Concomitant asthma medications in moderate-to-severe allergic asthma treated with omalizumab

Background: Omalizumab is a recombinant humanized monoclonal anti-IgE antibody approved in adults and adolescents with moderate-to-severe persistent allergic asthma inadequately controlled with inhaled corticosteroids (ICS). EXCELS is an ongoing prospective observational cohort study of approximately 5000 omalizumab-treated and >2800 non-omalizumab-treated patients aged >= 12 years. Objective: We evaluated concomitant medication use changes (total ICS dose [including mono-therapy and combination therapy, fluticasone equivalent], short-acting beta-agonists [SABA], and leukotriene modifier [LTM]) over 2 years among subsets of patients enrolled in EXCELS. Methods: Patient subsets included new starts (omalizumab initiated at baseline [n = 549], established users (omalizumab initiated >7 days before baseline [n = 4421]), and non-omalizumab patients (not treated with omalizumab [n = 2867]). Results: At baseline, mean +/- SD total daily ICS doses were 680 +/- 414 mu g/d in new starts, 642 +/- 431 mu g/d in established users, and 548 +/- 382 mu g/d in non-omalizumab patients. From baseline through year 2, total ICS dose decreased in 65% of new starts (mean +/- SD change, -393 +/- 504 mu g/d), 57% of established users (-287 +/- 492 mu g/d), and 54% of non-omalizumab patients (-232 +/- 431 mu g/d). At baseline, SABA use for new starts, established users, and non-omalizumab patients was 1.9, 1.3, and 1.4 puffs/d, respectively. At year 2, SABA use decreased in 65% of new starts, 55% of established users, and 54% of non-omalizumab patients. At year 2, LTM dose decreased in 52% of new starts, 44% of established users, and 40% of non-omalizumab patients. Conclusion: Omalizumab therapy initiation was associated with decreased doses of ICS, SABA, and LTM over 2 years of follow-up for the majority of patients in a real-world cohort study of moderate-to-severe allergic asthma patients. (c) 2012 Elsevier Ltd. All rights reserved.