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 monotherapy 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 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, LTM dose decreased in 52% of new starts, 44% of established users, and 40% of non-omalizumab patients.


CONCLUSIONS
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.
Genentech, Inc., South San Francisco, CA, USA. chen.hubert@gene.com
Hubert
H
Chen
Mark D
MD
Eisner
Tmirah
T
Haselkorn
Benjamin
B
Trzaskoma
D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011446:Prospective Studies; D055815:Young Adult
D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D020024:Leukotriene Antagonists; D000069444:Omalizumab