Higher levels of response on clinical atopic dermatitis severity measures are associated with meaningful improvements in patient-reported symptom and quality of life measures: Integrated analysis of three Upadacitinib phase 3 trials

被引:9
作者
Reich, K. [1 ]
de Bruin-Weller, M. S. [2 ]
Deleuran, M. [3 ]
Calimlim, B. M. [4 ]
Chen, N. [4 ]
Hu, X. [4 ]
Tenorio, A. R. [4 ]
Silverberg, J. I. [5 ,6 ]
机构
[1] Univ Med Ctr Hamburg Eppendorf, Inst Hlth Serv Res Dermatol & Nursing, Translat Res Inflammatory Skin Dis, Hamburg, Germany
[2] Univ Med Ctr Utrecht, Natl Expertise Ctr Atop Dermatitis, Dept Dermatol & Allergol, Utrecht, Netherlands
[3] Aarhus Univ Hosp, Dept Dermatol, Aarhus, Denmark
[4] AbbVie Inc, N Chicago, IL USA
[5] George Washington Univ, Dept Dermatol, Sch Med & Hlth Sci, Washington, DC USA
[6] George Washington Univ, Dept Dermatol, Sch Med & Hlth Sci, 2150 Penn Ave NW,Suite 2B-430, Washington, DC 20037 USA
关键词
DOUBLE-BLIND; MODERATE; INDEX; ABROCITINIB; ADOLESCENTS; PLACEBO; ADULTS; ITCH;
D O I
10.1111/jdv.18995
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
BackgroundIt is not fully understood how different degrees of improvements in atopic dermatitis (AD) clinical outcome measures translate to improvements in patient-reported outcome (PRO) measures, such as those assessing itch, symptoms, sleep, anxiety, depression, quality of life (QoL), and work productivity. ObjectivesThis post hoc analysis of three clinical studies assessed how more robust improvements in clinical responses are associated with improvements in PROs and QoL. MethodsData from three randomized, double-blind, placebo-controlled, phase 3 trials in adults and adolescents with moderate to severe atopic dermatitis (Measure Up 1, Measure Up 2, and AD Up) were included. Patients were randomly assigned (1:1:1) to upadacitinib (15 or 30 mg) or placebo once daily (alone or in combination with topical corticosteroids). The mean percentage improvement from baseline to week 16 and percentage of patients achieving responses at week 16 were summarized by the Eczema Area and Severity Index (EASI) and validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) response level categories. ResultsA total of 2392 patients from the three trials were included in the analysis. Increasingly greater mean percentage improvement and proportion of patients achieving response was observed at higher clinical response levels (i.e., stepwise pattern). Mean percentage improvement and proportion of patients achieving response exceeded 69% and 70% at EASI >= 90 and vIGA-AD 0/1, respectively, for most PROs including Worst Pruritus Numeric Rating Scale, Patient Oriented Eczema Measure, and Dermatology Life Quality Index. ConclusionsGreater degrees of clinical responses are related to more robust improvements across multiple dimensions impacted by AD, including itch, skin pain, sleep, anxiety, depression, and QoL.
引用
收藏
页码:1634 / 1641
页数:8
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