Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis

Thomas B. Casale, William W. Busse, Joel N. Kline, Zuhair K. Ballas, Mark H. Moss, Robert G. Townley, Masoud Mokhtarani, Vicki Seyfert-Margolis, Adam Asare, Kirk Bateman, Yamo Deniz

Research output: Contribution to journalArticle

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Abstract

Background: Rush immunotherapy (RIT) presents an attractive alternative to standard immunotherapy. However, RIT carries a much greater risk of acute allergic reactions, including anaphylaxis. Objectives: We hypothesized that omalizumab, a humanized monoclonal anti-IgE antibody, would be effective in enhancing both safety and efficacy of RIT. Methods: Adult patients with ragweed allergic rhinitis were enrolled in a 3-center, 4-arm, double-blind, parallel-group, placebo-controlled trial. Patients received either 9 weeks of omalizumab (0.016 mg/kg/IgE [IU/mL]/mo) or placebo, followed by 1-day rush (maximal dose 1.2-4.0 μg Amb a 1) or placebo immunotherapy, then 12 weeks of omalizumab or placebo plus immunotherapy. Results: Of the 159 patients enrolled, 123 completed all treatments. Ragweed-specific IgG levels increased >11-fold in immunotherapy patients, and free IgE levels declined >10-fold in omalizumab patients. Patients receiving omalizumab plus immunotherapy had fewer adverse events than those receiving immunotherapy alone. Post hoc analysis of groups receiving immunotherapy demonstrated that addition of omalizumab resulted in a 5-fold decrease in risk of anaphylaxis caused by RIT (odds ratio, 0.17; P = .026). On an intent-to-treat basis, patients receiving both omalizumab and immunotherapy showed a significant improvement in severity scores during the ragweed season compared with those receiving immunotherapy alone (0.69 vs 0.86; P = .044). Conclusion: Omalizumab pretreatment enhances the safety of RIT for ragweed allergic rhinitis. Furthermore, combined therapy with omalizumab and allergen immunotherapy may be an effective strategy to permit more rapid and higher doses of allergen immunotherapy to be given more safely and with greater efficacy to patients with allergic diseases.

Original languageEnglish
Pages (from-to)134-140
Number of pages7
JournalJournal of Allergy and Clinical Immunology
Volume117
Issue number1
DOIs
StatePublished - Jan 2006

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Ambrosia
Seasonal Allergic Rhinitis
Immunotherapy
Placebos
Immunologic Desensitization
Anaphylaxis
Omalizumab
Immunoglobulin E
Safety

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

Cite this

Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. / Casale, Thomas B.; Busse, William W.; Kline, Joel N.; Ballas, Zuhair K.; Moss, Mark H.; Townley, Robert G.; Mokhtarani, Masoud; Seyfert-Margolis, Vicki; Asare, Adam; Bateman, Kirk; Deniz, Yamo.

In: Journal of Allergy and Clinical Immunology, Vol. 117, No. 1, 01.2006, p. 134-140.

Research output: Contribution to journalArticle

Casale, TB, Busse, WW, Kline, JN, Ballas, ZK, Moss, MH, Townley, RG, Mokhtarani, M, Seyfert-Margolis, V, Asare, A, Bateman, K & Deniz, Y 2006, 'Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis', Journal of Allergy and Clinical Immunology, vol. 117, no. 1, pp. 134-140. https://doi.org/10.1016/j.jaci.2005.09.036
Casale, Thomas B. ; Busse, William W. ; Kline, Joel N. ; Ballas, Zuhair K. ; Moss, Mark H. ; Townley, Robert G. ; Mokhtarani, Masoud ; Seyfert-Margolis, Vicki ; Asare, Adam ; Bateman, Kirk ; Deniz, Yamo. / Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. In: Journal of Allergy and Clinical Immunology. 2006 ; Vol. 117, No. 1. pp. 134-140.
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abstract = "Background: Rush immunotherapy (RIT) presents an attractive alternative to standard immunotherapy. However, RIT carries a much greater risk of acute allergic reactions, including anaphylaxis. Objectives: We hypothesized that omalizumab, a humanized monoclonal anti-IgE antibody, would be effective in enhancing both safety and efficacy of RIT. Methods: Adult patients with ragweed allergic rhinitis were enrolled in a 3-center, 4-arm, double-blind, parallel-group, placebo-controlled trial. Patients received either 9 weeks of omalizumab (0.016 mg/kg/IgE [IU/mL]/mo) or placebo, followed by 1-day rush (maximal dose 1.2-4.0 μg Amb a 1) or placebo immunotherapy, then 12 weeks of omalizumab or placebo plus immunotherapy. Results: Of the 159 patients enrolled, 123 completed all treatments. Ragweed-specific IgG levels increased >11-fold in immunotherapy patients, and free IgE levels declined >10-fold in omalizumab patients. Patients receiving omalizumab plus immunotherapy had fewer adverse events than those receiving immunotherapy alone. Post hoc analysis of groups receiving immunotherapy demonstrated that addition of omalizumab resulted in a 5-fold decrease in risk of anaphylaxis caused by RIT (odds ratio, 0.17; P = .026). On an intent-to-treat basis, patients receiving both omalizumab and immunotherapy showed a significant improvement in severity scores during the ragweed season compared with those receiving immunotherapy alone (0.69 vs 0.86; P = .044). Conclusion: Omalizumab pretreatment enhances the safety of RIT for ragweed allergic rhinitis. Furthermore, combined therapy with omalizumab and allergen immunotherapy may be an effective strategy to permit more rapid and higher doses of allergen immunotherapy to be given more safely and with greater efficacy to patients with allergic diseases.",
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AU - Moss, Mark H.

AU - Townley, Robert G.

AU - Mokhtarani, Masoud

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AU - Bateman, Kirk

AU - Deniz, Yamo

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