The Journal of Allergy and Clinical Immunology
Volume 118, Issue 2 , Pages 434-440, August 2006

Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis

  • Ronald Dahl, MD

      Affiliations

    • From the Department of Respiratory Diseases, Aarhus University Hospital
    • ,
  • Alexander Kapp, MD

      Affiliations

    • Department of Dermatology and Allergology, Hannover Medical University
    • ,
  • Giselda Colombo, MD

      Affiliations

    • Ospedale San Raffaele del Monte Tabor, Medicina Interna Allergologia, Milan
    • ,
  • Jan G.R. de Monchy, MD

      Affiliations

    • Division of Allergology, University of Groningen
    • ,
  • Sabina Rak, MD

      Affiliations

    • Section of Allergy, Sahlgrenska University Hospital, Gothenburg
    • ,
  • Waltraud Emminger, MD

      Affiliations

    • Allergie-Ambulatorium Rennweg, Vienna
    • ,
  • Montserrat Fernández Rivas, MD

      Affiliations

    • Fundación Hospital Alcorcón, Madrid
    • ,
  • Mette Ribel, MSc

      Affiliations

    • Group Clinical Development, ALK-Abelló A/S, Hørsholm
    • ,
  • Stephen R. Durham, MD

      Affiliations

    • Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College and Royal Brompton Hospital, London
    • Corresponding Author InformationReprint requests: Stephen R. Durham, MD, MRC and Asthma UK Centre in Allergic Mechanisms of Asthma, Head, Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Royal Brompton Hospital, Guy Scadding Building, Royal Brompton Campus, Dovehouse Street, SW3 6LY London, United Kingdom.

Received 20 February 2006; received in revised form 2 May 2006; accepted 4 May 2006.

Aarhus and Hørsholm, Denmark, Hannover, Germany, Milan, Italy, Groningen, The Netherlands, Gothenburg, Sweden, Vienna, Austria, Madrid, Spain, and London, United Kingdom

Background

Allergen immunotherapy (desensitization) by injection is effective for seasonal allergic rhinitis and has been shown to induce long-term disease remission. The sublingual route also has potential, although definitive evidence from large randomized controlled trials has been lacking.

Objective

The aim was to confirm the efficacy of a rapidly dissolving grass allergen tablet (GRAZAX, ALK-Abelló, Hørsholm, Denmark) compared with placebo in patients with seasonal rhinoconjunctivitis.

Methods

A longitudinal, double-blind, placebo-controlled, parallel-group study that included 51 centers from 8 countries. Subjects were randomized (1:1) to receive a grass allergen tablet or placebo once daily. A total of 634 subjects with a history of grass pollen–induced rhinoconjunctivitis for at least 2 years and confirmation of IgE sensitivity (positive skin prick test and serum-specific IgE) were included in the study. Subjects commenced treatment at least 16 weeks before the grass pollen season, and treatment was continued throughout the entire season.

Results

The primary efficacy analysis showed a reduction of 30% in rhinoconjunctivitis symptom score (P < .0001) and a reduction of 38% in rhinoconjunctivitis medication score (P < .0001) compared with placebo. Side effects mainly comprised mild itching and swelling in the mouth that was in general well tolerated and led to treatment withdrawal in less than 4% of participants. There were no serious local side effects and no severe systemic adverse events.

Conclusion

Sublingual immunotherapy with grass allergen tablets was effective in grass pollen–induced rhinoconjunctivitis. The tablet was well tolerated with minor local side effects.

Clinical implications

The grass allergen tablet represents a safe alternative to injection immunotherapy suitable for home use.

Key words: Allergy, asthma, grass pollen, immunotherapy, sublingual, rhinoconjunctivitis, tablet-based, double-blind, placebo-controlled, Phleum pratense

Abbreviations used: SQ-T, Standardized quality tablet, VAS, Visual analog scale

 

 Supported by ALK-Abelló A/S, Denmark.Disclosure of potential conflict of interest: S. R. Durham has consultant arrangements with, has received grant support from, and is on the speakers' bureau for ALK-Abelló. R. Dahl has consultant arrangements with Altana, GlaxoSmithKline, Boehringer Ingelheim, Novartis, and Fertin, and has received grant support from Altana, GlaxoSmithKline, Boehringer Ingelheim, Novartis, AstraZeneca, ALK-Abelló, Roche, and Pfizer. A. Kapp has consultant arrangements with DPC, has received grant support from Novartis, Astellas, UCB, ALK-Abelló, and DPC, and is on the speakers' bureau for Nofartis, Astellas, UCB, and ALK-Abelló. S. Rak has received grant support from the Swedish Asthma and Allergy Association. M. Fernandez-Rivas has received grant support from the European Commission and the Instituto de Salud Carlos III of the Spanish Ministry of Health. M. Ribel is employed by ALK-Abelló A/S. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(06)01135-3

doi:10.1016/j.jaci.2006.05.003

The Journal of Allergy and Clinical Immunology
Volume 118, Issue 2 , Pages 434-440, August 2006

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