High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study - 29/09/12
, Ludger Klimek, MD b, Anna Ploszczuk, MD c, Thomas Adelt, MD d, e, Bernhard Sandner, MD e, f, Ewa Trebas-Pietras, MD g, Peter Eberle, MD h, Albrecht Bufe, MD e, iSLIT Study Group
Corresponding author: Ulrich Wahn, MD, Department for Pediatric Pneumology and Immunology, Charité Medical University, Augustenburger Platz 1, 13353 Berlin, Germany.Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Sublingual immunotherapy, single-dose, high-dose, pre-/co-seasonal treatment, allergic rhinitis/rhinoconjunctivitis, children, double-blind placebo-controlled trial, efficacy, safety, grass pollen
Abbreviations used : AE, AUC, DBPC, EMA, FAS, MS, RC-SMS, SAE, SIT, SLIT, SMD, SMS, SS
Plan
| Disclosure of potential conflict of interest: U. Wahn has received research support from Allergopharma. L. Klimek has received research support from Allergopharma, ALK-Abelló, HAL, Novartis, and GlaxoSmithKline and has consultant arrangements with Boehringer Ingelheim. A. Bufe has consultant arrangements with ALK-Abelló, Bitop AG, and NETSTAP Forschungs GmbH and has received lecture fees from ALK-Abelló and Allergopharma. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 130 - N° 4
P. 886 - octobre 2012 Retour au numéro
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