Efficacy of Etanercept in Iraqi Patients With Moderate to Severe Psoriasis: 5 Years Data From Local Registry.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
研究概览
简要总结
This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year.
- •Age ≥18 years old.
- •No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.
排除标准
- •Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration.
- •Previous use of other biological treatments for any reason
研究组 & 干预措施
Patients with moderate to severe plaque psoriasis
Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease.
干预措施: Enbrel (Drug)
结局指标
主要结局
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
时间窗: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Change From Baseline in Percent Body Surface Area (BSA) at Month 12
时间窗: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12
时间窗: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.
次要结局
- Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment(Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study))
- Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment(Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study))
- Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment(Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study))