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在临床和真实世界研究中,比较接受司库奇尤单抗治疗的斑块状银屑病患者与接受其他生物制剂治疗的患者在实现国家银屑病基金会治疗目标方面的情况。

Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies.

作者信息

Armstrong April, González-Cantero Alvaro, Khattri Saakshi, Muzy Guilherme, Malatestinic William N, Lampropoulou Anastasia, Feely Meghan, See Sophia Kyoungah, Mert Can, Blauvelt Andrew

机构信息

University of California Los Angeles, Los Angeles, CA, USA.

Ramón y Cajal University Hospital, Madrid, Spain.

出版信息

Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.

Abstract

INTRODUCTION

The National Psoriasis Foundation (NPF) recommends evaluating patient response to treatment at week 12, with a target response of ≤ 1% body surface area (BSA) affected by plaque psoriasis and an acceptable response of BSA ≤ 3% or ≥ 75% improvement. This post hoc analysis compared the achievement of NPF target and acceptable responses for ixekizumab (IXE) versus other biologics.

METHODS

Outcomes were evaluated at week 12 for patients with moderate-to-severe plaque psoriasis from four head-to-head randomized clinical trials (RCTs; UNCOVER-2, UNCOVER-3, IXORA-R, and IXORA-S) and one real-world prospective observational study (Psoriasis Study of Health Outcomes; PSoHO). RCT patients were treated with IXE or etanercept (ETN; UNCOVER-2/3), guselkumab (GUS; IXORA-R), or ustekinumab (UST; IXORA-S). PSoHO patients were treated with anti-interleukin (IL)-17A biologics (IXE, secukinumab, SEC) and other approved biologics for the treatment of plaque psoriasis. Patients with missing outcomes were imputed as non-responder imputation. For RCT data, statistical comparisons between treatment groups were performed using Fisher's exact test with no multiplicity adjustments. For real-world data, adjusted comparative analyses were performed using frequentist model averaging (FMA) and reported as odds ratio (OR).

RESULTS

Across the four head-to-head clinical trials analyzed, significantly higher proportions of patients achieved target and acceptable responses at week 12 with IXE versus ETN, GUS, or UST. Likewise, the proportion of PSoHO patients achieving target and acceptable response at week 12 was higher with IXE compared with other individual biologics. Adjusted comparative analyses showed that IXE had significantly greater odds of target and acceptable response at week 12 versus SEC, GUS, risankizumab (RIS), adalimumab (ADA), UST, and tildrakizumab (TILD) and numerically greater odds of target and acceptable response at week 12 versus brodalumab (BROD).

CONCLUSION

Across both clinical studies and real-world settings, more patients treated with IXE achieved NPF target and acceptable responses at week 12 compared with those treated with other biologics.

TRIAL REGISTRATION

UNCOVER-2 (NCT01597245); UNCOVER-3 (NCT01646177); IXORA-R (NCT03573323); IXORA-S (NCT02561806); PSoHO (EUPAS24207).

摘要

引言

美国国家银屑病基金会(NPF)建议在第12周评估患者对治疗的反应,目标反应为斑块状银屑病累及的体表面积(BSA)≤1%,可接受的反应为BSA≤3%或改善≥75%。这项事后分析比较了ixekizumab(IXE)与其他生物制剂在实现NPF目标反应和可接受反应方面的情况。

方法

对四项头对头随机临床试验(RCTs;UNCOVER - 2、UNCOVER - 3、IXORA - R和IXORA - S)以及一项真实世界前瞻性观察研究(银屑病健康结局研究;PSoHO)中中度至重度斑块状银屑病患者在第12周的结局进行评估。RCT患者接受IXE或依那西普(ETN;UNCOVER - 2/3)、古塞库单抗(GUS;IXORA - R)或乌司奴单抗(UST;IXORA - S)治疗。PSoHO患者接受抗白细胞介素(IL)-17A生物制剂(IXE、司库奇尤单抗、SEC)和其他已批准的用于治疗斑块状银屑病的生物制剂治疗。结局缺失的患者按无反应者进行推算。对于RCT数据,治疗组之间的统计比较采用Fisher精确检验,不进行多重性调整。对于真实世界数据,采用频率学派模型平均法(FMA)进行调整后的比较分析,并以比值比(OR)报告。

结果

在分析的四项头对头临床试验中,与ETN、GUS或UST相比,第12周时接受IXE治疗的患者达到目标反应和可接受反应的比例显著更高。同样,与其他单一生物制剂相比,第12周时PSoHO患者中接受IXE治疗达到目标反应和可接受反应的比例更高。调整后的比较分析表明,与SEC、GUS、司库奇尤单抗(RIS)、阿达木单抗(ADA)、UST和替拉珠单抗(TILD)相比,第12周时IXE达到目标反应和可接受反应有显著更高的比值比,与布罗达单抗(BROD)相比,第12周时达到目标反应和可接受反应的比值比在数值上更高。

结论

在临床研究和真实世界环境中,与接受其他生物制剂治疗的患者相比,接受IXE治疗的更多患者在第12周时达到了NPF目标反应和可接受反应。

试验注册

UNCOVER - 2(NCT01597245);UNCOVER - 3(NCT01646177);IXORA - R(NCT03573323);IXORA - S(NCT02561806);PSoHO(EUPAS24207)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/762b/11052751/c7c108c19957/13555_2024_1136_Fig1_HTML.jpg

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