Post-marketing surveillance study on the safety of sublingual immunotherapy in pediatric patients

Background: Immunotherapy (IT) is the only causal treatment for allergic su bjects recognized to be effective and to offer longlasting efficacy. The no ninjective routes, aimed at improving the safety of the treatment, have bee n validated as effective in adults, but documentation of their safety in ch ildren is still poor. The aim of the present survey study was to assess the safety of sublingual immunotherapy in pediatric patients, by evaluating a large population. Methods: A total of 268 children (aged 2-15 years), receiving sublingual IT for respiratory allergy, were followed-up over a period ranging from 3 mon ths to 7 years (mean 34 months). The side-effects possibly due to the treat ment were recorded on a proper diary card; self-assessment of the clinical outcome was also evaluated. Results: About 96 000 doses of extract were globally administered. Local si de-effects were of no clinical relevance. Eight side effects were reported (3% of patients; 0.083 per 1000 doses). Seven systemic side-effects (abdomi nal pain, conjunctival itching, and rhinitis) were mild and. required no tr eatment. One case of urticaria was well controlled with oral antihistamines . No life-threatening event occurred. The clinical outcome was judged excel lent or good by 80% of the patients. Conclusions: The sublingual IT herein investigated appeared to be well tole rated and safe in pediatric patients. The risk/benefit ratio was therefore favorable.