High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:130

Article

Wahn, Ulrich¹  Klimek, Ludger²  Ploszczuk, Anna³  Adelt, Thomas^4,5  Sandner, Bernhard^5,6  Trebas-Pietras, Ewa⁷  Eberle, Peter⁸  Bufe, Albrecht^5,9 

[1] Charite, Dept Pediat Pneumol & Immunol, D-13353 Berlin, Germany

[2] Ctr Rhinol & Allergol, Wiesbaden, Germany

[3] Univ Childrens Hosp, Dept Allergol, Bialystok, Poland

[4] Pediat Ctr, Bramsche, England

[5] NETSTAP eV, Network Pediatricians Clin Studies, Bochum, Germany

[6] Pediat Ctr, Aschaffenburg, England

[7] Hlth Care Ctr Allergol, Lublin, Poland

[8] Pediat Ctr, Kassel, Germany

[9] Ruhr Univ Bochum, Bochum, Germany

关键词: Sublingual immunotherapy;    single-dose;    high-dose;    pre-/co-seasonal treatment;    allergic rhinitis/rhinoconjunctivitis;    children;    double-blind placebo-controlled trial;    efficacy;    safety;    grass polle;   

DOI  :  10.1016/j.jaci.2012.06.047

来源: Elsevier

【 摘 要 】

Background: Sublingual allergen-specific immunotherapy is a viable alternative to subcutaneous immunotherapy particularly attractive for use in children. Objective: This study investigated efficacy and safety of high-dose sublingual immunotherapy (SLIT) in children allergic to grass pollen in a randomized, double-blind, placebo-controlled trial. Methods: After a baseline seasonal observation, 207 children aged 4 to 12 years with grass pollen-allergic rhinitis/rhinoconjunctivitis with/without bronchial asthma (Global Initiative for Asthma I/II) received either high-dose grass pollen SLIT or placebo daily for 1 pre-/co-seasonal period. The primary end point was the change of the area under the curve of the symptom-medication score (SMS) from the baseline season to the first season after start of treatment. Secondary outcomes were well days, responders, immunologic changes, and safety. Results: Mean changes in the area under the curve of the SMS from the baseline to the first grass pollen season after the start of treatment were -212.5 for the active group and -97.8 for the placebo group (P = .0040). Rhinoconjunctivitis SMS (P = .0020) and separated symptom and medication scores were also statistically different between the 2 groups (P = .0121 and P = .0226, respectively). The number of well days and the percentage of responders were greater in the active group. Changes in allergen-specific IgE and IgG levels indicated a significant immunologic effect. The treatment was well tolerated, and no serious treatment-related events were reported. Conclusions: This study confirmed that this SLIT preparation significantly reduced symptoms and medication use in children with grass pollen-allergic rhinoconjunctivitis. The preparation showed significant effects on allergen-specific antibodies, was well tolerated, and appeared to be a valid therapeutic option in children allergic to grass pollen. This trial was registered at www.clinicaltrials.gov as NCT00841256. (J Allergy Clin Immunol 2012; 130:886-93.)

【 授权许可】

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