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Seasonal Variability of Lung Function and Asthma Quality of Life Questionnaire Scores in Adults with Severe Asthma
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A1437 - Seasonal Variability of Lung Function and Asthma Quality of Life Questionnaire Scores in Adults with Severe Asthma
Author Block: D. Choy, X. Yang, T. Staton, J. K. Olsson, C. Holweg, J. R. Arron, J. G. Matthews, R. Bauer; Genentech, Inc, South San Francisco, CA, United States.
Background: Epidemiologic studies have implicated aeroallergens and respiratory infections as triggers underlying seasonal increases in asthma exacerbations in spring and autumn months. These seasonal factors may trigger or amplify airway inflammation in Type 2 high asthma patients that precipitate into increased exacerbation rates. We have previously described the seasonal variability of asthma exacerbations and treatment effectiveness of IL-13 blockade in adults with severe, uncontrolled asthma. The extent to which seasonal factors influence other asthma clinical endpoints such as lung function and patient reported outcomes is poorly studied. Herein, we hypothesized that airway associated outcomes vary by season, and specifically that patient outcomes would be more severe in the winter and milder in the summer.
Methods: We conducted post hoc analyses of LAVOLTA I and II studies (NCT01867125 and NCT01868061) comprising 2,148 severe, uncontrolled asthma patients that had been measured monthly over 52 weeks to assess the seasonal dependence of clinical outcomes, including lung function measurements (pre-bronchodilator FEV1, FVC, and peak expiratory flow) and Standardized Asthma Quality of Life Questionnaire {AQLQ(S)}. By-month estimates (normalized by hemispheric season) were based on mixed-effect models with repeated measures (MMRM), adjusted by study stratification factors as covariates when appropriate. The dependency of clinical outcomes with seasonal variability was assessed by employing linear contrasts comparing hemisphere normalized December versus July group means from an MMRM regression and presented as the difference in means (95% CI).
Results: Data for each outcome was available for at least 95% of each patient’s visits. The December versus July mean differences were: 1) Peak Expiratory Flow = -6.5 (-8.2, -4.7) L/min, 2) Pre-bronchodilator FEV1 = -42 (-53, -31) mL, 3) FVC = -41 (-55, -27) mL, and 4) AQLQ(S) = -0.15 (-0.18, -0.11) units. Among AQLQ questions, discomfort related to cough was most variable with respect to season {-0.33 (-0.39, -0.27) units} whereas experiencing asthma symptoms as a result of being exposed to strong smells or perfume had the least seasonal effect {-0.08 (-0.13, -0.03) units}.
Conclusion: Lung function and AQLQ outcomes varied with respect to season, albeit modestly; the seasonal dependence of individual AQLQ components varied by component, which could confound analyses of the overall score. While the observed seasonal differences may not be clinically meaningful, these data potentially provide insights into factors that underlie these outcomes and could lead to new therapeutic strategies and clinical study designs to better evaluate efficacy for asthma symptoms.
Author Block: D. Choy, X. Yang, T. Staton, J. K. Olsson, C. Holweg, J. R. Arron, J. G. Matthews, R. Bauer; Genentech, Inc, South San Francisco, CA, United States.
Background: Epidemiologic studies have implicated aeroallergens and respiratory infections as triggers underlying seasonal increases in asthma exacerbations in spring and autumn months. These seasonal factors may trigger or amplify airway inflammation in Type 2 high asthma patients that precipitate into increased exacerbation rates. We have previously described the seasonal variability of asthma exacerbations and treatment effectiveness of IL-13 blockade in adults with severe, uncontrolled asthma. The extent to which seasonal factors influence other asthma clinical endpoints such as lung function and patient reported outcomes is poorly studied. Herein, we hypothesized that airway associated outcomes vary by season, and specifically that patient outcomes would be more severe in the winter and milder in the summer.
Methods: We conducted post hoc analyses of LAVOLTA I and II studies (NCT01867125 and NCT01868061) comprising 2,148 severe, uncontrolled asthma patients that had been measured monthly over 52 weeks to assess the seasonal dependence of clinical outcomes, including lung function measurements (pre-bronchodilator FEV1, FVC, and peak expiratory flow) and Standardized Asthma Quality of Life Questionnaire {AQLQ(S)}. By-month estimates (normalized by hemispheric season) were based on mixed-effect models with repeated measures (MMRM), adjusted by study stratification factors as covariates when appropriate. The dependency of clinical outcomes with seasonal variability was assessed by employing linear contrasts comparing hemisphere normalized December versus July group means from an MMRM regression and presented as the difference in means (95% CI).
Results: Data for each outcome was available for at least 95% of each patient’s visits. The December versus July mean differences were: 1) Peak Expiratory Flow = -6.5 (-8.2, -4.7) L/min, 2) Pre-bronchodilator FEV1 = -42 (-53, -31) mL, 3) FVC = -41 (-55, -27) mL, and 4) AQLQ(S) = -0.15 (-0.18, -0.11) units. Among AQLQ questions, discomfort related to cough was most variable with respect to season {-0.33 (-0.39, -0.27) units} whereas experiencing asthma symptoms as a result of being exposed to strong smells or perfume had the least seasonal effect {-0.08 (-0.13, -0.03) units}.
Conclusion: Lung function and AQLQ outcomes varied with respect to season, albeit modestly; the seasonal dependence of individual AQLQ components varied by component, which could confound analyses of the overall score. While the observed seasonal differences may not be clinically meaningful, these data potentially provide insights into factors that underlie these outcomes and could lead to new therapeutic strategies and clinical study designs to better evaluate efficacy for asthma symptoms.
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