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阿达木单抗和司库奇尤单抗治疗中重度斑块状银屑病的疗效、安全性及药物经济学分析:一项单中心真实世界研究

Efficacy, Safety, and Pharmacoeconomic Analysis of Adalimumab and Secukinumab for Moderate-to-Severe Plaque Psoriasis: A Single-Center, Real-World Study.

作者信息

Li Gaojie, Gu Yuanxia, Zou Qin, Wang Yiyi, Xiao Yue, Xia Dengmei, Zhan Tongying, Zhou Xingli, Wang Qian, Yan Wei, Li Wei

机构信息

Department of Dermatology and Venereology, Rare Diseases Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.

Department of Dermatology, Chengdu Second People's Hospital, Chengdu, 610011, Sichuan, China.

出版信息

Dermatol Ther (Heidelb). 2022 Sep;12(9):2105-2115. doi: 10.1007/s13555-022-00787-x. Epub 2022 Aug 11.

Abstract

INTRODUCTION

A growing number of biologics have recently been approved in China for psoriasis treatment, and some of these are eligible for Chinese medical insurance, resulting in a significant increase in the number of patients receiving these biologics. Nevertheless, real-world data on the efficacy and safety of biologics for treating moderate-to-severe plaque psoriasis in Chinese patients are limited, and relevant pharmacoeconomic studies are lacking. Therefore, we performed a prospective, single-center study to evaluate the efficacy and safety of adalimumab (ADA) and secukinumab (SEC) in real-world practice. A cost-effectiveness analysis (CEA) was also conducted.

METHODS

Participants were enrolled between January 2019 and December 2020 at the West China Hospital, Sichuan University. Baseline and follow-up assessments were conducted, and an appropriate statistical analysis was performed.

RESULTS

A total of 183 patients were included. At week 12, the number of patients achieving a psoriasis area and severity index reduction of 75% (PASI 75) with SEC treatment was higher than that with ADA and methotrexate (MTX) (SEC versus ADA versus MTX, 90.59% versus 58.70% versus 17.14%, respectively). Adverse events (AEs) were reported in 44.83% and 56.36% of patients in the SEC and ADA groups, respectively. The cost-effectiveness ratio in the SEC group was 46,311.83 Chinese yuan(CNY), compared with 17,580.92 CNY in the ADA group.

CONCLUSION

In real-world practice, SEC and ADA are effective and safe for moderate-to-severe plaque psoriasis treatment in Chinese patients. On the basis of drug prices during our study period without considering access to health insurance, ADA was more cost-effective in real-world practice. Adalimumab and secukinumab are two monoclonal antibodies used for the treatment of psoriasis, which target different cytokines in the pathogenesis. A growing number of biologics have recently been approved in China for psoriasis treatment including adalimumab and secukinumab, which are eligible for Chinese medical insurance, resulting in a significant increase in the number of patients receiving these biologics. With the purpose of evaluating its efficacy and safety in the real world, we registered the data of eligible patients in West China Hospital, Sichuan University over the past two years and conducted statistical analysis. In order to provide different therapeutic strategies for patients based on case-specific needs and access to financial resources, we performed pharmacoeconomic analyses to evaluate the cost-effectiveness of the two drugs. Our study demonstrated that adalimumab and secukinumab were effective and safe for moderate-to-severe plaque psoriasis in Chinese patients in the real-world practice. Based on drug prices during our study period and without taking into consideration access to health insurance, ADA was more cost-effective in real-world practice.

摘要

引言

近年来,越来越多的生物制剂在中国获批用于治疗银屑病,其中一些已被纳入医保,这使得接受这些生物制剂治疗的患者数量显著增加。然而,关于生物制剂治疗中国中重度斑块状银屑病的疗效和安全性的真实世界数据有限,相关的药物经济学研究也较为缺乏。因此,我们开展了一项前瞻性单中心研究,以评估阿达木单抗(ADA)和司库奇尤单抗(SEC)在实际临床中的疗效和安全性,并进行了成本效益分析(CEA)。

方法

研究对象于2019年1月至2020年12月期间在四川大学华西医院入组。进行了基线和随访评估,并进行了适当的统计分析。

结果

共纳入183例患者。在第12周时,接受SEC治疗达到银屑病面积和严重程度指数改善75%(PASI 75)的患者数量高于接受ADA和甲氨蝶呤(MTX)治疗的患者(SEC组与ADA组与MTX组分别为90.59%、58.70%和17.14%)。SEC组和ADA组分别有44.83%和56.36%的患者报告了不良事件(AE)。SEC组的成本效益比为46,311.83元人民币(CNY),而ADA组为17,580.92元人民币。

结论

在实际临床中,SEC和ADA治疗中国中重度斑块状银屑病有效且安全。根据我们研究期间的药品价格,在不考虑医保报销的情况下,ADA在实际临床中更具成本效益。阿达木单抗和司库奇尤单抗是两种用于治疗银屑病的单克隆抗体,它们在发病机制中靶向不同的细胞因子。近年来,越来越多的生物制剂包括阿达木单抗和司库奇尤单抗在中国获批用于治疗银屑病,且这些药物已被纳入医保,使得接受这些生物制剂治疗的患者数量显著增加。为了评估其在真实世界中的疗效和安全性,我们收集了四川大学华西医院过去两年符合条件患者的数据并进行统计分析。为了根据患者的具体需求和经济状况提供不同的治疗策略,我们进行了药物经济学分析以评估这两种药物的成本效益。我们的研究表明,在实际临床中,阿达木单抗和司库奇尤单抗治疗中国中重度斑块状银屑病有效且安全。根据我们研究期间的药品价格且不考虑医保报销情况,ADA在实际临床中更具成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0db2/9464289/1311bc288347/13555_2022_787_Fig1_HTML.jpg

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