出谨慎、个性化、以患者为中心的临床决策。
