Â鶹´«Ã½

Novel Anti-IgE Therapy Reduces Allergy Symptoms, Asthma Flare-ups and the Need to Use Some Medications

ARLINGTON HEIGHTS, Ill. (Feb. 25, 2002) -- Monoclonal anti-IgE antibody, a novel therapy for asthma and other allergic diseases, has been shown to improve the quality of life for patients by reducing allergy symptoms, asthma flare ups and the need to use some medications according to a review published in Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).

"This promising new therapy known as anti-IgE is still undergoing clinical trials and has not yet been approved by the Food and Drug Administration," said investigator William E. Berger, M.D., MBA, Southern California Research, Mission Viejo, Calif. "Omalizumab is the first clinical anti-IgE agent selected from a series of humanized antibodies as the candidate anti-IgE for further study. Published data for preclinical and clinical studies suggest it is safe and well tolerated."

According to Dr. Berger, the anti-IgE medication is a recombinant human monoclonal antibody (rhuMab) administered by subcutaneous (under the skin) injection. Researchers have designed the drug to block IgE before it can bind to the mast cell, thereby interrupting the trigger that releases inflammatory mediators, such as histamine, which cause the symptoms associated with allergic reactions.

"This blockade, which occurs at such an early and central point in the process of inflammation, is a departure from previous pharmacological approaches that focus on symptom relief. Since anti-IgE therapy is not allergen-specific, it is an important new development in the treatment of allergic disease," Dr. Berger said.

"When compared to placebo, anti-IgE reduced exacerbations in patients with moderate to severe allergic asthma, and at the same time, allowed inhaled corticosteroids to be reduced or withdrawn. In patients with allergic rhinitis, anti-IgE reduced the severity of symptoms and rescue antihistamine usage," he said.

In the review article, Dr. Berger also identified other groups of patients who might benefit from anti-IgE therapy. These include patients who adhere poorly to a daily inhaled or oral medication regimen; those who have multiple unrelated allergen sensitizations or severe allergic disease; patients with atopic dermatitis that is difficult to manage; those who are allergic to a food or food additive that is difficult to avoid; and patients who are allergic to latex. Anti-IgE therapy has not been studied in all of these groups, and its efficacy has not been studied in cases of non-allergic asthma and rhinitis.

Anti-IgE therapy has potential application for use in conjunction with specific immunotherapy, and has been shown to provide significant additional reduction in symptoms for patients allergic to grass pollen.

"Studies in humans have shown that once omalizumab is stopped, IgE levels gradually return to baseline," said investigator Thomas B. Casale, M.D., Creighton University, Omaha, Neb. "There have not been studies documenting a long lasting immunodulatory effect of omalizumab therapy once the therapy is stopped. In contrast, traditional allergen immunotherapy has many long-lasting effects."

"It would make sense to combine these two therapies in an attempt to provide a better therapeutic option to patients with allergic rhinitis and asthma. The combination should reduce symptoms and improve patient's outcomes to a greater degree than either therapy alone," he said.

Administration of anti-IgE therapy may lower the risk for patients who are currently not good candidates for traditional allergen immunotherapy due to their severe reaction to a specific allergen, according to Dr. Casale.

In the clinical trials for allergic asthma and seasonal allergic rhinitis, injections were administered every two-to-four weeks, depending on the patient's body weight and IgE level. Treatment was initiated prior to the start of pollen season for seasonal allergic rhinitis.

"Additional research into the different types of allergic diseases that can be treated with anti-IgE, and further research into the mechanism of its action will need to be done. But for the present, the clinical results with anti-IgE confirm its important role in both allergic rhinitis and allergic asthma," Dr. Berger said.

The American College of Allergy, Asthma and Immunology is a professional medical organization comprised of 4,200 qualified allergists-immunologists and related health care professionals. The ACAAI is dedicated to the clinical practice of allergy, asthma and immunology through education and research to promote the highest quality of patient care.

###

Note to reporters: Free online access to full-text articles in Annals of Allergy, Asthma & Immunology is available to working press. E-mail ACAAI at [email protected] for login codes.

Citation: Berger WE. Monoclonal anti-IgE antibody: a novel therapy for allergic airways disease. Ann Allergy Asthma Immunol 2002; 88:152-161.