20111024健康相关生命质量HRQoL.pdf

健康相关生命质量及测量 Health Related Quality of Life(HRQoL) 蒋虹丽 博士, 讲师 jianghl@ Quality of Life? 2 Example: 阿达木单抗(修美乐) • Background: Humira, launched by Abbott in February 2003, is indicated for reducing the signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more disease- modifying antirheumatic drugs. • Value Opportunity: Abbott recognized patients as a key customer segment and their lifestyle needs as a key opportunity for Humira to demonstrate value. Specifically, they wanted to address patients ’ability to perform normal tasks such as grooming and walking. In addition to HRQL, the ability to dress/groom, arise, eat, walk, grip, maintain hygienen and daily activities were selected as end-points. The Health Assessment Questionnaire (HAQ) disability index and Short Form 36-item Health Survey physician component summary scores (SF-36) were selected as the instruments to measure the desired endpoints in a 52-week pivotal phase III study. The HAQ disability index captures patients’assessment of activities of daily living such as grooming, dressing, and walking. In the study, patients receiving Humira 40 mg every other week in combination with methotrexate, had a 0.59 mean change from baseline compared to a 0.25 change from baseline for patients receiving placebo plus MTX. The difference between Humira and placebo was statistically significant. The SF-36 measures general QOL. There are two component scores: physical health, which tracks physical functioning, bodily pain, and general health; and mental health