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An observational, real‐life safety study of a 5‐grass pollen sublingual tablet in children and adolescents
Author(s) -
Eberle Peter,
Brueck Helmut,
Gall Ralph,
Hadler Meike,
Sieber Jochen,
Karagiannis Efstrathios
Publication year - 2014
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/pai.12298
Subject(s) - medicine , observational study , adverse effect , randomized controlled trial , sublingual immunotherapy , allergy , clinical trial , slit , pediatrics , allergen , immunology , biology , genetics
Background The safety and efficacy of pre‐ and coseasonal sublingual allergen immunotherapy ( SLIT ) with a 5‐grass pollen sublingual tablet have been demonstrated in a randomized clinical trial ( RCT ) in children and adolescents. Observational, ‘real‐life’ studies can usefully complement the results of RCT s. Methods A prospective, open‐label, observational, multicentre post‐marketing study of children and adolescents (aged 5–17, with grass pollen‐induced allergic rhinitis) treated with the 5‐grass pollen sublingual tablet was performed between June 2009 and January 2011 in Germany. Adverse events ( AE s) were recorded during consultations with the investigating physicians; AE s judged to have at least a possible causal link to the tablet were classified as adverse drug reactions ( ADR s). Results Eight hundred and forty‐nine patients were enrolled (by 207 investigating physicians), 829 (mean ± s.d. age: 10.9 ± 3.3 yr) completed the study without major protocol deviations, and 796 were fully documented with respect to AE s. Ninety‐four of the 796 patients (11.8%) experienced at least one ADR on the first day of SLIT and 218 (27.4%) experienced at least one ADR during the study. Four hundred and sixty‐six of the 596 ADR s (78.2%) were mild or moderate. The most common ADR s were throat irritation (19.1% of the reactions), oral paresthesia (8.2%), oral pruritus (6.5%) and oedema mouth (6.2%). Serious ADR s occurred in five patients. No epinephrine use was reported. Seventy‐six of the 829 patients (9.2%) discontinued SLIT due to AE s. Tolerability was judged to be good or very good by patients (84.7%), parents (87.0%) and investigators (89.7%). Conclusions In clinical practice, pre‐ and coseasonal treatment with a 5‐grass pollen sublingual tablet is safe and well tolerated in children and adolescents.