PURPOSE: Omalizumab is a recombinant humanized monoclonal anti-IgE antibody approved for the treatment of 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 2500 non-omalizumab-treated patients aged ≥12 years. This analysis evaluated the impact of omalizumab treatment on concomitant medication use (total ICS dose [including monotherapy and combination-therapy, fluticasone equivalent], short-acting beta agonists [SABA], and leukotriene receptor antagonists [LTRA]) over 2 years among subsets of patients enrolled in EXCELS.
METHODS: Patient subsets included “new starts” who initiated omalizumab at baseline (n=549), “established users” who were treated with omalizumab >7 days before baseline (n=4421), and “non-omalizumab” who were not treated with omalizumab (n=2867).
RESULTS: At baseline, mean (± SD) total daily ICS doses were 680 (± 414) μg/d in new starts, 642 (± 431) μg/d in established users, and 548 (± 382) μg/d in non-omalizumab patients. From baseline through Year 2, total ICS dose decreased in 65% of new starts (mean ± SD change, -393 ± 504 μg/d), 57% of established users (-287 ± 492 μg/d), and 54% of non-omalizumab patients (-232 ± 431 μg/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, LTRA dose decreased in 52% of new starts, 44% of established users, and 40% of non-omalizumab patients.
CONCLUSIONS: Initiation of omalizumab therapy was associated with decreased doses of ICS, SABA, and LTRA over 2 years of follow-up for the majority of patients in a “real-world” cohort study of patients with moderate-to-severe allergic asthma.
CLINICAL IMPLICATIONS: In addition to its established efficacy in controlled clinical trials, omalizumab appears to have additional clinical benefit in reducing concomitant asthma therapy.
DISCLOSURE: Ashley Yegin: Employee: Genentech, Inc.
Mark Eisner: Employee: Genentech, Inc.
Ben Trzaskoma: Employee: Genentech, Inc.
Hubert Chen: Consultant fee, speaker bureau, advisory committee, etc.: Advisory Board Member for Genentech
No Product/Research Disclosure Information