SAN FRANCISCO--The anti–immunoglobulin E (anti-IgE) monoclonal antibody omalizumab (previously known as rhuMAb-E25) not only improves clinical end points in the treatment of asthma but also is rated highly by physicians and patients alike in their global evaluation of treatment effectiveness, according to data from a phase III study presented at the annual meeting of the American College of Chest Physicians.[1]

At the end of 1999, Milgrom et al[2] published findings from a phase II trial that suggested that omalizumab was effective in the treatment of moderate–to–severe allergic asthma. The drug produced a significant improvement in asthma symptom scores and a decrease in the need for inhaled corticosteroids. In a study published last year, Adelroth et al[3] showed that omalizumab effectively controlled birch pollen–induced seasonal allergic rhinitis symptoms. The drug lowered the need for rescue antihistamines and other rhinitis medications and improved patients’ quality of life.

In the present study, Jeffrey P. Tillinghast, MD, examined data from a randomized, double–blind, placebo–controlled multicenter trial involving 546 patients with moderate–to–severe allergic asthma. At baseline, the patients had a forced expiratory volume in one second of between 40% and 80% of predicted. In addition, the mean daily dose of beclomethasone in the overall group was approximately 750 µg. At seven months, the patients were asked to rate their asthma control using the following scale:

Excellent: complete control of asthma.

Good: marked improvement of asthma.

Moderate: discernible but limited improvement in asthma.

Poor: no appreciable change in asthma.

Worse: worsening of asthma.

GOOD OR EXCELLENT ASTHMA CONTROL

Asthma control was rated as good or excellent by approximately 70% of patients randomized to receive anti–IgE treatment. Only 42.6% of patients in the placebo group reported good–to–excellent asthma control. This difference was statistically significant.

The patients’ physicians rated the patients’ asthma control on the same scale. They reported that about 66% of patients taking anti–IgE had either good or excellent control, compared with 34.8% of the placebo group, said Dr. Tillinghast, an Associate Professor of Medicine in the Department of Allergy and Immunology at Washington University, in St. Louis.

“This assessment provides excellent supporting evidence that omalizumab has the ability to improve symptoms, and [these improvements] correlate with the improvement in clinical efficacy that has been noted,” said Dr. Tillinghast, who is also Co-director of the Clinical Research Center at Barnes–Jewish–West County Hospital, in St. Louis.

--Kristin Della Volpe

References
1. Tillinghast JP. Physician and patient global evaluation of an anti–IgE antibody in patients with moderate–to–severe asthma. Paper presented at: CHEST 2000; October 24, 2000; San Francisco.

2. Milgrom H, Fick RB Jr, Su JQ, et al. Treatment of allergic asthma with monoclonal anti–IgE antibody. rhuMAb–E25 Study Group. N Engl J Med. 1999;341:1966– 1973.

3. Adelroth E, Rak S, Haahtela T, et al. Recombinant humanized mAb–E25, an anti–IgE mAb, in birch pollen–induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2000;106:253-259.

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