March 23, 2004 (San Francisco) — Omalizumab (Xolair), a monoclonal anti-IgE antibody, provided symptomatic relief and a better quality of life for patients who suffer from both allergic asthma and persistent allergic rhinitis, according to two studies presented here at the annual meeting of the American Academy of Allergy, Asthma & Immunology. Omalizumab received U.S. Food and Drug Administration approval in June 2003.
"For patients with concomitant allergic asthma and persistent allergic rhinitis, omalizumab is effective," said Ulf Harnest, MD, from ClinGuard GmbH Institute for Medical Treatment Strategies in Munich, Germany, during his presentation of the first study. "It is rated effective by patients, and most important, it is well-tolerated."
The researchers conducted a 28-week double-blind, placebo-controlled trial of 405 patients with both moderate to severe allergic asthma and persistent allergic rhinitis. The patients were between the ages of 12 and 74 years.
Patients were randomized to receive either treatment or placebo, in addition to conventional therapies of inhaled budesonide plus the option of a long-acting beta 2-agonist and nasal steroids.
In the omalizumab group, 209 patients were given 0.016 mg/kg/IgE (IU/mL) every four weeks, while 196 patients received placebo.
The first study's primary end points were the exacerbation of asthma, which was defined as having worsening symptoms requiring oral or intravenous steroids or a doubling of the budesonide dose, as well as worsening quality of life.
Secondary end points included clinical symptoms, patients' self-evaluation, and drug safety and tolerability.
The researchers used the Juniper asthma scale and rhinitis questionnaires to measure quality of life. Responders were considered those who showed improvement of more than 1 point on both scales.
Before treatment, there was no difference between the two groups' scores on their quality-of-life questionnaires. After treatment, 57.7% of those treated with omalizumab were responders compared with 40.6% of those who received placebo. Similarly, 65.6% of the omalizumab-treated patients rated control of their asthma symptoms as excellent/good compared with 53.1% of placebo-treated patients.
Nearly 17% of the patients receiving omalizumab experienced adverse events compared with 12% of those in the placebo group. Serious adverse effects were seen in 1.4% of the omalizumab group and 1.5% of the placebo group.
In the second study, researchers looked at efficacy as measured by number of exacerbations, a combined asthma and rhinitis clinical symptom score, and pulmonary function.
They found fewer exacerbations in patients treated with omalizumab, as well as a significant difference in mean morning pulmonary function at all assessments during treatment. The combined symptom score decreased by an adjusted average of 17.8 points for patients in the omalizumab groups compared with a 12.4 decrease for those receiving placebo.
Sami L. Bahna, MD, DrPH, professor of pediatrics and medicine and chief of allergy and immunology at the Louisiana State University Health Sciences Center in Shreveport, found the difference of 15% vs. 10% on FEV 1 not a robust finding. He was not involved in the studies.
"I was surprised that the study did not show a more favorable effect, as previous studies in asthma did," Dr. Bahna told Medscape, noting that less-expensive and easier-to-use drugs may have an equivalent effect.
AAAAI 60th Annual Meeting: Abstracts 602 and 48. Presented March 21-22, 2004.
The research was funded by Novartis Pharma AG and Genentech.
Reviewed by Gary D. Vogin, MD
Melissa Schorr is a freelance writer for Medscape.
Medscape Medical News © 2004
Cite this: Omalizumab Improves Quality of Life for Asthma and Rhinitis Patients - Medscape - Mar 23, 2004.