ABSTRACT
OBJECTIVES: To compare the impact of ankylosing spondylitis (AS) on health-related quality of life (HRQL) and of adalimumab on initial and sustained improvement in HRQL for patients with active AS versus the general US population. METHODS: Data from the 5-year ATLAS trial were analysed. HRQL burden of AS and treatment impact on HRQL were assessed by comparing health status and utility scores from ATLAS (Short Form 36 Health Survey [SF-36] and Health Utilities Index Mark 3 [HUI3]) with population norms. RESULTS: Baseline scores for all measures were comparable between adalimumab and placebo. All scores for both groups were significantly worse than general population norms (all p<0.0001). Within- and between-group improvements in SF-36 Physical Component Summary and SF-6D scores from baseline to Weeks 12 and 24 were clinically relevant for patients receiving adalimumab. For patients initially randomised to adalimumab, HRQL scores improved from Weeks 25 to 52 and remained relatively stable through 3 years but remained lower than for the general US population at all time points. CONCLUSIONS: Findings demonstrate a significant burden of AS on HRQL. Treatment with adalimumab significantly improved physical functioning and other measures of HRQL compared with placebo. Clinically relevant improvements in HRQL outcomes over 3 years represent a significant benefit of adalimumab. Because of the advanced AS disease, patient health status remained below that of the general population. Treatment earlier in the course of AS may be needed to restore HRQL to the level of the general population.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Quality of Life , Spondylitis, Ankylosing/drug therapy , Adalimumab , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized , Cost of Illness , Disability Evaluation , Double-Blind Method , Female , Health Status , Health Status Indicators , Health Surveys , Humans , Male , Middle Aged , Recovery of Function , Spondylitis, Ankylosing/diagnosis , Spondylitis, Ankylosing/physiopathology , Spondylitis, Ankylosing/psychology , Surveys and Questionnaires , Time Factors , Treatment Outcome , United States , Young AdultABSTRACT
This study was aimed to evaluate in clinical trial settings the psychometric properties of the revised Patient Perception of Migraine Questionnaire (PPMQ-R), a satisfaction measure for acute migraine treatment. The PPMQ-R was administered 24 h post dosing in 1304 migraineurs randomized to two identical Phase 3, single-attack trials. Reliability, concurrent and construct validity and known-groups validity were evaluated using Cronbach's alpha, Pearson correlations and analysis of variance, respectively. PPMQ-R scale and Total scores (Efficacy, Functionality and Ease of use) showed very good internal consistency reliability (alpha 0.84-0.99). Efficacy, Functionality and Total PPMQ-R scores showed large, inverse relationships with migraine pain severity, number of migraine symptoms and work ability (r = -0.62 to -0.75; all P < 0.0001). All scales discriminated among migraine pain severity levels (all P < 0.001). The PPMQ-R has sufficient evidence of validity and reliability for measuring patient satisfaction, an important benchmark of quality and effective care.
