The Journal of Allergy and Clinical Immunology
Volume 125, Issue 2 , Pages 383-389, February 2010

Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic asthma

  • Marc Massanari, PharmD

      Affiliations

    • Novartis Pharmaceuticals Corp, East Hanover, NJ
    • Corresponding Author InformationReprint requests: Marc Massanari, PharmD, Novartis Pharmaceuticals Corp, One Health Plaza, Building 419-2326, East Hanover, NJ 07936-1080.
    • ,
  • Harold Nelson, MD

      Affiliations

    • National Jewish Health, Denver, Colo
    • ,
  • Thomas Casale, MD

      Affiliations

    • Creighton University, Omaha, Neb
    • ,
  • William Busse, MD

      Affiliations

    • University of Wisconsin, Madison, Wis
    • ,
  • Farid Kianifard, PhD

      Affiliations

    • Novartis Pharmaceuticals Corp, East Hanover, NJ
    • ,
  • Gregory P. Geba, MD, MPH

      Affiliations

    • Novartis Pharmaceuticals Corp, East Hanover, NJ
    • ,
  • Robert K. Zeldin, MD

      Affiliations

    • Novartis Pharmaceuticals Corp, East Hanover, NJ

Received 12 June 2009; received in revised form 13 November 2009; accepted 16 November 2009.

Background

Although specific immunotherapy is a valuable treatment option for patients with allergic asthma, the potential for systemic allergic reactions has limited its use, especially for patients with symptomatic disease.

Objective

To evaluate omalizumab's effect on the tolerability of specific immunotherapy in patients with symptomatic persistent asthma not adequately controlled with inhaled corticosteroids.

Methods

This multicenter, double-blind, parallel-group study randomized patients to treatment with omalizumab or placebo, after which they received specific immunotherapy to at least 1 of 3 perennial aeroallergens (cat, dog, and house dust mite) according to a 4-week, 18-injection cluster regimen, followed by 7 weeks of maintenance therapy. The primary efficacy variable, a systemic allergic reaction after immunotherapy, was analyzed by using the Cochrane-Mantel-Haenszel test.

Results

A total of 248 randomized patients (126 omalizumab, 122 placebo) received at least 1 dose of immunotherapy and were evaluated for efficacy. Patients receiving omalizumab experienced significantly fewer systemic allergic reactions to immunotherapy than those receiving placebo (17/126 [13.5%] vs 32/122 [26.2%]; P = .017; 95% CI, 2.91% to 22.56%) and had fewer respiratory-related (grade 3) systemic allergic reactions (6 vs 24, respectively). Grade 4 reactions were reported in 2 patients in each group. More omalizumab patients were able to reach the target maintenance immunotherapy dose (110 [87.3%] vs 88 [72.1%], respectively; P = .004).

Conclusion

Use of omalizumab in patients whose asthma was symptomatic despite use of inhaled corticosteroids was associated with fewer systemic allergic reactions to specific immunotherapy and enabled more patients to achieve the target immunotherapy maintenance dose.

Key words: Omalizumab, allergic asthma, immunotherapy, systemic allergic reactions, cluster immunotherapy, cat, dog, house dust mites

Abbreviations used: AE, Adverse event, CMH, Cochran-Mantel-Haenszel, HDM, House dust mite, ICS, Inhaled corticosteroid, PEFR, Peak expiratory flow rate, SAR, Systemic allergic reaction, SIT, Specific immunotherapy

 

 Supported by Novartis Pharmaceuticals Corp, East Hanover, NJ, and Genentech, Inc, South San Francisco, Calif.

 Disclosure of potential conflict of interest: M. Massanari, F. Kianifard, and R. K. Zeldin are employed by Novartis. H. Nelson has consultant arrangements with Genentech/Novartis, Abbott Laboratories, MediciNova, AstraZeneca, Amgen, GlaxoSmithKline, Schering-Plough, Dyson, and Sepracor; receives research support from Schering-Plough, Genentech, Ception, and AstraZeneca; and is on the speakers' bureau for GlaxoSmithKline. T. Casale receives research support from Novartis and Genentech. W. Busse has consultant arrangements with Altair, GlaxoSmithKline, Merck, Wyeth, Pfizer, Centocor, Amgen, UCB, Johnson & Johnson, Novartis, AstraZeneca, Eisai, TEVA, CompleWare, KaloBios, Boehringer Ingelheim, and Sandoz and receives research support from the NIH-NIAID, NIH-NHLBI, Novartis, Centocor, GlaxoSmithKline, MedImmune, and Ception. G. P. Geba is a former employee and current stockholder of Novartis.

PII: S0091-6749(09)01741-2

doi:10.1016/j.jaci.2009.11.022

The Journal of Allergy and Clinical Immunology
Volume 125, Issue 2 , Pages 383-389, February 2010

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