Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, P. R. China.
Exp Dermatol. 2024 Jan;33(1):e14890. doi: 10.1111/exd.14890. Epub 2023 Jul 20.
A number of randomized controlled trials and real-world studies have demonstrated the effectiveness and safety of secukinumab in the treatment of moderate to severe psoriasis, whereas data on a large cohort of Chinese patients in long-term real-world practice are limited. This was a single-centre, uncontrolled, single-arm, prospective, observational cohort study that included 254 psoriatic patients treated with secukinumab between September 2019 and December 2022. Demographic and clinical characteristics of patients, clinical response and adverse events were evaluated. The 75% improvement in Psoriasis Area and Severity Index score (PASI 75), PASI 90, and PASI 100 in the 300 mg secukinumab group at 12 weeks were 91.7%, 74.0% and 39.7% respectively, increasing to 94.5%, 74.5% and 47.6% at 52 weeks. High body mass index (BMI), previous exposure to biologic therapies and history of previous conventional systemic therapies were associated with lower rates of PASI response. During the study period, 68 patients reported 83 adverse events (AEs) and the most frequent AEs were eczematous lesions. Up to 14.5% patients withdrew treatment due to disease remission combined with inconvenient transportation during the COVID-19 pandemic at 52 weeks. The rate of psoriasis exacerbation after COVID-19 infection in patients treated with secukinumab was 24.3% (17/70). This real-world study confirmed the high effectiveness of secukinumab in Chinese patients with moderate to severe plaque psoriasis, with an acceptable safety profile.
许多随机对照试验和真实世界研究已经证明司库奇尤单抗在治疗中重度银屑病中的有效性和安全性,而在长期真实世界实践中,关于大量中国患者的数据有限。这是一项单中心、非对照、单臂、前瞻性、观察性队列研究,纳入了 2019 年 9 月至 2022 年 12 月期间接受司库奇尤单抗治疗的 254 例银屑病患者。评估了患者的人口统计学和临床特征、临床反应和不良事件。在 12 周时,300mg 司库奇尤单抗组患者的银屑病面积和严重程度指数(PASI)评分改善 75%(PASI 75)、90%(PASI 90)和 100%(PASI 100)的比例分别为 91.7%、74.0%和 39.7%,在 52 周时增加至 94.5%、74.5%和 47.6%。较高的体重指数(BMI)、既往接受生物制剂治疗和既往常规系统治疗史与较低的 PASI 反应率相关。在研究期间,68 例患者报告了 83 例不良事件(AE),最常见的 AE 是湿疹样病变。在 52 周时,由于疾病缓解和 COVID-19 大流行期间交通不便,14.5%的患者停止治疗。接受司库奇尤单抗治疗的患者在 COVID-19 感染后银屑病恶化的发生率为 24.3%(17/70)。这项真实世界研究证实了司库奇尤单抗在中国中重度斑块状银屑病患者中的高疗效和可接受的安全性。