Aim: Multicenter study to investigate the safety of mite extract product Novo-Helisen Depot, Strengths 1 to 3 (NHD3), as subcutaneous immunotherapy (SCIT), in Chinese children and adolescents with allergic rhinitis (AR) and allergic asthma (AA). Patients & methods: We evaluated SCIT-related adverse events (AEs) during NHD3 14-week initial therapy in children (5-11 years) and adolescents (12-17 years) with perennial symptomatic AR and AA. Results: Among 3600 injections in 250 patients, 361/3600 (10.0%) injections caused SCIT-related AEs in 96/250 (38.4%) patients, 321/3600 injections (8.9%) caused local reactions in 89/250 (35.6%) and 40/3600 injections (1.1%) caused systemic reactions in 23/250 (9.2%). Conclusion: Initial SCIT treatment using NHD3 was safe and well tolerated in Chinese children and adolescents with AR and AA.
Keywords: adolescents; allergic rhinitis; asthma; children; house dust mite; multicenter; safety; semi-depot allergen extract; subcutaneous immunotherapy; tolerability.