This is a Prospective, Single-arm, Multicenter, Observational Non-interventional Study (NIS) in Germany of Patient Characteristics, Usage, and Effectiveness of Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 112
- 试验地点
- 38
- 主要终点
- Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3
研究概览
简要总结
The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):
- Are aged at least 18 years old
- Have a confirmed diagnosis of AD by a skin doctor
- Decide to start treatment with Abrocitinib as part of routine clinical practice
- Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects
Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 years
- •Confirmed diagnosis of AD by dermatologist prior to study inclusion
- •Patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being
- •abrocitinib naive or,
- •patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion
- •Patient is eligible for abrocitinib treatment according to Summary of Product Characteristics (SmPC)
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study
排除标准
- •Contraindications according to SmPC
- •Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period
- •Patients being treated with abrocitinib within a time period of <28 days prior to the timepoint of study inclusion
- •Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the non-interventional study
- •Patients who are unable to consent
结局指标
主要结局
Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3
时间窗: At Month 3
The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of body surface area \[BSA\] affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\*score for head/neck + 0.3\*score for trunk + 0.2\*score for upper extremities + 0.4\*score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD. EASI 75 response was defined as at least a 75% reduction in EASI relative to baseline.
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) at Month 3
时间窗: At Month 3
The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.
次要结局
- Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study(From Baseline (Day 1) up to end of study (Month 12))
- Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study(From Baseline (Day 1) up to end of study (Month 12))
- Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) and a Reduction of >= 2 Points From Baseline Until End of Study(From Baseline (Day 1) up to end of study (Month 12))
- Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study(From Baseline (Day 1) up to end of study (Month 12))
- Percentage Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in Medical Outcomes Study Sleep (MOS) Scale at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Absolute EASI Total Score at Months 1, 3, 6, 9 and 12(At Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in EASI Total Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Absolute Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage of Participants Who Achieved at Least 4 Point Improvement on Pruritus Numerical Rating Scale (NRS) From Baseline Until End of Study(From Baseline (Day 1) up to end of study (Month 12))
- Percentage of Participants With Pruritus NRS Score Less Than or Equal to (<=1)(From Baseline (Day 1) up to end of study (Month 12))
- Percentage Change From Baseline in Peak-Pruritus (PP) NRS at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in Dermatology Life Quality-Index (DLQI) Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Percentage Change From Baseline in EuroQol Five-dimensional-five Level (EQ-5D-5L) Score at Months 1, 3, 6, 9 and 12(Baseline (Day 1), Months 1, 3, 6, 9 and 12)
- Treatment Satisfaction Measured by Patient Benefit Index (PBI) at Months 1, 3, 6, 9 and 12(At Months 1, 3, 6, 9 and 12)
- Number of Participants With Treatment Expectation Measured by PBI at Baseline(At Baseline (Day 1))
- Number of Days With Topical Treatment Use(Months 1, 3, 6, 9 and 12)
- Number of Days of Emollients Use(Months 1, 3, 6, 9 and 12)