Sublingual specific immunotherapy for adults and children: a post-marketing surveillance study.

BACKGROUND Sublingual immunotherapy (SLIT) is a relatively new form of treatment for type I allergies and a good safety profile is rapidly being established. Evidence on the efficacy of SLIT is increasing, and the present study provides further supportive data. We describe the results of treatment with a SLIT vaccine formulated with a range of allergen extracts obtained by allergologists in daily clinical practice. METHODS Adult and child patients (n = 159, 81 males, 78 females) with confirmed type I allergic sensitivities were treated with a standardized SLIT vaccine (ORALVAC) using the sublingual-swallow method. Evaluation of the efficacy of SLIT was based on the consumption of anti-allergic medication and a global assessment. Tolerability assessment was based on the incidence of local or systemic reactions. RESULTS Medication use was significantly reduced compared with that in previous years (p = 0.023). In a large subgroup of patients treated for pollen sensitivity the significance was stronger (p = 0.016). Global assessment revealed that only 3.5 % of patients showed no change in symptoms after therapy. High tolerability was achieved and no serious or severe adverse effects were observed. CONCLUSION Over a one-year period, adult and child patients with a variety of type I allergies were treated with a SLIT vaccine that has shown significant efficacy and was well-tolerated with no serious or severe adverse events.