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Benefit From Omalizumab Seen Across IgE Levels in Patients With Severe Allergic Asthma: Presented at ERS

By Paula Moyer

MUNICH, GERMANY -- September 13, 2006 -- Patients with severe asthma that has an allergic component seem to benefit from omalizumab (Xolair) across a variety of baseline immunoglobulin E (IgE) levels, according to investigators speaking here at the 16^th annual meeting of the European Respiratory Society (ERS).

"We saw a marked reduction in exacerbation rates in responding patients irrespective of baseline IgE," said principal investigator Stephen Holgate, MD, Medical Research Council clinical professor of immunopharmacology, University of Southampton, Southampton, United Kingdom.

"It might enhance patient selection if physicians assess treatment response after 16 weeks of omalizumab therapy," Dr. Holgate added.

The 16-weeks assessment is required by the European Union labeling, he said during the presentation on September 5^th.

To identify ways of predicting which asthma patients would benefit from treatment with omalizumab, Dr. Holgate and colleagues assessed pre-treatment clinical and disease characteristics among patients who had participated in a randomized clinical trial. The researchers also conducted a confirmatory analysis on pooled data drawn from 7 clinical trials. In all, the investigators analyzed data on more than 5,000 patients randomized to omalizumab or placebo.

The investigators also reviewed randomized clinical trial data to determine the accuracy of the methods used to evaluate patients' clinical responses. Specifically, they wanted to evaluate the efficacy of methods used to differentiate exacerbation outcomes in responders and nonresponders.

The researchers grouped IgE levels by quartiles (0-75 IU/mL, 76-147 IU/mL, 148-273, IU/mL, and 274 IU/mL or greater). They defined treatment response as at least a marked improvement in asthma control.

Physician assessments showed that 61% of patients were responders.

Results showed that subjects' total baseline IgE level was the only variable that predicted responders to omalizumab in the clinical trial. However, when they analyzed the pooled data based on patients' baseline IgE, they found that a meaningful treatment benefit occurred at all IgE levels.

Responders were less likely to require hospitalization, with 2.5% of responders hospitalized for asthma versus 9.1% of nonresponders. Responders were also less likely to require emergency visits, unscheduled physician visits, and any unscheduled healthcare utilization.

The researchers also found that responders had fewer night awakenings due to asthma, had a greater reduction in the number of daily puffs of rescue medication, and higher increases in forced expiratory volume in 1 second.

Based on their findings, the investigators concluded that the best way to identify responders among patients with severe allergic asthma is to administer omalizumab and follow them closely to see if asthma symptoms markedly improve.


[Presentation title: Add-on Omalizumab Therapy for Patients With Severe Persistent Allergic (IgE-Mediated) Asthma: Identifying Which Patients to Treat and Which Patients Respond. Abstract P2564]

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