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一项单中心、观察性、回顾性、真实世界研究,评估阿达木单抗生物类似药 ABP 501 治疗初治患者的斑块型银屑病和银屑病关节炎,以及非医学转换自原研药的患者。

A single-centre, observational, retrospective, real-life study evaluating adalimumab biosimilar ABP 501 in the treatment of plaque-type psoriasis and psoriatic arthritis in originator-naïve patients and in patients undergoing non-medical switch from originator.

机构信息

Department of Dermatology, University of Rome Tor Vergata, Rome, Italy.

出版信息

Curr Med Res Opin. 2021 Jul;37(7):1099-1102. doi: 10.1080/03007995.2021.1923467. Epub 2021 May 20.

Abstract

BACKGROUND

ABP 501 is a biosimilar to the anti-tumor necrosis factor-alfa monoclonal antibody adalimumab and despite its effectiveness and safety in the treatment of psoriasis was demonstrated in randomized clinical trials, no real-life data are available, in particular in patients undergoing non-medical switch from originator to biosimilar.

METHODS

We retrospectively searched our clinical records for all patients receiving ABP 501 between March 10, 2019 and September 7, 2019 at our Department. Therefore, we identified 94 patients, 46 patients underwent non-medical switch from adalimumab reference product to ABP 501.

RESULTS

In originator-naïve patients, mean PASI significantly improved from baseline to week 24 ( < .0001) in both Pso and PsA cohorts. In these patients, mean DAS-28 ESR improved with no significant differences from baseline. In patients undergoing non-medical switch from adalimumab reference product to ABP 501, no significant difference in PASI or DAS-28 ESR were observed from week 16 before switch to week 24 after switch.

CONCLUSIONS

AB- 501 is an effective treatment for plaque-type psoriasis and psoriatic arthritis regardless if patients are originator-naïve or if they were switched from the reference product.

摘要

背景

ABP501 是一种抗肿瘤坏死因子-α单克隆抗体阿达木单抗的生物类似药,尽管其在治疗银屑病方面的有效性和安全性已在随机临床试验中得到证实,但尚无实际数据,特别是在非医学原因从原研药转换为生物类似药的患者中。

方法

我们回顾性地检索了我们的临床记录,以查找 2019 年 3 月 10 日至 2019 年 9 月 7 日期间在我们科室接受 ABP501 治疗的所有患者。因此,我们确定了 94 例患者,其中 46 例患者因非医学原因从阿达木单抗原研药转换为 ABP501。

结果

在原研药初治患者中,Pso 和 PsA 队列的 PASI 评分均从基线显著改善至第 24 周( < 0.0001)。在这些患者中,DAS-28 ESR 也有所改善,与基线相比无显著差异。在因非医学原因从阿达木单抗原研药转换为 ABP501 的患者中,从转换前的第 16 周至转换后的第 24 周,PASI 或 DAS-28 ESR 均无显著差异。

结论

ABP501 是一种有效的斑块型银屑病和银屑病关节炎治疗药物,无论患者是否为原研药初治或是否从原研药转换而来。

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