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Multicenter Study
. 2021 Jul 1;49(4):98-108.
doi: 10.15586/aei.v49i4.195. eCollection 2021.

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

Sala-Cunill Anna  1 , Almeida-Sánchez Zulay M  2 , García-Núñez Ignacio  3   4 , Laín Sofia  5 , Martínez-Tadeo Juan A  6 , Martos Maria D  7 , Núñez Ramón  8 , Ramírez Mercedes  9 , Boronat Anna  10 , Torán-Barona Carla  10 , Justicia José L  10
Affiliations
Multicenter Study

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

Sala-Cunill Anna et al. Allergol Immunopathol (Madr). .

Abstract

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.

Keywords: allergic rhinitis; children and adolescents; microcrystalline tyrosine; mites; real-world evidence; subcutaneous allergen immunotherapy.

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Conflict of interest statement

AS-C has received consultancy fees from Allergy Therapeutics Ibérica, Merck, Circassia, ALK-Abelló, and Leti Pharma. IG-N has received personal fees from ALK-Abelló, Stallergenes, and Mundipharma. AB, CT-B, and JLJ are employees of Allergy Therapeutics. ZMA-S, SL, JAM-T, MDM, and RN have nothing to disclose.

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