Dattola A, Balato A, Megna M, Gisondi P, Girolomoni G, De Simone C, Caldarola G, Cama E, Piaserico S, Fargnoli M C, Fidanza R, Parodi A, Burlando M, Offidani A, Diotallevi F, Potenza C, Conti A, Chiricozzi A, Campione E, Bianchi L
Department of Dermatology, University of Rome, "Tor Vergata", Rome, Italy.
Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
J Eur Acad Dermatol Venereol. 2020 Dec;34(12):2839-2845. doi: 10.1111/jdv.16606. Epub 2020 Jun 26.
Certolizumab, a pegylated tumour necrosis factor-α inhibitor, reduced disease activity in randomized trials of patients with psoriasis and psoriatic arthritis. Real-life data are missing.
To confirm the effectiveness and safety of certolizumab in patients with psoriasis and psoriatic arthritis in routine clinical practice.
In this retrospective study involving 11 Italian sites, patients with psoriasis and psoriatic arthritis received subcutaneous certolizumab (400 mg loading dose at 0, 2 and 4 weeks, followed by 200 mg every 2 weeks) for up to 52 weeks. Primary outcomes included mean change from baseline in Psoriasis Area and Severity Index (PASI) and modified Nail Psoriasis Severity Index (mNAPSI) scores, and the proportion of patients achieving a 75%, 90% or 100% reduction in PASI score. Other endpoints included Disease Activity Score computed on 44 joints correlated with the erythrocyte sedimentation rate during the first hour (DAS44-ESR), Tender Joint Count (TJC), Swollen Joint Count (SJC), pain [visual analogue scale (VAS) score], inflammatory markers and quality of life (QOL).
In the study were enrolled 153 patients (mean age: 55 years). Certolizumab reduced the mean PASI score from baseline by 4.45, 6.30 and 7.58 at weeks 12, 24 and 52, respectively (P < 0.001 for all). At weeks 24 and 52, 69.6% and 83.3% of patients had a PASI score ≤3. DAS44-ESR, TJC, SJC and mNAPSI scores, and pain VAS were also all significantly improved from baseline at each time point. C-reactive protein levels decreased during treatment, being significant at week 24. On multivariate analysis, psoriasis duration, baseline PASI, mNAPSI and pain VAS scores were found to be predictive of the improvement in PASI score at week 12.
Certolizumab displayed also in the real-life encouraging results in both psoriasis and psoriatic arthritis patients.
赛妥珠单抗是一种聚乙二醇化肿瘤坏死因子-α抑制剂，在银屑病和银屑病关节炎患者的随机试验中可降低疾病活动度。目前缺乏实际应用数据。
在常规临床实践中证实赛妥珠单抗治疗银屑病和银屑病关节炎患者的有效性和安全性。
在这项涉及11个意大利研究点的回顾性研究中，银屑病和银屑病关节炎患者接受皮下注射赛妥珠单抗（0、2和4周时给予400mg负荷剂量，随后每2周给予200mg），治疗长达52周。主要结局包括银屑病面积和严重程度指数（PASI）及改良甲银屑病严重程度指数（mNAPSI）评分相对于基线的平均变化，以及PASI评分降低75%、90%或100%的患者比例。其他终点包括根据44个关节计算的疾病活动评分与第1小时红细胞沉降率相关（DAS44-ESR）、压痛关节计数（TJC）、肿胀关节计数（SJC）、疼痛[视觉模拟量表（VAS）评分]、炎症标志物和生活质量（QOL）。
共纳入153例患者（平均年龄：55岁）。赛妥珠单抗在第12、24和52周时分别使PASI评分相对于基线的平均值降低4.45、6.30和7.58（所有P均<0.001）。在第24和52周时，分别有69.6%和83.3%的患者PASI评分≤3。DAS44-ESR、TJC、SJC和mNAPSI评分以及疼痛VAS在每个时间点相对于基线也均有显著改善。治疗期间C反应蛋白水平下降，在第24周时有显著意义。多因素分析显示，银屑病病程、基线PASI、mNAPSI和疼痛VAS评分可预测第12周时PASI评分的改善情况。
赛妥珠单抗在银屑病和银屑病关节炎患者的实际应用中也显示出令人鼓舞的结果。
