Prs58 Mepolizumab Induced Myalgia: A Disproportionality Analysis in Usfda Adverse Event Reporting System Database

Abstract

Objectives: Asthma causes impairments in health-related quality of life (HRQL). The widely used generic HRQL tool, the EQ-5D-5L, is used to evaluate interventions improving HRQL. However, there is not enough information about its suitability in the asthma population. Methods: Data stems from the randomized controlled trial EPRA, offering pulmonary rehabilitation (PR) for the intervention group. We measured HRQL for 371 patients at four time points according to the intervention group: T0 (randomization), T1 (start of PR), T2 (end of PR), and T3 (three months after PR). We measured the generic EQ-5D-5L (utilities and the Visual Analog Scale (VAS)) and the disease specific Asthma Quality of Life Questionnaire (AQLQ). We calculated intraclass correlation (T0-T1), Cohen's d (T2, T3) and regression analysis to evaluate the responsiveness to changes in asthma control, measured with Asthma Control Test (ACT). Results: ICC was 0.82, 0.72 and 0.74 for AQLQ, utilities and VAS respectively. All HRQL tools could differentiate better between well-controlled asthma versus not wellcontrolled asthma, than between not well-controlled asthma and very poorly controlled asthma. AQLQ showed the highest Cohen's d in almost every case. ACT changes were detected by VAS in every period. AQLQ was more responsive for positive changes while the utilities did not appropriately react to changes. Conclusions: The utilities have difficulties to detect changes due to a change in asthma control. This could modify results of health economic evaluations. Therefore, we suggest the use of additional measures (e.g. AQLQ) to provide a comparison.