来自英国皮肤科医师协会生物和免疫调节剂登记册(BADBIR)的SB5(阿达木单抗生物类似药)治疗中重度牛皮癣患者的长期真实证据。

Giampiero Girolomoni, Steven R Feldman, Alexander Egeberg, Luis Puig, Jinah Jung, Hojung Jung, Younju Lee
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摘要

背景:SB5(阿达木单抗-bwwd)是一种靶向肿瘤坏死因子(TNF)的阿达木单抗生物类似药,用于治疗慢性炎症性疾病,包括中重度慢性斑块性银屑病。目的:评估英国和爱尔兰银屑病患者中SB5的有效性和安全性的四年持续性。方法:这项前瞻性研究纳入了1195名接受sb5治疗的患者,这些患者在2018年6月1日至2022年8月31日期间使用了英国皮肤科医生协会的生物干预登记册(BADBIR)。持续时间定义为从生物治疗开始到停药的时间,Kaplan-Meier分析用于评估SB5停药率。采用Cox回归分析潜在协变量对SB5首次停药时间的影响。结果:SB5 1年、2年、3年和4年停药率分别为26.5%、37.2%、41.9%和43.3%。被测试的协变量,如转换、年龄、性别、体重指数(BMI)和牛皮癣持续时间,对SB5的停药率没有显著影响。结论:在临床实践中,以bio-naïve为主的银屑病患者中SB5的中位持续时间约为2.5年。结果表明,SB5可以自信地用于牛皮癣患者,提供与阿达木单抗相当的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term real-world evidence of SB5 (adalimumab biosimilar) treatment in patients with moderate-to-severe psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR).

Background: SB5 (adalimumab-bwwd) is an adalimumab biosimilar targeting tumor necrosis factor (TNF) for the treatment of chronic inflammatory diseases, including moderate-to-severe chronic plaque psoriasis.

Objectives: To assess the four-year persistence associated with the effectiveness and safety of SB5 in patients with psoriasis in the UK and Ireland.

Methods: This prospective study included 1195 SB5-treated patients using British Association of Dermatologists' Biologic Interventions Register (BADBIR) between 01 June 2018 and 31 August 2022. Persistence was defined as the time from biologic therapy initiation to discontinuation and Kaplan-Meier analysis was used to evaluate SB5 discontinuation rates. Cox regression was used to investigate the effect of covariates on the time-to-first-discontinuation of SB5 with the potential covariates.

Results: SB5 one-, two-, three-, and four-year discontinuation rates were 26.5%, 37.2%, 41.9%, and 43.3%, respectively. Tested covariates such as switching, age, sex, body mass index (BMI), and duration of psoriasis did not significantly affect the discontinuation rate of SB5.

Conclusions: Median persistence of SB5 in predominantly bio-naïve psoriasis patients was about 2.5 years in clinical practice. The results suggest that SB5 can be confidently used for patients with psoriasis, offering comparable outcomes to reference adalimumab.

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