Food allergy in adolescents: validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire into Spanish.

BACKGROUND: Different questionnaires have been developed globally to assess and compare the impact of food allergy on the quality of life. The aim of this study was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy-Quality of Life Questionnaire-Teenage Form (FAQLQ-TF) for adolescents aged 13-17 years. METHODS: Sixty adolescents diagnosed with immunoglobulin E-mediated allergy to food completed the questionnaires. Cronbach's alpha was used to assess internal consistency; correlation between FAQLQ-TF and FAIM was used to test construct validity. The discriminant validity was evaluated by comparison with the number of offending foods, the perceived impact on social life, the diagnosis of anaphylaxis, and the previous prescription of adrenaline auto--injectors (AAI). RESULTS: No question fulfilled criteria to be removed from the questionnaire. For FAIM, Cronbach's alpha = 0.763, and for the four domains of FAQLQ-TF, Cronbach's alpha = 0.797-0.847. A significant correlation existed between FAQLQ-TF and FAIM, and of both of them with anaphylaxis and the prescription of AAI (P ˂ 0.05 for all comparisons). CONCLUSIONS: This Spanish translation of FAIM and FAQLQ-TF for adolescents had good internal consistency and construct validity as well as ability to discriminate patients according to the number of foods to avoid, impact on social life, diagnosis of anaphylaxis, and AAI prescription.

Food allergy in adolescents: validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire into Spanish

Background: Different questionnaires have been developed globally to assess and compare the impact of food allergy on the quality of life. The aim of this study was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy–Quality of Life Questionnaire–Teenage Form (FAQLQ-TF) for adolescents aged 13–17 years. Methods: Sixty adolescents diagnosed with immunoglobulin E-mediated allergy to food completed the questionnaires. Cronbach’s alpha was used to assess internal consistency; correlation between FAQLQ-TF and FAIM was used to test construct validity. The discriminant validity was evaluated by comparison with the number of offending foods, the perceived impact on social life, the diagnosis of anaphylaxis, and the previous prescription of adrenaline auto--injectors (AAI). Results: No question fulfilled criteria to be removed from the questionnaire. For FAIM, Cronbach’s alpha = 0.763, and for the four domains of FAQLQ-TF, Cronbach’s alpha = 0.797–0.847. A significant correlation existed between FAQLQ-TF and FAIM, and of both of them with anaphylaxis and the prescription of AAI (P ˂ 0.05 for all comparisons). Conclusions: This Spanish translation of FAIM and FAQLQ-TF for adolescents had good internal consistency and construct validity as well as ability to discriminate patients according to the number of foods to avoid, impact on social life, diagnosis of anaphylaxis, and AAI prescription (AU)

First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy.

BACKGROUND: Polymerized allergens conjugated to non-oxidized mannan (PM-allergoids) are novel vaccines targeting dendritic cells (DCs). Previous experimental data indicate that PM-allergoids are readily taken up by DCs and induce Treg cells. This first-in-human study was aimed to evaluate safety and to find the optimal dose of house dust mite PM-allergoid (PM-HDM) administered subcutaneously (SC) or sublingually (SL). METHODS: In a randomized, double-blind, double-dummy, placebo-controlled trial, 196 subjects received placebo or PM-HDM at 500, 1000, 3000, or 5000 mannan-conjugated therapeutic units (mTU)/mL in 9-arm groups for 4 months. All subjects received 5 SC doses (0.5 ml each) every 30 days plus 0.2 ml SL daily. The primary efficacy outcome was the improvement of titrated nasal provocation tests (NPT) with D. pteronyssinus at baseline and at the end of the study. All adverse events and reactions were recorded and assessed. Secondary outcomes were the combination of symptom and medication scores (CSMS) and serological markers. RESULTS: No moderate or severe adverse reactions were reported. Subjects improving the NPT after treatment ranged from 45% to 62% in active SC, 44% to 61% in active SL and 16% in placebo groups. Statistical differences between placebo and active groups were all significant above 500 mTU, being the highest with 3000 mTU SL (p = 0.004) and 5000 mTU SC (p = 0.011). CSMS improvement over placebo reached 70% (p < 0.001) in active 3000 mTU SC and 40% (p = 0.015) in 5000 mTU SL groups. CONCLUSIONS: PM-HDM immunotherapy was safe and successful in achieving primary and secondary clinical outcomes in SC and SL at either 3000 or 5000 mTU/ml.

Validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire for children 8-12 years translated into Spanish.

