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依奇珠单抗治疗真实临床环境中中重度斑块型银屑病患者。

Ixekizumab treatment in patients with moderate-to-severe plaque psoriasis in a real-world clinical setting.

机构信息

Department of Dermatology and Venereology, Uşak Training and Research Hospital, Uşak, Turkey.

Department of Dermatology and Venereology, İzmir Democracy University, İzmir, Turkey.

出版信息

J Cosmet Dermatol. 2022 Nov;21(11):6215-6224. doi: 10.1111/jocd.15217. Epub 2022 Jul 18.

DOI:10.1111/jocd.15217
PMID:35801372
Abstract

BACKGROUND

The efficacy and safety reports of ixekizumab for moderate-to-severe plaque psoriasis may vary between clinical trials and real-world studies.

AIM

To analyze the real-world data of ixekizumab therapy to evaluate its efficacy and safety and highlight the factors influencing the treatment response in the real-world scenario.

PATIENTS/METHODS: Data of 82 adult patients with moderate-to-severe chronic plaque psoriasis are included in this study. Psoriasis area severity index (PASI) 75/90/100 responses at 4, 16, 24, and 48 weeks were analyzed retrospectively from patient charts by examining demographic and clinical characteristics of the patients, especially their previous biologic experience, obesity, and involvement of hard-to-treat areas.

RESULTS

PASI75, PASI90, and PASI100 responses were achieved in 92.4%, 86.1%, and 26.6% patients at week 16 and maintained till week 48 in 92.3%, 86.5%, and 17.3% patients. PASI90 responses in obese patients were significantly lower than non-obese patients at week 4 (33.3% vs. 69.6%, p = 0.042), but this difference was minimized by week 16 (82.4% vs. 90%, p = 0.405). PASI90 responses in biologic-naive patients were significantly higher than biologic-experienced patients at week 16 (p = 0.015). Involvement of hard-to-treat areas was negatively associated with PASI90 responses at week 16 (OR: 1591805.842; 95% CI: 1.223-2071404486740.201; p = 0.047).

CONCLUSION

Ixekizumab provides an effective and safe biologic treatment option to patients with moderate-to-severe plaque psoriasis. Obesity, though it affects the early treatment response (till week 4), does not upset the overall treatment response beyond week 16. Previous biologic exposure and involvement of hard-to-treat areas are important prognostic factors for achieving high PASI responses in psoriatic patients.

摘要

背景

依奇珠单抗治疗中重度斑块状银屑病的疗效和安全性在临床试验和真实世界研究中可能存在差异。

目的

分析依奇珠单抗治疗的真实世界数据,评估其疗效和安全性,并强调真实世界环境中影响治疗反应的因素。

患者/方法:本研究纳入了 82 例中重度慢性斑块状银屑病成年患者的数据。通过检查患者的人口统计学和临床特征,特别是他们以前的生物制剂治疗经验、肥胖和治疗困难区域的受累情况,从病历中回顾性分析了第 4、16、24 和 48 周时患者的银屑病面积严重程度指数(PASI)75/90/100 缓解情况。

结果

第 16 周时,92.4%、86.1%和 26.6%的患者达到了 PASI75、PASI90 和 PASI100 缓解,第 48 周时,92.3%、86.5%和 17.3%的患者维持了这一缓解。第 4 周时,肥胖患者的 PASI90 缓解率明显低于非肥胖患者(33.3% vs. 69.6%,p=0.042),但这一差异在第 16 周时已最小化(82.4% vs. 90%,p=0.405)。第 16 周时,生物制剂初治患者的 PASI90 缓解率明显高于生物制剂经治患者(p=0.015)。治疗困难区域的受累与第 16 周时的 PASI90 缓解率呈负相关(OR:1591805.842;95%CI:1.223-2071404486740.201;p=0.047)。

结论

依奇珠单抗为中重度斑块状银屑病患者提供了一种有效且安全的生物治疗选择。肥胖虽然会影响早期治疗反应(至第 4 周),但不会影响第 16 周后总体治疗反应。既往生物制剂治疗和治疗困难区域的受累是影响银屑病患者获得高 PASI 缓解的重要预后因素。

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