Department of Dermatology, Hospital Universitario San Cecilio, Granada, Spain.
Department of Dermatology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
Dermatol Ther. 2021 Mar;34(2):e14798. doi: 10.1111/dth.14798. Epub 2021 Feb 7.
Guselkumab is a fully human immunoglobulin-G1-lambda (IgG1λ) monoclonal antibody that binds selectively to the p19 subunit of interleukin 23. Few series of real clinical practice that reflect the use of guselkumab have been published so far, including the measure of survival at more than 52 weeks. An observational, longitudinal, retrospective study of real clinical practice of patients with moderate to severe psoriasis receiving treatment with guselkumab 100 mg subcutaneous every 8 weeks in five tertiary hospitals in Andalusia (Spain) was carried out. A total of 87 patients were included in this study. Disease severity and treatment response was assessed by PASI, BSA, VAS pruritus, and DLQI at baseline and after 4, 12, 24, 36, 52, and 76 weeks. Data are presented as mean ± SD for continuous variables, and number and percentage for categorical variables. To determine the differences between visits in PASI, BSA, VAS pruritus, and DLQI a Wilcoxon matched-pairs test was performed. The survival of guselkumab was calculated using Kaplan-Meier survival analysis. Our population presented with a mean age of 49.9 years, 60.9% of them were male, had a mean PSO evolution of 20.4 (9.5) years. A total of 79.3% were obese or presented with overweight and had several comorbidities (dyslipidemia 28.7%, arterial hypertension 23% and 20% diabetes among others). At baseline their disease parameters were: PASI = 14.6 (7.2), BSA = 22.3 (16.6), VAS pruritus = 6.0 (2), and DLQI = 15.8 (5). After 52 weeks their disease improved to PASI = 0.9 (1.1), BSA = 1.0 (1.8), VAS pruritus = 0.47 (0.88), and DLQI = 1.54 (2.50). The percentage of patients who achieved PASI 75, 90, and 100 at 52 weeks was 90.3%, 71%, and 51.6%, respectively. The patients evaluated at week 76 (n = 3) reached PASI 0, BSA 0, and DLQI 0. After 93.4 weeks (1 year, 9 months, and 14 days), the overall survival rate was 94% (4 events were reported). A total of four patients discontinue to AE or lack of efficacy after 76 weeks. Guselkumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 to 76 weeks and a good safety profile.
古塞库单抗是一种完全人源化 IgG1λ 单克隆抗体，能选择性地与白细胞介素 23 的 p19 亚基结合。到目前为止，已经发表了一些反映古塞库单抗实际临床应用的系列研究，包括 52 周以上的生存测量。在安达卢西亚（西班牙）的五所三级医院中，对接受古塞库单抗 100mg 皮下注射每 8 周治疗的中度至重度银屑病患者进行了一项观察性、纵向、回顾性的真实临床实践研究。本研究共纳入 87 例患者。在基线和第 4、12、24、36、52 和 76 周时，通过 PASI、BSA、瘙痒 VAS 和 DLQI 评估疾病严重程度和治疗反应。数据以连续变量的均数±标准差表示，分类变量以例数和百分比表示。为了确定 PASI、BSA、瘙痒 VAS 和 DLQI 各访视点之间的差异，进行了 Wilcoxon 配对样本检验。采用 Kaplan-Meier 生存分析法计算古塞库单抗的生存率。我们的研究人群平均年龄为 49.9 岁，其中 60.9%为男性，平均 PSO 病程为 20.4（9.5）年。共有 79.3%的患者肥胖或超重，且患有多种合并症（28.7%的血脂异常、23%的动脉高血压和 20%的糖尿病等）。基线时他们的疾病参数为：PASI=14.6（7.2），BSA=22.3（16.6），瘙痒 VAS=6.0（2），DLQI=15.8（5）。52 周后，他们的疾病改善到 PASI=0.9（1.1），BSA=1.0（1.8），瘙痒 VAS=0.47（0.88），DLQI=1.54（2.50）。52 周时达到 PASI75%、90%和 100%的患者比例分别为 90.3%、71%和 51.6%。在第 76 周评估的 3 名患者（n=3）达到 PASI0、BSA0 和 DLQI0。93.4 周（1 年 9 个月 14 天）后，总体生存率为 94%（报告了 4 例事件）。4 例患者在 76 周后因 AE 或疗效不佳而停药。古塞库单抗在中期对银屑病的控制效果非常好，在 52 至 76 周后，有更多的患者维持治疗，且安全性良好。
