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司库奇尤单抗治疗银屑病的疗效和安全性:五年真实世界经验。

Efficacy and safety of secukinumab in psoriasis: five-year real life experience.

机构信息

Dermatology and Venereology Department, Eskisehir Osmangazi University, Eskisehir, Turkey.

Dermatology and Venereology Department, Eskisehir Osmangazi University, Eskisehir, Turkey.

出版信息

An Bras Dermatol. 2024 Nov-Dec;99(6):840-846. doi: 10.1016/j.abd.2023.12.004. Epub 2024 Jul 19.

Abstract

BACKGROUND

The efficacy and safety of secukinumab in psoriasis patients has been demonstrated in randomized controlled clinical trials.

OBJECTIVES

The authors aimed to evaluate the efficacy and safety of secukinumab in plaque psoriasis patients followed in our clinic.

METHODS

Data from 101 plaque psoriasis patients who received at least 16 weeks of secukinumab treatment between June 2018 and June 2023 were retrospectively analyzed.

RESULTS

Fifty-three (53%) of the patients were bionaive. PASI-75, -90, -100 response rates were 72%, 50%, 30% respectively at week 16 in all patients. PASI-75 and -90 responses were higher in naive patients at weeks 16 and 28 (p < 0.001, p < 0.001, p < 0.01, p = 0.01, respectively). The percentage of patients with PASI ≤ 1, ≤ 3, ≤ 5 were 50%, 77%, and 92%, respectively at week 16. They were higher in the naive group than in nonnaive group at weeks 16 and 28 (p = 0.02, p < 0.01, p = 0.05, p = 0.07, p < 0.01, p = 0.03, respectively). At week 52, PASI-75, -90, -100 responses were significantly lower in smoking patients (p = 0.04, p = 0.03, p < 0.01, respectively). The mean duration of secukinumab treatment was 19.80 ± 12.76 months. Secukinumab was discontinued 14 (26.4%) naive patients and 28 (58.3%) nonnaive patients at one occasion during treatment (p < 0.001). The most common adverse event in patients was mucocutaneous candida infection (8%). No hepatitis B or C reactivation and no active or reactivation tuberculosis were observed in any of the patients during the follow-up period.

STUDY LIMITATIONS

This is a single-center retrospective study with relatively few patients including only the Turkish population.

CONCLUSION

Secukinumab seems to be effective in plaque psoriasis, particularly in bionaive and non-smokers. Moreover, it is safe in patients with inactive hepatitis or tuberculosis.

摘要

背景

司库奇尤单抗在银屑病患者中的疗效和安全性已在随机对照临床试验中得到证实。

目的

作者旨在评估司库奇尤单抗在我们诊所接受治疗的斑块状银屑病患者中的疗效和安全性。

方法

回顾性分析了 2018 年 6 月至 2023 年 6 月期间接受至少 16 周司库奇尤单抗治疗的 101 例斑块状银屑病患者的数据。

结果

53%的患者为生物制剂初治患者。所有患者在第 16 周时的 PASI-75、-90 和-100 应答率分别为 72%、50%和 30%。初治患者在第 16 周和第 28 周时 PASI-75 和-90 的应答率更高(p<0.001、p<0.001、p<0.01、p=0.01、p<0.01)。第 16 周时,PASI≤1、≤3 和≤5 的患者比例分别为 50%、77%和 92%。在第 16 周和第 28 周时,初治组的这些比例均高于非初治组(p=0.02、p<0.01、p=0.05、p=0.07、p<0.01、p=0.03)。第 52 周时,吸烟患者的 PASI-75、-90 和-100 应答率显著降低(p=0.04、p=0.03、p<0.01)。司库奇尤单抗的平均治疗时间为 19.80±12.76 个月。在治疗期间,14 例(26.4%)初治患者和 28 例(58.3%)非初治患者因任何原因停止了治疗(p<0.001)。患者中最常见的不良事件是黏膜真菌感染(8%)。在整个随访期间,没有观察到乙型肝炎或丙型肝炎再激活或活动性或复发性结核病。

局限性

这是一项单中心回顾性研究,患者数量相对较少,仅包括土耳其人群。

结论

司库奇尤单抗在斑块状银屑病中似乎有效,尤其是在初治和非吸烟患者中。此外,它在患有静止性肝炎或结核病的患者中是安全的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c561/11551271/0a1dd2f8a53b/gr1.jpg

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