Efficacy and safety of sublingual immunotherapy in children aged 3-13 years with allergic rhinitis.

BACKGROUND Sublingual immunotherapy (SLIT) is recommended for allergic diseases. However, clinical studies containing evidence-based data of this treatment in young children, which is rarely reported in the literature, are needed. This study was designed to assess the efficacy and safety of SLIT in children, including very young children. METHODS Two hundred sixty-four children aged 3-13 years old (133 children, 3-5 years old) with Dermatophagoides farinae-induced allergic rhinitis with or without asthma treated by standard pharmacotherapy had randomly received either SLIT (SLIT group) or no SLIT (control group) for 12 months. Symptoms, medications, visual analog scale (VAS) and presence of adverse events (AEs) were assessed at monthly visits. Skin-prick test and Dermatophagoides farinae-specific IgE and IgG4 were measured before and after treatment. RESULTS Both treatments were effective in the global clinical scores during the first seven visits when compared with baseline (all, p < 0.01), and SLIT showed lower symptoms scores and VAS scores throughout this period (all, p < 0.01). These improvements continued until the later visits only in the SLIT group. Also, the asthma medication consumption was decreased by SLIT treatment only at the end of study (p < 0.01). The specific IgG4 was significantly increased after SLIT treatment when compared with the control group, but no significant change of specific IgE was observed in either groups. In the SLIT group, there was no significant difference between children less than or more than 5 years old in terms of clinical efficacy, onset of action, immunologic parameters, and safety. No severe systemic AEs were reported. CONCLUSION SLIT is effective and well-tolerated in children with allergic rhinitis 3-13 years old.