Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:121

Article

Dahl, Ronald¹  Kapp, Alexander²  Colombo, Giselda³  De Monchy, Jan G. R.⁴  Rak, Sabina⁵  Emminger, Waltraud⁶  Riis, Bente⁷  Gronager, Pernille M.⁷  Durham, Stephen R.⁸ 

[1] Aarhus Univ Hosp, Dept Resp Dis, Aarhus, Denmark

[2] Hannover Med Sch, Dept Dermatol & Allergol, Hannover, Germany

[3] Osped San Raffaele, Med Interna Allergol, Milan, Italy

[4] Univ Groningen, Univ Med Ctr Groningen, Div Allergol, Groningen, Netherlands

[5] Sahlgrens Univ Hosp, Sect Allerg, Gothenburg, Sweden

[6] Allergie Ambulatorium, Vienna, Austria

[7] Res & Dev, Horsholm, Denmark

[8] Royal Brompton Hosp, Allergy & Clin Immunol Sect, London, England

关键词: allergy;    asthma;    grass pollen;    immunotherapy;    sublingual;    rhinoconjunctivitis;    tablet based;    double-blind;    placebo-controlled;    Phleum pratense;   

DOI  :  10.1016/j.jaci.2007.10.039

来源: Elsevier

【 摘 要 】

Background: This is an interim analysis of a randomized, double-blind, placebo-controlled phase III trial with 3 years of daily treatment with grass tablet immunotherapy (GRAZAX; ALK-Abello A/S, Horsholm, Denmark) or placebo, followed by 2 years of follow-up to assess the persistent efficacy. Objective: We sought to evaluate the efficacy and safety of specific immunotherapy with grass allergen tablets compared with placebo after treatment covering 2 consecutive grass pollen seasons. Methods: The interim analyses included 351 adult participants with moderate-to-severe allergic rhinoconjunctivitis caused by grass pollen. Participants were treated with active (n = 189) or placebo (n = 162) tablets for an average of 22 months. All participants were allowed to use symptomatic rescue medication. Results: The primary efficacy analysis showed highly significant mean reductions of 36% in rhinoconjunctivitis symptom score (P<.0001; median reduction, 44%) and 46% in rhinoconjunctivitis medication score (P<.0001; median reduction, 73%) in the active group relative to the placebo group. Mean rhinoconjunctivitis quality of life was 33% better (P<.0001; median, 40%). Clinical improvements were paralleled by significant changes in allergen-specific immunoglobulins. The treatment was well tolerated, and adverse events led to withdrawal in less than 1% of participants. There were no serious adverse events related to treatment. Conclusion: Grass allergen tablet immunotherapy showed progressive immunologic changes and highly significant efficacy over 2 years of continued treatment.

【 授权许可】

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