Rheumatology Unit, Department of Biotechnological and Applied Clinical Science, School of Medicine, University of L'Aquila, L'Aquila, Italy.
Department of Medicine, ASL1 Avezzano-Sulmona-L'Aquila, L'Aquila, Italy.
J Dermatolog Treat. 2020 Nov;31(7):692-697. doi: 10.1080/09546634.2019.1605143. Epub 2019 May 6.
The aim of this observational study was to assess safety and efficacy of certolizumab pegol (CZP) in a real-life cohort of patients affected by psoriasis (PsO) and psoriatic arthritis (PsA), who had an inadequate response to previous systemic immunosuppressive treatments, with a follow-up of 24 weeks. Twelve patients with PsO and PsA, referring to our Dermatology/Rheumatology combined outpatient clinic, were enrolled. Primary endpoints were safety and efficacy of CZP, defined as statistically significant improvement of DAPSA, clinical DAPSA and PASI. Secondary endpoints validated clinical and laboratory measures and patient-reported outcomes. CZP injections were well-tolerated. We observed a rapid and significant improvement in all primary endpoints, in the 24-week treatment period of the study. We described positive effects of CZP in several domains, including joint and skin involvement, pain, patient and physician global assessment, physical function, and health-related quality of life. CZP was effective and safe in patients who were either naïve or previously unresponsive to other anti-TNFα. No difference was found in terms of efficacy and safety between patients treated with CZP monotherapy and patients in combination therapy with methotrexate. CZP was safe and effective in a real-life cohort of patients affected by PsO and PsA, who have had an inadequate response to previous systemic treatments.
本观察性研究的目的是评估培塞利珠单抗(CZP)在既往接受系统性免疫抑制治疗疗效欠佳的银屑病(PsO)和银屑病关节炎(PsA)患者中的安全性和疗效,随访 24 周。12 名患有 PsO 和 PsA 的患者在我们的皮肤科/风湿病联合门诊就诊,被纳入研究。主要终点是 CZP 的安全性和疗效,定义为 DAPSA、临床 DAPSA 和 PASI 有统计学意义的改善。次要终点验证了临床和实验室指标以及患者报告的结果。CZP 注射耐受良好。我们观察到在研究的 24 周治疗期间,所有主要终点均迅速显著改善。我们描述了 CZP 在多个领域的积极作用,包括关节和皮肤受累、疼痛、患者和医生整体评估、身体功能和健康相关生活质量。CZP 对既往未接受过其他抗 TNF-α 治疗或对其他抗 TNF-α 治疗无应答的患者均有效且安全。在接受 CZP 单药治疗的患者和接受 CZP 联合甲氨蝶呤治疗的患者之间,疗效和安全性无差异。CZP 在既往接受系统性治疗疗效欠佳的 PsO 和 PsA 患者中是安全且有效的。