Dec. 23, 1999 EMBARGOED UNTIL: December 22, 1999, 5 p.m. EST
DENVER-Some people with allergic asthma can experience improvement in their symptoms even as they reduce or completely eliminate the need for oral or inhaled corticosteroids by using anti-IgE, according to today’s issue of the New England Journal of Medicine.
“This is a completely new approach to therapy, one that may greatly improve the treatment outlook for people with allergic asthma. It’s unlike anything that’s been used before,” said Henry Milgrom, M.D., lead author of the article and a pediatric asthma specialist at National Jewish Medical and Research Center. The study information published in the New England Journal of Medicine is the result of Phase II clinical trials. Thirty-three percent of patients in the high dose anti-IgE group and 43 percent in the low dose group completely eliminated the use of oral corticosteroids, which come in syrup and pill form. Seventeen percent taking the placebo stopped using oral corticosteroids, as well. (Researchers believe that patient education throughout the study encouraged better self-management of asthma, leading to the drop in medication use in the placebo groups.)
“Oral corticosteroids suppress the swelling and inflammation of the airways that are responsible for asthma symptoms. These drugs have serious long term side-effects, such as osteoporosis, high blood pressure, cataracts and, in children, slowed growth. The ability to eliminate or reduce the need for this medicine would be a very favorable development in the treatment of allergic asthma,” Dr. Milgrom said. Anti-IgE medication has minimal side effects. “Anti-IgE therapy may reduce steroid use in some patients and eliminate it in others,” he added.
Dr. Milgrom and other researchers around the United States were involved in a multi-center study of more than 300 adolescents and adults with moderate to severe allergic asthma. All patients used inhaled and/or oral corticosteroids to control the disease, which can be triggered by allergies to pollen, animal dander, mold or dust mites.
Patients received a high or low dose of anti-IgE, or placebo throughout the study. During the first 12 weeks, patients took anti-IgE or a placebo as well as their inhaled and/or oral corticosteroids. For the next eight weeks patients continued to take anti-IgE or placebo while they were weaned from corticosteroids.
IgE, an antibody in the immune system, causes allergic symptoms by attaching to certain cells in the body. When these cells come in contact with an allergen, a substance to which an allergy sufferer is sensitive, allergic symptoms such as coughing, wheezing, nasal congestion, hives and swelling begin. Anti-IgE binds IgE and removes it from circulation. In the study, IgE in patients’ blood was reduced by more than 95 percent. IgE was discovered by National Jewish researchers in 1966.
Symptoms, such as chest tightness, wheezing or excessive coughing, improved by 42 percent in people receiving high and 40 percent in those on low doses of anti-IgE. In people receiving the placebo, asthma symptoms improved by 30 percent.
For those using oral corticosteroids, 78 percent on high dose anti-IgE and 57 percent on low dose were able to reduce corticosteroid use by more than 50 percent. Thirty-three percent on placebo had a 50 percent reduction in oral corticosteroid use.
In addition to a reduced requirement for corticosteroids, patients had markedly improved scores on quality-of-life questionnaires that assessed their activities, asthma symptoms, emotional functioning, and symptoms induced by environmental exposures.
Anti-IgE is being developed jointly by Genentech, Inc., Novartis Pharma AG and Tanox, Inc. The companies are collaborating in the evaluation of the safety and efficacy of this drug in the therapy of asthma and seasonal allergic rhinitis. Regulatory files for the drug are expected in both the U.S. and Europe by mid-year 2000.
For more information about asthma treatment, call National Jewish’s LUNG LINE, 800-222-LUNG or e-mail, firstname.lastname@example.org. Questions will be answered by registered nurses.
The Number 1 Respiratory Hospital in the U.S. for Two Consecutive Years, U.S. News & World Report, 1998-2000.
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