Adding omalizumab to the therapy of adolescents with persistent uncontrolled moderate--severe allergic asthma.
OBJECTIVE
This study aimed to evaluate the effectiveness of omalizumab among adolescents with moderate-severe allergic asthma inadequately controlled with inhaled corticosteroids.


METHODS
Data from patients 12 to 17 years of age were pooled from 5 placebo-controlled registration trials of omalizumab. Impact on asthma control was assessed by need for rescue bursts of oral corticosteroids, lung function, symptom scores, and unscheduled office visits.


RESULTS
In adolescents (n = 146), addition of omalizumab decreased mean number of rescue bursts (0.3 vs 0.9) versus placebo; relative risk 0.47 (95% confidence interval [CI], 0.22-0.99; P = .047). At study conclusion, mean forced expiratory volume in 1 second increased 268 mL (13.8%) in omalizumab-treated subjects versus 98 mL (5.5%) for placebo (least squares mean treatment difference 146 mL [95% CI, 19.4-272.6; P = .024]). Omalizumab significantly improved asthma symptom scores and reduced unscheduled office visits.


CONCLUSIONS
Omalizumab added to baseline therapy improves measures of asthma control in adolescents with persistent moderate-severe allergic asthma.
Massanari
M
M
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936-1080, USA. marc.massanari@novartis.com
Milgrom
H
H
Pollard
S
S
Maykut
R J
RJ
Kianifard
Farid
F
Fowler-Taylor
A
A
Geba
G P
GP
Zeldin
R K
RK
D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D006967:Hypersensitivity / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D009819:Office Visits / Q000706:statistics & numerical data; D000069444:Omalizumab; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D000069444:Omalizumab