A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- Dermatology Life Quality Index (DLQI) Scores
研究概览
简要总结
The impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease. Data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation. Given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians. This study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.
详细描述
This was a multi-center, prospective, post-marketing observational study of participants with severe chronic plaque psoriasis who began adalimumab therapy in the United Kingdom. Although 153 participants enrolled in the study, data was only analyzed on 143 individuals and there were no interventions or changes to participant management for the study. Prior to initiating adalimumab therapy (baseline), the Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area Severity Index (SAPASI), Hospital Anxiety and Depression Scale (HADS), Cutaneous Body Image (CBI) scale, Short Form 12 (SF-12) Health Survey, Female Sexual Function Index (FSFI) (female participants) and International Index of Erectile Function (IIEF) (male participants) questionnaires were completed by participants and at 4 weeks, 16 weeks and 6 months following initiation.
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
- 否
入选标准
- •Participants were eligible for adalimumab as determined by the National Institute for Health and Clinical Excellence (NICE) criteria
- •Participants had severe psoriasis as defined by a Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10
- •Participant's psoriasis did not respond to standard systemic therapies, to include: ciclosporin, methotrexate, and psoralen and long-wave ultraviolet radiation; or the participant was intolerant of or had a contraindication to these treatments
排除标准
- •Participants were previously treated with another biologic therapy
- •Participants were unable or unwilling to complete the study questionnaires
结局指标
主要结局
Dermatology Life Quality Index (DLQI) Scores
时间窗: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation.
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline
时间窗: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. "Responders" to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.
次要结局
- Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline(4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Cutaneous Body Image Scale (CBI) Scores(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Female Sexual Function Index (FSFI) Score(Baseline; 16 weeks, and 6 months following adalimumab initiation)
- Mean Change in Female Sexual Function Index (FSFI) Score From Baseline(4 week, 16 weeks, and 6 months following adalimumab initiation)
- International Index of Erectile Function Score(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline(4 weeks, 16 weeks, and 6 months after adalimumab initiation)
- Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline(4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline(4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Psoriasis Area and Severity Index (PASI) Scores(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Hospital Anxiety and Depression Scale (HADS) Scores(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- 12-item Short Form Survey (SF-12) Score(Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation)
- Change in 12-item Short Form Survey (SF-12) Score From Baseline(4 weeks, 16 weeks, and 6 months following adalimumab initiation)