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Tolerability of Retreatment with Omalizumab, a Recombinant Humanized Monoclonal Anti-IgE Antibody, during a Second Ragweed Pollen Season in Patients with Seasonal Allergic Rhinitis

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Abstract:

Two randomized, placebo-controlled, double-blind studies have shown clinical benefit with omalizumab (Xolair), a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody, at a dose of 300 mg every 3 or 4 weeks in patients with seasonal allergic rhinitis. The present open-label, 12-week study was designed to assess the safety and tolerability of retreatment with omalizumab in 287 patients previously treated with this agent in one of the latter studies. Omalizumab, 300 mg, was administered subcutaneously every 4 weeks (three injections) to patients with IgE levels ≤150 IU/mL (n = 182) and every 3 weeks (four injections) to patients with IgE levels > 150 IU/mL (n = 105) at screening before retreatment. Reported adverse events were monitored and blood samples were analyzed for laboratory safety (hematology and serum chemistry) and IgE levels. Urinalysis also was completed as part of the laboratory safety evaluation. The overall incidence and pattern of adverse events were similar to those reported in the primary study. There were no severe or serious adverse events related to omalizumab treatment and no anti-omalizumab antibodies were detected in any patient. Two patients withdrew from treatment because of adverse events (skin rash and nausea; facial erythema and edema) related to study treatment. Free IgE levels decreased to the levels associated with symptom reduction in the core study. In summary, retreatment during a second pollen season with omalizumab, 300 mg every 3 or 4 weeks, was well tolerated and was not associated with any significant immunologic reactions.

Document Type: Original Article

Publication date: September 1, 2003

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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