Omalizumab Said Safe, Effective for Children with Asthma

Omalizumab Said Safe, Effective for Children with Asthma

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Omalizumab Said Safe, Effective for Children with Asthma


SEATTLE—New findings indicate that treatment with the investigational compound omalizumab (Xolair) decreases the need for inhaled steroids in children with allergic asthma and also reduces the frequency of asthma exacerbations.

Omalizumab is anti-immunoglobulin E (IgE) humanized monoclonal antibody.

Results of the findings were presented here earlier this month at the annual meeting of the American College of Allergy, Asthma, and Immunology by Dr. William Berger, clinical professor in the Department of Pediatrics, Division of Allergy and Immunology, at the University of California-Irvine.

The clinical trial enrolled 334 patients from six to 12 years of age with moderate to severe allergic asthma. Participants were asymptomatic but required standard asthma therapy. Subjects were treated every two to four weeks for 28 weeks with subcutaneous omalizumab or placebo.

Cutting Cordicosteroids
After 16 weeks of stable inhaled corticosteroid treatment (steroid-stable phase), inhaled corticosteroid doses were reduced over eight weeks and then maintained at a constant rate for four weeks (steroid-reduction phase). In the trial, omalizumab dosing was based on the patient’s body weight and serum IgE level. Overall, 225 patients received the study drug and 109 received placebo.

Omalizumab and placebo groups were well-matched with respect to mean BDP demographic and clinical characteristics.

Results of the study showed 55 percent of omalizumab patients completely withdrew from steroid therapy compared with 39 percent of placebo patients. In addition, the mean number of exacerbations per patient was reduced in the omalizumab group compared with the placebo group during both the stable-steroid and steroid-reduction phases. That is, 15.6 percent of omalizumab patients developed one or more asthma exacerbations during the steroid-stable phase versus 22.9 percent of placebo patients.

During the steroid-reduction phase, 18.2 percent of omalizumab patients developed one or more asthma exacerbations compared with 38.5 percent of placebo patients.

As expected, because of patients’ asymptomatic status at baseline, there were no significant differences in the two treatment groups with respect to beta 2-agonist use, lung function and quality of life during the steroid-stable phase. However, the active treatment was statistically superior to placebo with respect to changes from baseline in activities and symptom domains and overall quality of life measures at the end of the steroid-reduction phase.

Safety Profile
Anti-IgE treatment had a safety profile similar to that of placebo. Serious adverse events other than asthma exacerbations were reported in four anti-IgE patients and four placebo patients; however, none of the events was judged to be drug-related by the investigators.

Elsewhere at the meeting, Berger described the results of a phase III study of subcutaneous omalizumab in 525 patients from 12 to 75 years of age with moderate to severe asthma who remained symptomatic despite daily treatment with inhaled corticosteroids.

As in the pediatric trial, the percentage of anti-IgE patients experiencing asthma exacerbations was reduced in both the steroid-stable and steroid-reduction periods.

Omalizumab is the first in a new class of compounds that works by inhibiting IgE, a key mediator of the allergic response. It binds to free circulating IgE and prevents it from interacting with its cellular receptors. The compound’s therapeutic efficacy results from the marked reduction in levels of free IgE and downregulation of cellular IgE receptors.

Jill Stein is a Paris-based freelance writer.

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