Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy.
J Dermatolog Treat. 2022 Mar;33(2):1074-1078. doi: 10.1080/09546634.2020.1800577. Epub 2020 Aug 4.
We aimed to evaluate the effectiveness, safety and tolerability of guselkumab in a real-life setting.
A prospective, observational, single-center, real-life study including patients under guselkumab treatment from October 2018 to January 2020 was conducted.
Twenty-three patients with moderate-to-severe psoriasis were enrolled and twenty-two continued the treatment until week 44. One patient discontinued for increase in liver enzymes. At baseline, mean PASI score was 15.1 ± 6.1, which reduced up to 3.2 ± 1.9 at week 12 ( < .001) and 0.8 ± 0.7 at week 44 ( < .001). BSA reduced from 36.4 ± 13.6 at baseline, to 8.3 ± 7.4 at week 12 ( < .001), up to 2.2 ± 1.4 at week 44 ( < .001). A total of 4 patients (17.4%) experienced mild blood tests alterations and 6 subjects (26%) experienced potential adverse events (AEs). No AEs required guselkumab discontinuation. No cases of serious AEs, injection site reaction, candida, malignancy, cardiovascular events were reported.
Patients under guselkumab therapy reach an optimal clinical response, even in a real-life and long-term setting.
评估古塞库单抗在真实环境中的疗效、安全性和耐受性。
开展了一项前瞻性、观察性、单中心、真实世界研究，纳入了 2018 年 10 月至 2020 年 1 月接受古塞库单抗治疗的患者。
共纳入 23 例中重度银屑病患者，22 例患者持续治疗至第 44 周。1 例患者因肝酶升高而停药。基线时，平均 PASI 评分为 15.1±6.1，治疗 12 周时降至 3.2±1.9（ < .001），44 周时降至 0.8±0.7（ < .001）。BSA 从基线时的 36.4±13.6 降至 12 周时的 8.3±7.4（ < .001），44 周时降至 2.2±1.4（ < .001）。共有 4 例（17.4%）患者出现轻度血液检查改变，6 例（26%）患者出现潜在不良事件（AE）。无 AE 需要停用古塞库单抗。未报告严重 AE、注射部位反应、念珠菌、恶性肿瘤、心血管事件。
即使在真实环境和长期治疗中，古塞库单抗治疗的患者也能达到最佳临床应答。
