Acosta-Felquer María Laura, Rosa Javier, Soriano Enrique R
Rheumatology Unit, Internal Medical Services, and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Open Access Rheumatol. 2016 Mar 30;8:37-44. doi: 10.2147/OARRR.S56837. eCollection 2016.
Certolizumab pegol (CZP) is a pegylated humanized tumor necrosis factor-α inhibitor (TNFi) approved for the treatment of psoriatic arthritis (PsA) in Europe, the USA, and Latin American countries. CZP neutralizes TNF-α at its soluble and membrane portions. Due to the lack of Fc region, it does not induce complement or antibody-dependent cytotoxicity in vitro, unlike other TNFi. RAPID-PsA study, the only randomized clinical trial performed in PsA, is a Phase III clinical trial conducted in 409 PsA patients during 24 weeks. Patients were randomized to CZP (200 mg every 2 weeks or 400 mg every 4 weeks) or placebo. Patients in CZP arms reported improvements in skin disease, joint involvement, dactylitis, enthesitis, and quality of life. Safety profile was similar to that reported for other TNF-α inhibitors in PsA patients. This article summarizes the pharmacology and reviews the efficacy and tolerability of this drug in PsA. CZP is the newest TNFi with proved efficacy in all manifestations of psoriasis disease, except for axial involvement where the evidence has been derived from response to axial spondyloarthritis.
赛妥珠单抗(CZP)是一种聚乙二醇化人源化肿瘤坏死因子-α抑制剂(TNFi),在欧洲、美国和拉丁美洲国家被批准用于治疗银屑病关节炎(PsA)。CZP可在可溶性和膜性部分中和肿瘤坏死因子-α。由于缺乏Fc区,与其他TNFi不同,它在体外不会诱导补体或抗体依赖性细胞毒性。RAPID-PsA研究是唯一一项在PsA患者中进行的随机临床试验,是一项在409例PsA患者中进行的为期24周的III期临床试验。患者被随机分为CZP组(每2周200mg或每4周400mg)或安慰剂组。CZP组患者报告皮肤疾病、关节受累、指(趾)炎、附着点炎和生活质量均有改善。安全性与PsA患者中其他肿瘤坏死因子-α抑制剂的报告相似。本文总结了该药物的药理学,并综述了其在PsA中的疗效和耐受性。CZP是最新的TNFi,已被证明对银屑病的所有表现均有效,但轴向受累方面的证据来自对轴向脊柱关节炎的反应。