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来自PSoHO的中重度斑块状银屑病合并甲银屑病患者使用生物制剂治疗的基线特征以及从基线评分到第12个月的mNAPSI变化

Baseline Characteristics and mNAPSI Change from Baseline Scores Through Month 12 for Patients with Moderate-to-Severe Plaque Psoriasis and Concomitant Nail Psoriasis Treated with Biologics from PSoHO.

作者信息

Riedl Elisabeth, Pinter Andreas, Zaheri Shirin, Costanzo Antonio, Brnabic Alan, Konicek Bruce, McKenzie Robert, Lampropoulou Anastasia, Rayes Mohamed El, Haustrup Natalie, Schuster Christopher

机构信息

Department of Dermatology, Medical University of Vienna, Vienna, Austria.

University Hospital Frankfurt, Frankfurt Am Main, Germany.

出版信息

Dermatol Ther (Heidelb). 2024 May;14(5):1327-1335. doi: 10.1007/s13555-024-01150-y. Epub 2024 Apr 22.

Abstract

INTRODUCTION

Nail psoriasis is highly prevalent among patients with psoriasis yet remains one of the most challenging areas to treat. To better understand the treatment landscape for psoriatic nail disease, more studies are needed that compare the effectiveness of different biologics for patients with nail psoriasis. This study contributes to this objective by directly comparing the effectiveness of approved biologics in improving nail psoriasis for patients up to month 12 in a real-world setting.

METHODS

Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. This study assessed the change in modified Nail Psoriasis Severity Index (mNAPSI) score from baseline to months 3, 6 and 12 for 763 patients and compared the effectiveness of anti-interleukin (IL)-17A biologics versus other approved biologics, as well as ixekizumab versus secukinumab, guselkumab, risankizumab and adalimumab. Comparative adjusted analyses used frequentist model averaging (FMA). Least square mean difference (LSMD) in mNAPSI scores are presented as observed.

RESULTS

Irrespective of the severity of nail psoriasis at baseline, the anti-IL-17A cohort had greater mean mNAPSI reductions from baseline compared to the other biologics cohort through month 12, reaching significance at months 3 and 6 in the adjusted analysis. For patients with moderate-to-severe nail psoriasis, ixekizumab showed numerically higher mean reductions in mNAPSI scores compared to all other studied biologics, reaching significance versus guselkumab at all timepoints and risankizumab at month 6.

CONCLUSION

This real-world study showed that patients with moderate-to-severe psoriasis and any severity of concomitant nail involvement had significantly faster and more substantial improvements in nail psoriasis up to month 6 in the anti-IL-17A cohort compared to the other biologics cohort. Of the individual biologics studied, ixekizumab showed the highest numerical improvements in nail psoriasis at month 12.

TRIAL REGISTRATION

EUPAS24207.

摘要

引言

指甲银屑病在银屑病患者中极为常见,但仍是最难治疗的领域之一。为了更好地了解银屑病指甲疾病的治疗情况,需要开展更多研究来比较不同生物制剂对指甲银屑病患者的疗效。本研究通过在真实环境中直接比较已获批生物制剂在改善指甲银屑病方面长达12个月的疗效,为实现这一目标做出了贡献。

方法

银屑病健康结局研究(PSoHO)是一项正在进行的为期3年的前瞻性、非干预性队列研究,研究对象为开始使用或改用新生物制剂的慢性中度至重度斑块状银屑病成人患者。本研究评估了763例患者从基线到第3、6和12个月时改良指甲银屑病严重程度指数(mNAPSI)评分的变化,并比较了抗白细胞介素(IL)-17A生物制剂与其他已获批生物制剂的疗效,以及依奇珠单抗与司库奇尤单抗、古塞库单抗、瑞莎珠单抗和阿达木单抗的疗效。比较性调整分析采用频率学派模型平均法(FMA)。mNAPSI评分的最小二乘均值差异(LSMD)按观察值呈现。

结果

无论基线时指甲银屑病的严重程度如何,在第12个月时,与其他生物制剂队列相比,抗IL-17A队列从基线开始的mNAPSI平均降低幅度更大,在调整分析中第3和6个月时达到显著水平。对于中度至重度指甲银屑病患者,依奇珠单抗的mNAPSI评分平均降低数值高于所有其他研究的生物制剂,在所有时间点与古塞库单抗相比以及在第6个月时与瑞莎珠单抗相比均达到显著水平。

结论

这项真实环境研究表明,与其他生物制剂队列相比,中度至重度银屑病且伴有任何严重程度指甲受累的患者,在抗IL-17A队列中,直到第6个月时指甲银屑病的改善显著更快且更明显。在所研究的各生物制剂中,依奇珠单抗在第12个月时指甲银屑病的改善数值最高。

试验注册

EUPAS24207

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f09/11116304/ceae58f86d6f/13555_2024_1150_Fig1_HTML.jpg

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