BACKGROUND: Different questionnaires have been developed to measure quality of life (QoL) in patients with food allergy. Our aim was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy Quality of Life Questionnaire-Child Form (FAQLQ-CF) for children aged 8-12 years. METHODS: Sixty children with a diagnosis of IgE-mediated allergy to food completed the questionnaires. The internal consistency was evaluated with Cronbach's alpha. The correlation of FAQLQ-CF with FAIM was assessed to test construct validity. We compared both values with the diagnosis of anaphylaxis to evaluate discriminant validity. RESULTS: Cronbach's alpha was in the range of 0.654-0.863 for the four domains of FAQLQ-CF and 0.779 for FAIM. There were no criteria to remove questions from the questionnaires. Significant correlations could be found between FAQLQ-CF and the number of offending foods and the impact on social life (all r > 0.33, P < 0.01), and between FAIM and anaphylaxis. CONCLUSIONS: The Spanish translation of FAQLQ-CF showed acceptable internal consistency, good construct validity, and capacity to discriminate patients depending on the number of foods to avoid and the impact on social life. FAIM showed good discriminant capacity for anaphylaxis.

Heterogeneity of pollen food allergy syndrome in seven Southern European countries: The @IT.2020 multicenter study.

BACKGROUND: Pollen food allergy syndrome (PFAS) is a frequently underdiagnosed disease due to diverse triggers, clinical presentations, and test results. This is especially relevant in geographic areas with a broad spectrum of pollen sensitization, such as Southern Europe. OBJECTIVES: To elucidate similarities and differences of PFAS in nine Southern European centers and identify associated characteristics and unique markers of PFAS. METHODS: As part of the @IT.2020 Multicenter Study, 815 patients with seasonal allergic rhinitis (SAR), aged 10-60 years, were recruited in seven countries. They completed questionnaires regarding SAR, comorbidities, family history, and PFAS, and underwent skin prick testing (SPT) and serum IgE testing. RESULTS: Of the 815 patients, 167 (20.5%) reported PFAS reactions. Most commonly, eliciting foods were kiwi (58, 34.7%), peach (43, 25.7%), and melon (26, 15.6%). Reported reactions were mostly local (216/319, 67.7%), occurring within 5 min of contact with elicitors (209/319, 65.5%). Associated characteristics included positive IgE to at least one panallergen (profilin, PR-10, or nsLTP) (p = 0.007), maternal PFAS (OR: 3.716, p = 0.026), and asthma (OR: 1.752, p = 0.073). Between centers, heterogeneity in prevalence (Marseille: 7.5% vs. Rome: 41.4%, p < 0.001) and of clinical characteristics was apparent. Cypress played a limited role, with only 1/22 SPT mono-sensitized patients reporting a food reaction (p < 0.073). CONCLUSIONS: PFAS is a frequent comorbidity in Southern European SAR patients. Significant heterogeneity of clinical characteristics in PFAS patients among the centers was observed and may be related to the different pollen sensitization patterns in each geographic area. IgE to panallergen(s), maternal PFAS, and asthma could be PFAS-associated characteristics.

"Whole" vs. "fragmented" approach to EAACI pollen season definitions: A multicenter study in six Southern European cities.

BACKGROUND: The adequate definition of pollen seasons is essential to facilitate a correct diagnosis, treatment choice, and outcome assessment in patients with seasonal allergic rhinitis. A position paper by the European Academy of Allergy and Clinical Immunology (EAACI) proposed season definitions for Northern and Middle Europe. OBJECTIVE: To test the pollen season definitions proposed by EAACI in six Mediterranean cities for seven pollen taxa. METHODS: As part of the @IT.2020 multi-center study, pollen counts for Poaceae, Oleaceae, Fagales, Cupressaceae, Urticaceae (Parietaria spp.), and Compositae (Ambrosia spp., Artemisia spp.) were collected from January 1 to December 31, 2018. Based on these data, pollen seasons were identified according to EAACI criteria. A unified monitoring period for patients in AIT trials was created and assessed for feasibility. RESULTS: The analysis revealed a great heterogeneity between the different locations in terms of pattern and length of the examined pollen seasons. Further, we found a fragmentation of pollen seasons in several segments (max. 8) separated by periods of low pollen counts (intercurrent periods). Potential monitoring periods included often many recording days with low pollen exposure (max. 341 days). CONCLUSION: The Mediterranean climate leads to challenging pollen exposure times. Monitoring periods for AIT trials based on existing definitions may include many intermittent days with low pollen concentrations. Therefore, it is necessary to find an adapted pollen season definition as individual solution for each pollen and geographical area.