PURPOSE:Uncontrolled asthma adversely affects patient's activities of daily living. NAEPP guidelines recommend assessing impairment from asthma using a number of measures (ability to maintain normal activity level, symptoms, rescue medication use, lung function and patient reported outcomes). We describe the effect of omalizumab (OMA) on measures of impairment in patients with moderate-severe persistent asthma inadequately controlled with inhaled corticosteroids.
METHODS:Data were pooled from 5 randomized, double-blind, 28–32 week, placebo (PBO)-controlled OMA asthma studies (total n=2236). Patients had to be allergic to one or more common perennial aeroallergens and have a serum IgE 30–700 IU/mL. Impairment was defined as a Juniper Adult Asthma Quality of Life Questionnaire (AQLQ) overall score < 5.5 at study entry. The effect of OMA on impairment was assessed by changes in AQLQ (total and activities domain scores), total asthma symptom scores, changes in lung function (FEV1) and number of rescue puffs of beta agonist. Changes in AQLQ, symptoms, FEV1 and rescue puffs were analyzed using analysis of covariance; least squares means (LSM) and 95% confidence intervals (CI) were calculated.
RESULTS:1939 patients (994 OMA, 945 PBO) met the definition for impairment. The addition of OMA improved AQLQ total scores [LSM OMA 1.04,PBO 0.70, LSM diff 0.34 (CI 0.25,0.44) p<0.0001], AQLQ activity scores [LSM OMA 1.06, PBO 0.73; LSM diff 0.33 (CI 0.23,0.43) p<0.0001] and total asthma symptom scores [LSM OMA -1.18, PBO -0.78; LSM diff -0.39 (CI -0.54,-0.25) p<0.0001]. OMA patients had greater improvement in FEV1 [LSM OMA 123 ml, PBO 48 ml; LSM diff 75.3 ml (CI 42.1,108.5) p<0.0001] and required fewer puffs of rescue beta agonist [LSM OMA -1.19, PBO -0.59, LSM diff -0.60 (CI -0.84,-0.36) p<0.0001].
CONCLUSION:Addition of omalizumab reduced impairment from moderate-severe persistent asthma in patients inadequately controlled with inhaled corticosteroids.
CLINICAL IMPLICATIONS:Asthma can be improved by identifying impairment from persistent moderate-severe disease and adjusting therapy accordingly.
DISCLOSURE:Marc Massanari, Shareholder Stockholder of Novartis; Employee Employee of Novartis; No Product/Research Disclosure Information