PDF(Pubmed)
Abstract：
BACKGROUND: 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).
CONCLUSIONS: 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.
BACKGROUND: UNCOVER-2 (NCT01597245); UNCOVER-3 (NCT01646177); IXORA-R (NCT03573323); IXORA-S (NCT02561806); PSoHO (EUPAS24207).
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).
CONCLUSIONS: 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.
BACKGROUND: UNCOVER-2 (NCT01597245); UNCOVER-3 (NCT01646177); IXORA-R (NCT03573323); IXORA-S (NCT02561806); PSoHO (EUPAS24207).
摘要：
背景：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≤1％的体表面积（BSA）受斑块状银屑病影响，可接受的反应≤3％或≥75％的BSA改善。该事后分析比较了ixekizumab（IXE）与其他生物制剂的NPF目标和可接受反应的实现。
方法：在第12周评估了来自四个头对头随机临床试验（RCT；UNCOVER-2，UNCOVER-3，IXORA-R，和IXORA-S）和一项现实世界的前瞻性观察研究（银屑病健康结局研究；PSoHO）。RCT患者接受IXE或依那西普（ETN;UNCOVER-2/3）治疗，guselkumab（GUS；IXORA-R），或ustekinumab（UST;IXORA-S）。PSoHO患者接受了抗白细胞介素（IL）-17A生物制剂（IXE，苏金单抗，SEC）和其他批准的用于治疗斑块状银屑病的生物制剂。结果缺失的患者被归入无反应者归因。对于RCT数据，治疗组之间的统计学比较采用Fisher精确检验,无多重性校正.对于真实世界的数据，使用频率模型平均(FMA)进行校正比较分析,并报告为比值比(OR).
结果：在四个头对头临床试验中进行了分析，在第12周，IXE与ETN相比，达到目标和可接受反应的患者比例明显更高，GUS,或UST。同样，与其他个体生物制剂相比,接受IXE治疗的PSoHO患者在第12周达到目标和可接受缓解的比例更高.调整后的比较分析显示，与SEC相比，IXE在第12周的目标和可接受反应的几率明显更高，GUS,利安珠单抗（RIS），阿达木单抗（ADA），UST,和tildrakizumab（TILD），与Brodalumab（BROD）相比，在第12周时达到目标和可接受反应的几率更高。
结论：在临床研究和现实环境中，与接受其他生物制剂治疗的患者相比,接受IXE治疗的患者在第12周有更多的患者达到NPF目标和可接受的缓解.
背景:UNCOVER-2(NCT01597245);UNCOVER-3(NCT01646177);IXORA-R(NCT03573323);IXORA-S(NCT02561806);PSoHO(EUPAS24207)。
方法：在第12周评估了来自四个头对头随机临床试验（RCT；UNCOVER-2，UNCOVER-3，IXORA-R，和IXORA-S）和一项现实世界的前瞻性观察研究（银屑病健康结局研究；PSoHO）。RCT患者接受IXE或依那西普（ETN;UNCOVER-2/3）治疗，guselkumab（GUS；IXORA-R），或ustekinumab（UST;IXORA-S）。PSoHO患者接受了抗白细胞介素（IL）-17A生物制剂（IXE，苏金单抗，SEC）和其他批准的用于治疗斑块状银屑病的生物制剂。结果缺失的患者被归入无反应者归因。对于RCT数据，治疗组之间的统计学比较采用Fisher精确检验,无多重性校正.对于真实世界的数据，使用频率模型平均(FMA)进行校正比较分析,并报告为比值比(OR).
结果：在四个头对头临床试验中进行了分析，在第12周，IXE与ETN相比，达到目标和可接受反应的患者比例明显更高，GUS,或UST。同样，与其他个体生物制剂相比,接受IXE治疗的PSoHO患者在第12周达到目标和可接受缓解的比例更高.调整后的比较分析显示，与SEC相比，IXE在第12周的目标和可接受反应的几率明显更高，GUS,利安珠单抗（RIS），阿达木单抗（ADA），UST,和tildrakizumab（TILD），与Brodalumab（BROD）相比，在第12周时达到目标和可接受反应的几率更高。
结论：在临床研究和现实环境中，与接受其他生物制剂治疗的患者相比,接受IXE治疗的患者在第12周有更多的患者达到NPF目标和可接受的缓解.
背景:UNCOVER-2(NCT01597245);UNCOVER-3(NCT01646177);IXORA-R(NCT03573323);IXORA-S(NCT02561806);PSoHO(EUPAS24207)。
