Presented at:
61st Annual Meeting of the American Academy of Allergy, Asthma and Immunology
San Antonio, TX, March 18-22, 2004
Omalizumab Plus Rush Immunotherapy (RIT) Is More Effective Than RIT Alone In Preventing Ragweed-Induced Seasonal Allergic Rhinitis (SAR) Symptoms
JN Kline1 , TB Casale2, WW Busse3, ZK Ballas1, M Mokhtarani4, C Bromstead4, V Seyfert-
Margolis5, A. Asare5, K Bateman6, MH Moss3, RG Townley2
1. University of Iowa, Iowa City, IA; 2. Creighton University, Omaha, NE; 3. University of Wisconsin, Madison, WI; 4. Immune Tolerance Network, San Francisco, CA; 5. Immune Tolerance Network, Bethesda, MD; 6. PPD Development, Wilmington, NC.
Rationale: To examine whether omalizumab given 9 weeks prior to RIT followed by 12 weeks of dual omalizumab plus IT is more effective than IT alone in preventing ragweed-induced SAR symptoms.
Methods: Adult patients with positive history and skin test for ragweed sensitivity were enrolled in a double-blinded, parallel group, 3-center, placebo-controlled trial. Patients received either 9 weeks of omalizumab (0.016 mg/kg/IgE [IU/ml] /mo) or placebo, followed by 1 day RIT (1.2 - 4.0 mcg ambA1) or placebo RIT followed by 12 weeks of dual therapy (omalizumab plus IT or placebo plus IT). Primary endpoint was average daily allergy severity score, average of scores for nasal congestion/stuffiness; sneezing; itchy nose, throat and palate; itchy, watery eyes; and rhinorrhea, 0 – 3 scale.
Results: One hundred fifty-nine patients were randomized, and 123 completed all treatments (per protocol, PP patients). Ragweed-specific IgG levels increased > 10-fold in the RIT groups. In the ITT population, average daily allergy severity score was significantly better in the omalizumab plus IT group (0.68) versus IT alone (0.84), p=0.033. In the PP population, allergy severity score AUC was significantly lower in the omalizumab plus IT group, 25.78, versus IT alone, 37.29, p=0.02. In the PP population, mean average daily severity scores were least in the omalizumab plus IT group, 0.58, versus 0.84 IT alone (p=0.01); 0.86, omalizumab alone (p=0.034) and 0.94, placebo (p=0.034).
Conclusion: Omalizumab plus IT is a more effective treatment for SAR than IT alone.