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Omalizumab Plus RIT Gives Extra Boost in Preventing Seasonal Allergic Rhinitis: Presented at AAAAI

By Paula Moyer

SAN ANTONIO, TX -- March 24, 2005 -- Patients with seasonal allergic rhinitis get more relief from their symptoms if they receive omalizumab (Xolair) along with rush immunotherapy (RIT) than if they undergo RIT as monotherapy, according to a investigators who presented findings here on March 22^nd at the 61^st annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Rush immunotherapy is an expedited form of immunotherapy in which patients are on a rapid titration schedule. The purpose of RIT is to shorten the length of time it takes for patients to receive their maximal dose and therefore their maximal benefit.

"In this study the allergy severity score was much lower in patients on combination therapy than in patients on immunotherapy alone," according to presenting investigator Thomas B. Casale, MD, chief, division of allergy and immunology, and director of clinical research and professor of medicine and assistant chair, Creighton University, Omaha, Nebraska, United States. "Therefore, the findings suggest that omalizumab plus immunotherapy is a more effective treatment for seasonal allergic rhinitis." Dr. Casale is.

The investigators conducted their study to determine whether omalizumab -- which binds to immunoglobulin (Ig) E -- in combination with immunotherapy would be more effective than immunotherapy alone for preventing ragweed-induced symptoms of seasonal allergic rhinitis.

The researchers recruited 159 adults with a positive history and skin test for ragweed sensitivity to participate in a double-blinded, parallel group, placebo-controlled trial. Patients received omalizumab for 9 weeks before commencing RIT, and then received omalizumab and immunotherapy for 12 weeks.

Patients were randomized to receive either 9 weeks of omalizumab or placebo, followed by 1 day of RIT or placebo, and then 12 weeks of dual therapy, consisting of omalizumab and immunotherapy or placebo plus immunotherapy. omalizumab was to be given at a dose of 0.016 mg/kg/IgE (IU/mL) per month. The dosage for RIT was to be 1.2 mcg to 4.0 mcg of ambA1, the dominant ragweed allergen.

The primary endpoint of the study was the patients' average daily allergy severity score, which consisted of the average of scores for nasal congestion or stuffiness, sneezing, itchy nose, throat and palate, itchy and watery eyes, and rhinorrhea. The symptoms were graded on a scale of 0 to 3 that ascended in severity.

Patients were monitored for changes in peripheral blood cell populations, gene expression, and cytokine production.

Of the original group of recruits, 123 patients completed all treatments and were categorised as per-protocol patients. The ragweed-specific IgG levels increased more than 10-fold in both the RIT groups, whether they were on combination therapy or immunotherapy alone.

For all of the 159 patients, average daily allergy severity score was 0.69 in the combination group and 0.86 in the group receiving immunotherapy alone, a difference that was statistically significant (P =.044).

In the per-protocol population, the allergy severity score area-under-the-curve (AUC) was 31.20 in the combination therapy group compared to 41.10 for the monotherapy group (P =.027). Among these patients, the average daily score was 0.68 in the combination therapy group and 0.92 in the immunotherapy alone group (P =.015). The daily severity score average for omalizumab alone was 0.88 and 0.87 for placebo (P =.029 and P =.041, respectively).

The study was funded in part by Genentech and Novartis, which are in partnership to manufacture and market Xolair.


[Presentation Title: Omalizumab Plus Rush Immunotherapy (RIT) Is More Effective Than RIT Alone in Preventing Ragweed-Induced Seasonal Allergic Rhinitis (SAR) Symptoms. Abstract #827]

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