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用于治疗银屑病的阿普米司特是否如临床试验所报告的那样有效且安全?来自希腊一家三级医院的五年经验:阿普米司特在希腊的长期真实世界疗效和安全性。

Is apremilast for psoriasis as effective and safe as reported in clinical trials? Five-year experience from a Greek tertiary hospital: long-term real-life efficacy and safety of apremilast in Greece.

机构信息

First Department of Dermatology and Venereology, School of Medicine, Aristotle University, Thessaloniki, Greece.

出版信息

Clin Exp Dermatol. 2021 Dec;46(8):1542-1544. doi: 10.1111/ced.14665. Epub 2021 May 11.

DOI:10.1111/ced.14665
PMID:33811368
Abstract

Apremilast has been approved as an effective and safe treatment for psoriasis, but clinical trial results may differ from real-life data. This retrospective cross-sectional study evaluated the long-term efficacy and safety of apremilast in a Greek cohort of adult patients with psoriasis who had received at least one dose of apremilast between March 2016 and January 2021. The primary endpoint was the percentage of patients who achieved 75% reduction in Psoriasis Area Severity Index (PASI75) at Week 16. Absolute PASI, PASI90 (90% reduction) and adverse events were also recorded at various timepoints. In total, 102 patients (29.4% women, 70.6% men) with a mean ± SD age 55.94 ± 15.21 years were included. PASI75 and PASI90 were achieved by 20.8% and 1.98% of patients, respectively, at Week 16. According to our results, PASI90 achievement was significantly lower than that reported in clinical trials. The efficacy of apremilast increased gradually until Week 24, with further improvement noted in good responders up to Week 52.

摘要

阿普司特已被批准为治疗银屑病的有效且安全的药物,但临床试验结果可能与真实世界的数据有所不同。本回顾性横断面研究评估了阿普司特在希腊成年银屑病患者队列中的长期疗效和安全性,这些患者在 2016 年 3 月至 2021 年 1 月期间至少接受过一次阿普司特治疗。主要终点是第 16 周时达到银屑病面积严重程度指数(PASI75)改善 75%的患者比例。还记录了在不同时间点的绝对 PASI、PASI90(90%改善)和不良反应。共纳入 102 例患者(29.4%女性,70.6%男性),平均年龄为 55.94±15.21 岁。第 16 周时,分别有 20.8%和 1.98%的患者达到 PASI75 和 PASI90。根据我们的结果,PASI90 的达标率显著低于临床试验报道的水平。阿普司特的疗效逐渐增加,直到第 24 周,在治疗反应良好的患者中,直至第 52 周时仍有进一步改善。

相似文献

1
Is apremilast for psoriasis as effective and safe as reported in clinical trials? Five-year experience from a Greek tertiary hospital: long-term real-life efficacy and safety of apremilast in Greece.用于治疗银屑病的阿普米司特是否如临床试验所报告的那样有效且安全?来自希腊一家三级医院的五年经验:阿普米司特在希腊的长期真实世界疗效和安全性。
Clin Exp Dermatol. 2021 Dec;46(8):1542-1544. doi: 10.1111/ced.14665. Epub 2021 May 11.
2
Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study.在 LIBERATE 研究中,接受阿普司特治疗或从依那西普治疗转换的中重度斑块状银屑病患者中,阿普司特治疗 104 周的安全性和疗效。
J Eur Acad Dermatol Venereol. 2018 Mar;32(3):397-402. doi: 10.1111/jdv.14738. Epub 2018 Jan 29.
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Efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis: a phase II open-label study.阿普司特治疗顽固性斑块状银屑病的疗效、耐受性及药效学:一项II期开放标签研究。
J Drugs Dermatol. 2013 Aug;12(8):888-97.
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Apremilast in psoriasis - a prospective real-world study.阿普米司特治疗银屑病-一项前瞻性真实世界研究。
J Eur Acad Dermatol Venereol. 2018 Feb;32(2):254-259. doi: 10.1111/jdv.14598. Epub 2017 Oct 12.
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The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).阿普米拉斯、依那西普和安慰剂治疗中重度斑块状银屑病患者的疗效和安全性:一项IIIb期随机安慰剂对照试验(LIBERATE)的52周结果
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Real-world use of apremilast for patients with psoriasis in Japan.日本银屑病患者阿普米司特的真实世界应用。
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Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial.阿普司特,一种口服磷酸二酯酶4抑制剂,用于治疗日本中重度斑块状银屑病患者:2b期随机对照试验的疗效、安全性和耐受性结果
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Real-World Effectiveness and Safety of Apremilast in Older Patients with Psoriasis.阿普米司特治疗老年银屑病患者的真实世界疗效和安全性。
Drugs Aging. 2020 Sep;37(9):657-663. doi: 10.1007/s40266-020-00781-y.
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Real-world data on the efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis.阿普米司特治疗中重度斑块型银屑病的真实世界疗效和安全性数据。
J Eur Acad Dermatol Venereol. 2018 Jul;32(7):1173-1179. doi: 10.1111/jdv.14832. Epub 2018 Mar 30.
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Real-world data on the efficacy and safety of apremilast in Japanese patients with plaque psoriasis.真实世界中阿普米司特治疗日本斑块状银屑病患者的疗效和安全性数据。
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