Dattola Annunziata, Mazzeo Mauro, Di Stefano Flavia, Manfreda Valeria, Vollono Laura, Di Raimondo Cosimo, Di Matteo Eleonora, Bianchi Luca
Department of Dermatology, University of Rome "Tor Vergata", Rome, Italy.
Dermatol Ther. 2020 May;33(3):e13409. doi: 10.1111/dth.13409. Epub 2020 May 12.
We present the results on retrospective analysis about the efficacy of Certolizumab pegol (CZP), an antitumor necrosis factor-alpha agent, as monotherapy on skin psoriasis (PsO) in patients affect both by psoriatic arthritis (PsA) and mild-severe PsO. To date, the CZP is authorized for the treatment of PsA, PsO beyond that rheumatoid arthritis, axial spondyloarthritis/ankylosing spondylitis, and Crohn's. Assessments included an evaluation of the Psoriasis Area and Severity Index (PASI). Twelve patients (9M and 3F mean age 57.8 ± 8 years) were enrolled in our study. Nine patients had been previously treated with others biologic agents, three patients were naïve. Clinical and laboratory evaluations including PASI, erythrosedimentation rate, and C-reactive protein were performed at baseline (BL), at Week 12 (W12), Week 24 (W24), and Week 52 (W52) of treatment. Although the combination between methotrexate and CZP is allowed, we included, in our study, patients treated only with CZP. In such a way as to be as specific as possible, topical corticosteroids, vitamin D derivatives, retinoid creams, anthralin derivatives as well as p-UVA or UV-B have been forbidden to enrolled patients. With the same purpose, all the patients used the identical moisturizing cream two times a day. Mean PASI score decreased from 18 (BL) to 0 (W52) as follows: 18 at BL, 4 at W12, 0 at W24, and 0 at W52. Severe adverse events were not reported. Safety evaluations were performed every 3 months: liver and renal functions were monitored in all patients during the treatment, and no patient presented abnormal values. To the best of our knowledge, this is the first report that highlights the efficacy of CZP as monotherapy in psoriasis with mild to severe cutaneous involvement. Although to date the drug is authorized only for PsA, our results demonstrate that CZP is safe and effective on both cutaneous and joint components representing, therefore, an effective option in the treatment of cutaneous symptoms of PsO. Limitations of our study are presented by the relatively short observation time (W52) and by numeric small study group. Long-term data with a larger number of enrolled patients are necessary in order to confirm our preliminary observations.
我们展示了关于聚乙二醇化赛妥珠单抗（CZP）作为单药治疗对同时患有银屑病关节炎（PsA）和轻至重度寻常型银屑病（PsO）患者的寻常型银屑病（PsO）疗效的回顾性分析结果。迄今为止，CZP被批准用于治疗PsA、除类风湿关节炎之外的PsO、轴向性脊柱关节炎/强直性脊柱炎以及克罗恩病。评估包括银屑病面积和严重程度指数（PASI）的评估。12名患者（9名男性和3名女性，平均年龄57.8±8岁）纳入我们的研究。9名患者先前接受过其他生物制剂治疗，3名患者未曾接受过治疗。在治疗的基线期（BL）、第12周（W12）、第24周（W24）和第52周（W52）进行了包括PASI、红细胞沉降率和C反应蛋白在内的临床和实验室评估。尽管允许甲氨蝶呤与CZP联合使用，但在我们的研究中，纳入的患者仅接受CZP治疗。为了尽可能具体，已禁止入组患者使用外用糖皮质激素、维生素D衍生物、维甲酸乳膏、蒽林衍生物以及p - UVA或UV - B。出于同样目的，所有患者每天使用两次相同的保湿霜。PASI平均评分从18（BL）降至0（W52），具体如下：BL时为18，W12时为4，W24时为0，W52时为0。未报告严重不良事件。每3个月进行一次安全性评估：治疗期间对所有患者监测肝肾功能，无患者出现异常值。据我们所知，这是第一份强调CZP作为单药治疗对轻至重度皮肤受累银屑病疗效的报告。尽管迄今为止该药物仅被批准用于PsA，但我们的结果表明，CZP对皮肤和关节成分均安全有效，因此是治疗PsO皮肤症状的有效选择。我们研究的局限性在于观察时间相对较短（W52）以及研究组数量较少。为了证实我们的初步观察结果，需要有更多入组患者的长期数据。
