Abstract
Background/Objectives: Allergen immunotherapy is the sole therapeutic option capable of modifying the natural course of allergic rhinitis and preventing the development of asthma. Results from paediatric patients are scarce. To evaluate the effectiveness and safety of a glutaraldehyde-modified extract of mites (Beltavac(®)) administered for one year under clinical routine conditions in children between 3 and 11 years old. Methods: This was a multicentre, prospective, 13-month cohort study. Among 97 children diagnosed with immunoglobulin E-mediated house dust mite allergic rhinoconjunctivitis, 87 initiated the subcutaneous immunotherapy. The main outcomes included the Combined Symptoms and Medication Score (CSMS), assessed for 1 month at baseline and after 1, 6, and 12 months, and the number of adverse reactions according to the WAO adverse reaction grading system. The levels of serum-specific immunoglobulins were also assessed. Results: CSMS improved scores throughout therapy (adjusted mean change and 95% confidence interval: 0.55, 0.26-0.84 points; p < 0.001). Improvements occurred in both children with (n = 68) and without asthma (n = 19), as well as in children aged ≥6 years (n = 76) and <6 years (n = 11), although statistical significance was not reached in the smallest subgroups. Eight children (9.2%) developed a total of 15 adverse reactions. Most occurred after the initial dose (five out of eight children), and were local (six out of eight) and minor (five out of eight). Over 90% of patients completed the full regimen. Conclusions: This study supports the effectiveness and safety of allergen immunotherapy administered according to a rush schedule for one year for paediatric allergic rhinitis.