Real-world safety and effectiveness evidence of a microcrystalline tyrosine-associated mite allergoid in children and adolescents with allergic rhinitis

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 andwithout 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.

The Impact of Processing and Extraction Methods on the Allergenicity of Targeted Protein Quantification as Well as Bioactive Peptides Derived from Egg

“…The disulfide bonds within its three structurally distinct domains (I, II, and III) aid in its resistance to heat denaturation and proteolytic digestion [ 229 , 230 ]. OVM is a serine protease inhibitor that protects against trypsin and elastase, among other proteolytic enzymes [ 231 , 232 ]. Regarding allergenicity, domain III is the most important since it contains both IgE- and IgG-binding epitopes, making it a primary determinant of egg allergy [ 229 , 230 ].…”

MicroCrystalline Tyrosine-adsorbed immunotherapy

“…Since their inception in the 1970s, more than 100 published studies have been conducted with Allergoid-MCT-based AIT in over 17 000 patients [ 22 , 29 , 33 ▪ , 38 , 41 – 57 , 58 ▪▪ , 59 ▪ , 60 ▪ , 61 – 63 , 64 ▪▪ , 65 , 66 ]. These studies include a wide and heterogeneous variety of allergen extracts (including grass, trees, weeds and mites), product platforms (including Allergoid-MCT and PQ) and study designs (including DBPC trials, biomarker studies, noncontrolled studies, noninterventional studies and investigator-initiated research).…”

“…These studies include a wide and heterogeneous variety of allergen extracts (including grass, trees, weeds and mites), product platforms (including Allergoid-MCT and PQ) and study designs (including DBPC trials, biomarker studies, noncontrolled studies, noninterventional studies and investigator-initiated research). Several studies have also enrolled children and adolescents [ 33 ▪ , 51 , 55 , 58 ▪▪ , 65 ].…”

“…It can be anticipated that this fully biodegradable adjuvants will also in future studies not reveal side effects [ 72 ]. All available data demonstrate a convincing overall safety and tolerability profile for MCT-adsorbed immunotherapy products: In 43 studies using pollen Allergoid-MCT [ 33 ▪ ], 9 studies using mite Allergoid-MCT [ 58 ▪▪ , 59 ▪ , 60 ▪ , 61 , 62 , 63 , 64 ▪▪ , 65 , 66 ] and 20 studies using PQ [ 22 , 29 , 38 , 41 – 57 ], no treatment-related serious adverse events have been reported.…”