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中重度银屑病患者换用阿达木单抗后的银屑病面积和严重程度指数应答:OPPSA 研究结果。

Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.

机构信息

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

Department of Medical and Surgical Sciences and Biotechnologies, Division of Dermatology 'Daniele Innocenzi', University of Rome 'La Sapienza', Polo Pontino, Italy.

出版信息

J Eur Acad Dermatol Venereol. 2018 Oct;32(10):1737-1744. doi: 10.1111/jdv.15077. Epub 2018 Jun 1.

DOI:10.1111/jdv.15077
PMID:29776016
Abstract

BACKGROUND

Few studies have compared the efficacy of switching to adalimumab in the real-life setting in plaque psoriasis patients.

OBJECTIVE

To evaluate the effect of adalimumab in psoriasis patients previously treated with other biologics.

METHODS

In this multicentre study, psoriasis patients (N = 262) treated with an anti-TNF-alpha agent, ustekinumab or naïve to biologics then switched to adalimumab were included. Disease severity was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 3, 6, 12, 24 and 36 months. The association between clinical risk factors and achievement of PASI response was evaluated by logistic regression.

RESULTS

Adalimumab treatment resulted in a decrease in PASI (15.1 ± 6.2 at baseline vs. 2.7 ± 4.8 at 6 months, P < 0.0001), regardless of previous biologic treatment. Furthermore, adalimumab allowed 92.5%, 79% and 56% of patients to achieve PASI response (PASI 50, 75 and 90, respectively) and complete remission (PASI 100 response) in 48.4% of patients, by 6 months and maintained over 3 years, independent of prior biologic treatment. The absence of metabolic syndrome, dyslipidemia, hypertension and lower PASI and lower age at baseline was associated with achievement of PASI response at 3, 6 and 12 months, whereas at later time points (24 and 36 months), PASI 90 and PASI 100 response was associated with diagnosis of psoriasis/psoriatic arthritis.

CONCLUSION

Adalimumab was effective at reducing PASI score over 3 years, irrespective of whether patients were biologic naïve or previously treated with a TNF-alpha or IL-12/23 inhibitor.

摘要

背景

很少有研究比较过在斑块状银屑病患者的真实环境中改用阿达木单抗的疗效。

目的

评估阿达木单抗对先前接受过其他生物制剂治疗的银屑病患者的疗效。

方法

在这项多中心研究中,纳入了接受抗 TNF-α 药物、乌司奴单抗或未接受生物制剂治疗的银屑病患者(N=262),然后将其转换为阿达木单抗治疗。在基线和治疗后 3、6、12、24 和 36 个月时,使用银屑病面积和严重程度指数(PASI)评估疾病严重程度。通过逻辑回归评估临床危险因素与 PASI 应答之间的关系。

结果

阿达木单抗治疗可降低 PASI(基线时为 15.1±6.2,治疗 6 个月时为 2.7±4.8,P<0.0001),与先前的生物制剂治疗无关。此外,阿达木单抗治疗 6 个月后,92.5%、79%和 56%的患者达到 PASI 应答(PASI 50、75 和 90),48.4%的患者达到完全缓解(PASI 100 应答),且在 3 年内保持不变,与先前的生物制剂治疗无关。无代谢综合征、血脂异常、高血压以及基线 PASI 较低和年龄较小与 3、6 和 12 个月时达到 PASI 应答相关,而在较晚的时间点(24 和 36 个月),PASI 90 和 PASI 100 应答与银屑病/银屑病关节炎的诊断相关。

结论

阿达木单抗在 3 年内降低 PASI 评分的效果显著,无论患者是否为生物制剂初治或先前接受过 TNF-α 或 IL-12/23 抑制剂治疗。

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