Real-World Safety and Effectiveness Evidence of a Microcrystalline Tyrosine-Associated Mite Allergoid in Children and Adolescents with Allergic Rhinitis

Evidence regarding allergen immunotherapy (AIT) in pediatric population is scarce. We have assessed safety and effectiveness of subcutaneous AIT with a microcrystalline tyrosine (MCT)-associated mite allergoid, Acarovac Plus®, in children and adolescents with allergic rhinitis (AR), with and without asthma, in the real-world setting. This was a retrospective, multicenter study including children and adolescents aged 5 years to 17 years with AR, with and without asthma, and sensitized to mites, receiving AIT with Acarovac Plus® during ≥6 months. Primary and secondary objectives were safety and effectiveness, respectively. Effectiveness variables were assessed during 12 months before and after AIT and included unscheduled visits to the healthcare center and emergency room admissions, rhinitis and asthma symptoms according to ARIA and GEMA classifications, respectively, medication use, and patients’ and physicians’ disease perception graded on a visual analog scale (VAS). All 79 patients included had a mean (SD) age of 12.7 (3.3) years. Two patients experienced systemic adverse reactions (none severe). Unscheduled visits to the healthcare center and emergency room admissions decreased (mean (SD) 3.02 [2.48] and 0.63 [1.35] vs. 1.08 [1.38] and 0.09 [0.38], before and after treatment, p < 0.001 and p = 0.001, respectively). After AIT, rhinitis and asthma classification changed (p < 0.0001 for all classifications), showing improvements in symptoms and a significant decrease in rhinitis and use of medication for asthma and VAS scores grading patients’ and physicians’ disease perception (p < 0.001). In conclusion, these results show that AIT with an MCT-associated mite allergoid appears safe and effective in children and adolescents with AR treated in the real-world setting (AU)

Safety and effectiveness of a microcrystalline tyrosine-associated mite extract immunotherapy for allergic rhinitis.

Aim: To assess the safety and effectiveness of an allergen immunotherapy (AIT) with a microcrystalline tyrosine-associated mite allergoid in real-world patients with allergic rhinitis (AR). Materials & methods: Retrospective, multicenter study assessing the safety of AIT in patients aged 5 to 65 years with AR, with or without asthma, sensitized to mites. Secondary objective was effectiveness, measured as unscheduled visits to healthcare centers and emergency rooms, rhinitis and asthma evolution, medication use and patients' and physicians' disease perception 12 months before and after treatment. Results: The 306 patients evaluated, with a mean (standard deviation) age of 29.68 (14.66) years, received different treatment compositions and regimens, and 25 (8.2%) experienced nonserious adverse reactions. Unscheduled visits to the specialist and emergency room admissions significantly decreased after immunotherapy (mean [standard deviation] 2.11 [1.95] and 0.3 [0.93] vs 0.66 [1.09] and 0.02 [0.2], before and after treatment, respectively). Rhinitis and asthma classification ('AR and its impact on asthma' and 'Guía Española para el Manejo del Asma', respectively) significantly changed (p < 0.0001 for all classifications), showing symptom reduction after AIT. Median (interquartile range)-combined rhinitis and combined asthma medication scores significantly decreased (4.0 [1.33, 7.0] vs 0.25 [0, 10.0]; p < 0.0001 and 6.94 [1.5, 6.0] vs 0.67 [0, 4.67]; p < 0.0001) within 12 months before and after starting AIT, respectively. Conclusion: AIT with microcrystalline tyrosine-associated mite allergoid appears to be safe and effective in treating rhinitis caused by mites.