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Omalizumab seen safe, effective in children 6 to 11 years

Reuters Health • The Doctor's Channel Daily Newscast

NEW YORK (Reuters Health) – In children aged 6 to 11 years with inadequately controlled allergic asthma, adding the anti-IgE monoclonal antibody omalizumab (Xolair; Novartis) to optimized treatment leads to a clinically significant reduction in asthma attacks and is well tolerated.

Those findings come from a double-blind randomized phase III study reported at the American College of Allergy, Asthma and Immunology annual meeting in Seattle, Washington.

“This study shows that adding omalizumab to existing therapy improves asthma control in children with severe allergic asthma, without the addition of lots of other medications, particularly steroids,” Dr. Bob Lanier from University of North Texas in Fort Worth, who was involved in the study, noted in a telephone interview with Reuters Health.

Omalizumab is currently approved for use in adults and adolescents aged 12 and older with moderate to severe persistent asthma. It is currently under review at the US Food and Drug Administration for use in children ages 6 to 11.

At the meeting, study co-author Dr. Tracy Bridges, of the Georgia Pollens Research Center, Albany, Georgia presented efficacy data for 384 omalizumab-treated and 192 placebo-treated children with persistent moderate or severe allergic asthma despite inhaled corticosteroid therapy (fluticasone 200 micrograms or more per day or equivalent).

The children received omalizumab by subcutaneous injection every 2 or 4 weeks in doses ranging from 75 to 375 mg, or matching placebo.

After 24 weeks, omalizumab reduced the rate of clinically significant asthma exacerbations during fixed-dose inhaled corticosteroid therapy by 31% versus placebo. Over the 52-week period, rates of clinically significant asthma exacerbations were reduced by 43% with omalizumab versus placebo.

Adverse events were similar between groups, most commonly nasopharyngitis, sinusitis and urinary tract infection. Most adverse events (91%) were characterized as mild or moderate. Two children in the omalizumab arm withdrew due to headache or bronchitis.

Summing up, Dr. Lanier said: “We know that steroids are negative when taken chronically, they probably accumulate over a period of time and allergic kids are taking steroids from every angle — taking some in the nose, inhaling some, putting some on the skin — so the aggregate load of steroids in these children is just huge. Omalizumab affects the basic disease process instead of just controlling symptoms.”