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阿普米司特治疗银屑病的应用:德尔菲研究。

The Use of Apremilast in Psoriasis: A Delphi Study.

机构信息

Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, España.

Servicio de Dermatología, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, España.

出版信息

Actas Dermosifiliogr (Engl Ed). 2020 Mar;111(2):115-134. doi: 10.1016/j.ad.2019.07.005. Epub 2019 Dec 19.

DOI:10.1016/j.ad.2019.07.005
PMID:31864537
Abstract

BACKGROUND

Experience in the use of apremilast in clinical practice complements the information available from pivotal clinical trials.

MATERIAL AND METHOD

Following a review of the literature, a panel of dermatologists with expertise in the management of psoriasis considered 5 scenarios in which the evidence supporting the use of apremilast to treat moderate psoriasis is insufficient or controversial. These scenarios were then assessed using a Delphi questionnaire.

RESULTS

Consensus was reached on 96 (67%) of the 143 items (positive in 85 and negative in 11). The therapeutic goal for apremilast should be based on 4 outcomes: clinical response, symptoms, quality of life, and patient satisfaction. The scenario in which the use of apremilast was considered to have the greatest possibility of success was in patients with stable moderate psoriasis. Most of the clinicians considered apremilast to be an appropriate treatment when conventional therapies fail or are contraindicated, preferably before the prescription of biologic therapy. Consensus was reached that apremilast is an appropriate treatment for psoriasis in difficult locations, such as the scalp or the palms and soles. It was also agreed that apremilast requires less prescreening and monitoring than other conventional and biologic systemic therapies.

CONCLUSIONS

Apremilast could be a treatment option for patients with a different profile to that of clinical trial participants. The limitations of this proposal are the absence of consensus on the definition of moderate psoriasis, the lack of real-world evidence on the use of apremilast, and certain aspects related to tolerability.

摘要

背景

在临床实践中使用阿普司特的经验补充了来自关键临床试验的可用信息。

材料和方法

在对文献进行回顾后,一组具有银屑病管理专业知识的皮肤科医生考虑了 5 种情况下使用阿普司特治疗中度银屑病的证据不足或存在争议的情况。然后使用德尔菲问卷调查对这些情况进行评估。

结果

在 143 项中的 96 项(阳性 85 项,阴性 11 项)达成了共识。阿普司特的治疗目标应基于 4 个结果:临床反应、症状、生活质量和患者满意度。阿普司特最有可能成功的情况是在稳定的中度银屑病患者中。大多数医生认为,当传统疗法失败或禁忌时,特别是在开生物治疗之前,阿普司特是一种合适的治疗方法。共识是,阿普司特是治疗头皮、手掌和足底等困难部位银屑病的一种合适治疗方法。也一致认为,与其他传统和生物系统性疗法相比,阿普司特需要较少的预筛查和监测。

结论

阿普司特可能是一种治疗方案,适用于与临床试验参与者不同特征的患者。该建议的局限性在于缺乏对中度银屑病定义的共识、缺乏阿普司特使用的真实世界证据以及与耐受性相关的某些方面。

相似文献

1
The Use of Apremilast in Psoriasis: A Delphi Study.阿普米司特治疗银屑病的应用:德尔菲研究。
Actas Dermosifiliogr (Engl Ed). 2020 Mar;111(2):115-134. doi: 10.1016/j.ad.2019.07.005. Epub 2019 Dec 19.
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Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis.阿普米司特,一种口服磷酸二酯酶-4 抑制剂,治疗掌跖银屑病:来自 PSOR-005 Ⅱ期和 Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis(ESTEEM)Ⅲ期临床试验的汇总分析结果,该试验入组了中重度银屑病患者。
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Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.阿普米司特治疗中重度头皮斑块状银屑病的疗效和安全性:一项 3b 期、多中心、随机、安慰剂对照、双盲研究的结果。
J Am Acad Dermatol. 2020 Jul;83(1):96-103. doi: 10.1016/j.jaad.2020.01.072. Epub 2020 Feb 4.
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Apremilast: A Review in Psoriasis and Psoriatic Arthritis.阿普米司特:用于银屑病和银屑病关节炎的治疗。
Drugs. 2017 Mar;77(4):459-472. doi: 10.1007/s40265-017-0709-1.
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▼ Apremilast for psoriasis and psoriatic arthritis.▼ 阿普斯特用于治疗银屑病和银屑病关节炎。
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Off-label studies on apremilast in dermatology: a review.阿普斯特在皮肤科的超适应证研究:综述。
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The Use of Apremilast in Psoriasis: An Indian Perspective on Real-World Scenarios.阿普米拉斯在银屑病治疗中的应用:印度对现实世界情况的看法。
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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。
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New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast.银屑病和银屑病关节炎管理的新进展:聚焦阿普斯特
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引用本文的文献

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Moderate Psoriasis in Clinical Practice: French Expert Consensus Using a Modified Delphi Method.《临床中中度银屑病的治疗:使用改良 Delphi 法的法国专家共识》。
Adv Ther. 2022 Nov;39(11):5203-5215. doi: 10.1007/s12325-022-02305-z. Epub 2022 Sep 16.
2
An Open-Label, Randomized, Prospective, Comparative, Three-Arm Clinical Trial to Evaluate the Safety and Effectiveness of Apremilast with Three Different Titration Methods in Patients with Chronic Plaque Psoriasis in India.一项开放标签、随机、前瞻性、比较性、三臂临床试验,以评估阿普米拉斯三种不同滴定方法在印度慢性斑块状银屑病患者中的安全性和有效性。
Psoriasis (Auckl). 2022 Apr 22;12:53-61. doi: 10.2147/PTT.S357184. eCollection 2022.
3
The Use of Apremilast in Psoriasis: An Indian Perspective on Real-World Scenarios.
阿普米拉斯在银屑病治疗中的应用:印度对现实世界情况的看法。
Psoriasis (Auckl). 2021 Aug 14;11:109-122. doi: 10.2147/PTT.S320810. eCollection 2021.