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Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study.比较依奇珠单抗和乌司奴单抗治疗中重度银屑病:IXORA-S 三期研究 24 周结果。
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Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS).在一项针对中度至重度斑块状银屑病儿科患者的III期随机双盲安慰剂对照研究(IXORA-PEDS)中,司库奇尤单抗的疗效和安全性。
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本文引用的文献

1
Understanding Treatment Preferences in Patients with Moderate to Severe Plaque Psoriasis in the USA: Results from a Cross-Sectional Patient Survey.了解美国中重度斑块状银屑病患者的治疗偏好:一项横断面患者调查的结果
Dermatol Ther (Heidelb). 2019 Dec;9(4):785-797. doi: 10.1007/s13555-019-00334-1. Epub 2019 Oct 19.
2
Gender and age significantly determine patient needs and treatment goals in psoriasis - a lesson for practice.性别和年龄显著决定了银屑病患者的需求和治疗目标——对实践的启示。
J Eur Acad Dermatol Venereol. 2019 Apr;33(4):700-708. doi: 10.1111/jdv.15324. Epub 2019 Jan 15.
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Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis.在一项针对中度至重度斑块状银屑病患者的随机、开放标签研究中,司库奇尤单抗治疗可使临床症状早改善
J Clin Aesthet Dermatol. 2018 May;11(5):33-37. Epub 2018 May 1.
4
Effectiveness of and factors associated with clinical response to methotrexate under daily life conditions in Asian patients with psoriasis: A retrospective cohort study.在日常生活条件下,亚洲银屑病患者接受甲氨蝶呤治疗的临床应答效果及其相关因素:一项回顾性队列研究。
J Dermatol. 2018 May;45(5):540-545. doi: 10.1111/1346-8138.14270. Epub 2018 Mar 6.
5
Poor early response to methotrexate portends inadequate long-term outcomes in patients with moderate-to-severe psoriasis: Evidence from 2 phase 3 clinical trials.在中重度银屑病患者中,甲氨蝶呤早期应答不良预示着长期结局不佳:来自两项 3 期临床试验的证据。
J Am Acad Dermatol. 2017 Dec;77(6):1030-1037. doi: 10.1016/j.jaad.2017.08.017. Epub 2017 Oct 6.
6
Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study.比较依奇珠单抗和乌司奴单抗治疗中重度银屑病:IXORA-S 三期研究 24 周结果。
Br J Dermatol. 2017 Oct;177(4):1014-1023. doi: 10.1111/bjd.15666. Epub 2017 Jul 19.
7
Rapid improvements in health-related quality of life and itch with ixekizumab treatment in randomized phase 3 trials: results from UNCOVER-2 and UNCOVER-3.在随机 3 期临床试验中,依奇珠单抗治疗可迅速改善与健康相关的生活质量和瘙痒:UNCOVER-2 和 UNCOVER-3 的结果。
J Eur Acad Dermatol Venereol. 2017 Sep;31(9):1483-1490. doi: 10.1111/jdv.14211. Epub 2017 Jun 28.
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Patient-relevant treatment goals in psoriasis.银屑病中与患者相关的治疗目标。
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9
Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials.在中度至重度银屑病中比较依奇珠单抗与依那西普或安慰剂的疗效(UNCOVER-2 和 UNCOVER-3):两项 3 期随机临床试验的结果。
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10
PASI90 response: the new standard in therapeutic efficacy for psoriasis.银屑病面积和严重程度指数改善90%(PASI90)应答:银屑病治疗疗效的新标准。
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预测中重度斑块状银屑病患者长期皮肤病生活质量指数反应的早期治疗靶点:一项长期临床研究的分析

Early Treatment Targets for Predicting Long-term Dermatology Life Quality Index Response in Patients with Moderate-to-Severe Plaque Psoriasis: A Analysis from a Long-term Clinical Study.

作者信息

Puig Luis, Zhu Baojin, Burge Russel, Shrom David, Dong Yan, Shen Wei, Mallbris Lotus, Reich Kristian

机构信息

Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.

Drs. Zhu, Burge, Shrom, Dong, Shen, and Mallbris are with Eli Lilly and Company in Indianapolis, Indiana.

出版信息

J Clin Aesthet Dermatol. 2020 Oct;13(10):18-22. Epub 2020 Oct 1.

PMID:33584952
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7840086/
Abstract

: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. : We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). : The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. : Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. : Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.

摘要

据报道,接受白细胞介素(IL)-17A抗体司库奇尤单抗(IXE)治疗的患者与健康相关的生活质量(HRQoL)和银屑病严重程度有快速改善。我们在随机临床试验IXORA-S(NCT0256186)中评估了接受IXE或IL-12/23(优特克单抗[UST])治疗的患者早期银屑病面积和严重程度指数(PASI)反应与长期皮肤病生活质量指数(DLQI)改善之间的关系。通过第4、12和24周的PASI反应,对在接受IXE或UST治疗52周后达到DLQI(0,1)(相当于患者的皮肤状况对HRQoL无影响)的患者比例进行了量化。基于约登指数计算了按治疗分组的PASI反应预测第52周DLQI(0,1)的最佳阈值。无论采用何种治疗,早期和更高水平的皮肤清除与改善的患者预后相关。接受IXE治疗的患者比接受UST治疗的患者实现了更快、更显著的PASI反应。预测第52周DLQI(0,1)时,第4周IXE的最佳阈值约为PASI 75,而UST约为PASI 50;第12周IXE为PASI 90,UST为PASI 75;第24周IXE约为PASI 100,UST约为PASI 90。在达到这些阈值的患者中,实现DLQI(0,1)的概率显著更高。无论采用何种治疗,早期和更高水平的皮肤清除与长期改善的患者预后相关。