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150毫克与300毫克司库奇尤单抗治疗中度至重度斑块状银屑病的药物不良事件:一项系统评价和荟萃分析。

Adverse drug events observed with 150 mg versus 300 mg secukinumab for the treatment of moderate to severe plaque psoriasis: A systematic review and meta-analysis.

作者信息

Zhang Li, Yang Hua, Chen Qihong, Zhao Jing

机构信息

Department of Dermatology.

Department of Cardiology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, China.

出版信息

Medicine (Baltimore). 2019 Jan;98(2):e14042. doi: 10.1097/MD.0000000000014042.

DOI:10.1097/MD.0000000000014042
PMID:30633199
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6336633/
Abstract

BACKGROUND

Secukinumab has been approved for the treatment of moderate to severe plaque psoriasis. However, safety measures concerning drug administration is vital during treatment. Understanding the right way to administer drugs is important to reduce any serious adverse drug event. In this analysis we aimed to systematically show the risk of adverse drug events which were observed with 150 mg versus (vs) 300 mg secukinumab for the treatment of moderate to severe plaque psoriasis.

METHODS

The major online databases: Cochrane Central, MEDLINE, www.ClinicalTrials.com and EMBASE were searched for relevant publications based on the comparison of secukinumab 150 mg vs 300 mg for the treatment of moderate to severe plaque psoriasis. Adverse drug events were considered as the clinical endpoints. Statistical analysis was carried out by the RevMan 5.3 software. Risk ratios (RR) and 95% confidence intervals (CIs) were generated to represent the data following statistical analysis.

RESULTS

Seven studies with a total number of 2361 participants were included. Results of this analysis showed that the risk of any adverse event (RR: 1.00, 95% CI: 0.96-1.05; P = .94), the risk of serious adverse events (RR: 1.04, 95% CI: 0.75-1.43; P = .82) and the risk of adverse events leading to drug discontinuation (RR: 0.98, 95% CI: 0.61-1.57; P = .92) were not significantly different between 150 mg vs 300 mg secukinumab for the treatment of moderate to severe plaque psoriasis. When the detailed adverse drug events were studied, the risks of infection or infestation (RR: 1.11, 95% CI: 0.98-1.25; P = .09), naso-pharyngitis (RR: 1.05, 95% CI: 0.90-1.23; P = .55), headache (RR: 0.92, 95% CI: 0.68-1.25; P = .60), diarrhea (RR: 1.14, 95% CI: 0.75-1.73; P = .55), pruritus (RR: 0.82, 95% CI: 0.56-1.22; P = .33), arthralgia (RR: 0.96, 95% CI: 0.67-1.38; P = .83), upper respiratory tract infection (RR: 0.98, 95% CI: 0.70-1.36; P = .89), hypertension (RR: 1.22, 95% CI: 0.83-1.81; P = .31), nausea (RR: 1.39, 95% CI: 0.63-3.04; P = .42), and cough (RR: 1.46, 95% CI: 0.67-3.19; P = .34) were still not significantly different between these 2 dosage regimens.

CONCLUSION

Secukinumab 150 mg and 300 mg were both equally tolerable and might safely be used for the treatment of moderate to severe plaque psoriasis. No significant adverse drug events were observed with any of the dosage.

摘要

背景

司库奇尤单抗已被批准用于治疗中度至重度斑块状银屑病。然而,治疗期间药物给药的安全措施至关重要。了解正确的给药方式对于减少任何严重的药物不良事件很重要。在本分析中,我们旨在系统地展示在治疗中度至重度斑块状银屑病时,150mg与300mg司库奇尤单抗相比所观察到的药物不良事件风险。

方法

基于150mg与300mg司库奇尤单抗治疗中度至重度斑块状银屑病的比较,在主要在线数据库:Cochrane Central、MEDLINE、www.ClinicalTrials.com和EMBASE中检索相关出版物。药物不良事件被视为临床终点。使用RevMan 5.3软件进行统计分析。统计分析后生成风险比(RR)和95%置信区间(CI)来表示数据。

结果

纳入了7项研究,共有2361名参与者。该分析结果表明,在治疗中度至重度斑块状银屑病时,150mg与300mg司库奇尤单抗相比,任何不良事件的风险(RR:1.00,95%CI:0.96 - 1.05;P = 0.94)、严重不良事件的风险(RR:1.04,95%CI:0.75 - 1.43;P = 0.82)以及导致停药的不良事件风险(RR:0.98,95%CI:0.61 - 1.57;P = 0.92)均无显著差异。当研究详细的药物不良事件时,感染或寄生虫感染的风险(RR:1.11,95%CI:0.98 - 1.25;P = 0.09)、鼻咽炎的风险(RR:1.05,95%CI:0.90 - 1.23;P = 0.55)、头痛的风险(RR:0.92,95%CI:0.68 - 1.25;P = 0.60)、腹泻的风险(RR:1.14,95%CI:0.75 - 1.73;P = 0.55)、瘙痒的风险(RR:0.82,95%CI:0.56 - 1.22;P = 0.33)、关节痛的风险(RR:0.96,95%CI:0.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/4f9bfdf6987b/medi-98-e14042-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/5436feaefa84/medi-98-e14042-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/7e1cad75148d/medi-98-e14042-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/4453db162daa/medi-98-e14042-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/a1d03192e4f5/medi-98-e14042-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/4f9bfdf6987b/medi-98-e14042-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/5436feaefa84/medi-98-e14042-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/7e1cad75148d/medi-98-e14042-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/4453db162daa/medi-98-e14042-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/a1d03192e4f5/medi-98-e14042-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abdd/6336633/4f9bfdf6987b/medi-98-e14042-g009.jpg

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Effectiveness and safety of secukinumab in 69 patients with moderate to severe plaque psoriasis: A retrospective multicenter study.69 例中重度斑块型银屑病患者使用司库奇尤单抗的有效性和安全性:一项回顾性多中心研究。
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