Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 506
- 试验地点
- 73
- 主要终点
- Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
研究概览
简要总结
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.
The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.
详细描述
This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.
Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).
As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index [PASI]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.
研究设计
- 研究类型
- Observational
- 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
- 否
入选标准
- •Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
- •Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
- •Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
- •Adult (≥18 years of age)
- •Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
- •Willing to provide informed consent if requested by the local law regulations
排除标准
- •Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
- •Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
- •Participate in another clinical/observational study
结局指标
主要结局
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
时间窗: Baseline and Month 12
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
时间窗: Baseline and Month 12
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI)(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving Complete Clearing of Nails(Months 3, 6, 9, and 12)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI)(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving Good Clinical Response on Scalp(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving Complete Clearing of Scalp(Months 3, 6, 9, and 12)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(Baseline and Month 12)
- Change From Baseline in PASI Score(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving a PASI 90 Response(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving a PASI 75 Response(Baseline and Months 3, 6, 9, and 12)
- Percentage of Participants Achieving a PASI 50 Response(Baseline and Months 3, 6, 9, and 12)
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline and Month 12)
- Change From Baseline in DLQI Score(Baseline and Months 3, 6, 9, and 12)
- Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis(Baseline and Month 12)
- Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis(Baseline and Month 12)
- Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis(Baseline and Month 12)
- Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis(Baseline and Month 12)
- Associations Between General Improvement in Psoriasis With Improvement in Quality of Life(Baseline and Month 12)