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Clinical Pediatrics
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Adding Omalizumab to the Therapy of Adolescents With Persistent Uncontrolled Moderate—Severe Allergic Asthma

M. Massanari, PharmD

Pharmaceuticals Corporation, East Hanover, New Jersey, marc.massanari{at}novartis.com

H. Milgrom, MD

National Jewish Health, Denver, Colorado

S. Pollard, MD

Family Allergy and Asthma, Louisville, Kentucky

R.J. Maykut, MD

Novartis International AG, Basel, Switzerland

Farid Kianifard, PhD

Pharmaceuticals Corporation, East Hanover, New Jersey

A. Fowler-Taylor

Novartis International AG, Basel, Switzerland

G.P. Geba, MD, MPH

Pharmaceuticals Corporation, East Hanover, New Jersey

R.K. Zeldin, MD

Pharmaceuticals Corporation, East Hanover, New Jersey

Objective. This study aimed to evaluate the effectiveness of omalizumab among adolescents with moderate—severe allergic asthma inadequately controlled with inhaled corticosteroids. Patients and 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. Conclusion. Omalizumab added to baseline therapy improves measures of asthma control in adolescents with persistent moderate—severe allergic asthma.

Key Words: asthma • adolescent • corticosteroids • omalizumab • inflammation

This version was published on October 1, 2009

Clinical Pediatrics, Vol. 48, No. 8, 859-865 (2009)
DOI: 10.1177/0009922809339054


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