THE REAL-WORLD TREATMENT PATTERNS AND CLINICAL OUTCOMES IN MODERATE-TO-SEVERE ATOPIC DERMATITIS (AD) PATIENTS RECEIVING ABROCITINIB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52
研究概览
简要总结
This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Patients aged ≥12 years
- •Patients with confirmed diagnosis of moderate-to-severe AD as assessed by the physician
- •Patients for whom the physician's decision has been made to newly prescribe abrocitinib in usual clinical practice conditions
- •Evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Any prior use of abrocitinib
- •Simultaneous participation in a study that includes administration of any investigational drug or procedure
结局指标
主要结局
Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52
时间窗: Week 2, 12, 52
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52
时间窗: Week 2, 12, 52
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52
时间窗: Week 2, 12, 52
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
次要结局
- Duration of Abrocitinib Treatment: All Participants(During post-index period (12 months duration post index date))
- Demographic and baseline characteristics(During pre-index period)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52(Baseline, Week 2, 4, 12, and 52)
- Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52(Baseline, Week 2, 4, 12, and 52)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52(Baseline, Week 2, 4, 12, and 52)
- Change From Baseline in Patient Global Assessment (PtGA)(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)
- Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52(Baseline, Week 2, 4, 12, 16, 24, and 52)