Caldarola Giacomo, Chiricozzi A, Megna M, Dapavo P, Giunta A, Burlando M, Malagoli P, Dini V, Mariani M, Fabbrocini G, Quaglino P, Bianchi L, Parodi A, Peris K, De Simone C
Section of Dermatology, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
Dermatology Unit, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Expert Opin Biol Ther. 2023 Apr;23(4):365-370. doi: 10.1080/14712598.2023.2193288. Epub 2023 Mar 20.
Confirmatory data on the long-term effectiveness and safety of ixekizumab in psoriatic patients from real-world studies are needed.
The primary aim was to evaluate the 3-year drug survival of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis, in a multicenter real-world setting. The secondary aim was to assess the influence of predictive factors on the drug survival of ixekizumab.
A retrospective analysis was performed on a cohort of patients with chronic plaque psoriasis, who received at least one dose of ixekizumab before December 2018. The drug survival analysis was performed and descriptively analyzed using Kaplan-Meier survival curves. Multivariable Cox regression analyses were carried out including variables considered to be of clinical importance.
A total of 306 patients were enrolled. The overall drug survival at 12, 24, and 36 months of treatment with ixekizumab was 92.11%, 83.85%, and 80.19%, respectively. A higher probability (HR 2.34) of drug withdrawal was found among patients who had already received an anti-IL-17 agent compared with bio-naive patients (p 0.017).
We found that ixekizumab is a biological agent characterized by long-term effectiveness, not influenced by several clinical factors and associated with a good safety profile.
需要来自真实世界研究的关于司库奇尤单抗在银屑病患者中长期有效性和安全性的确证性数据。
主要目的是在多中心真实世界环境中评估司库奇尤单抗治疗中度至重度斑块状银屑病患者的3年药物留存率。次要目的是评估预测因素对司库奇尤单抗药物留存率的影响。
对一组慢性斑块状银屑病患者进行回顾性分析，这些患者在2018年12月之前至少接受过一剂司库奇尤单抗。使用Kaplan-Meier生存曲线进行药物留存率分析并进行描述性分析。进行多变量Cox回归分析，纳入被认为具有临床重要性的变量。
共纳入306例患者。司库奇尤单抗治疗12、24和36个月时的总体药物留存率分别为92.11%、83.85%和80.19%。与未使用过生物制剂的患者相比，已接受抗IL-17药物治疗的患者停药概率更高（风险比2.34）（p = 0.017）。
我们发现司库奇尤单抗是一种具有长期有效性的生物制剂，不受多种临床因素影响，且安全性良好。
