Bartra, J. (Joan)
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- Validation of a commercial allergen microarray platform for specific immunoglobulin E detection of respiratory and plant food allergens - Improvement of the Elevated Tryptase Criterion to Discriminate IgE- From Non–IgE-Mediated Allergic Reactions - Validation of novel recipes for masking peanuts in double-blind, placebo-controlled food challenges(Elsevier, 2022) Sabaté-Brescó, M. (Marina); Goikoetxea-Lapresa, M.J. (María José); Gastaminza, G. (Gabriel); Moya, C. (Carmen); Blanca-López, N. (Natalia); Alvarado, M.I. (María Isabel); Quan, P.L. (Paola Leonor); Bartra, J. (Joan); D'Amelio-Garofalo, C.M. (Carmen Mariana); Garcia, B.E. (Blanca Esther); Fernandez, J. (Javier); Ferrer-Cardona, M. (Marta); Pascal, M. (Mariona)Background: As the use of multiplex-specific immunoglobulin E (sIgE) detection methods becomes increasingly widespread, proper comparative validation assessments of emerging new platforms are vital. Objective: To evaluate the clinical and technical performance of a newly introduced microarray platform, Allergy Explorer (ALEX) (MacroArray Diagnostics), in the diagnosis of pollen (cypress, grass, olive), dust mite (Dermato- phagoides pteronyssinus), mold (Alternaria alternata), fruit (apple, peach), and nut (walnut, hazelnut and peanut) allergies and to compare it with those of the ImmunoCAP Immuno Solid-phase Allergen Chip (ISAC) 112 microar- ray and the ImmunoCAP singleplex method (ThermoFisher Scientific). Methods: We enrolled 153 patients with allergy and 16 controls without atopy. The sIgE assays were conducted using ISAC112, ALEX version 2 (ALEX2), and ImmunoCAP for whole extracts and major components. Technical validation of ALEX2 was performed by measuring repeatability and interassay, interbatch, and interlaboratory reproducibility. Results: When measured globally (detection by 1 or more allergen components), ALEX2 had adequate sensitivity and specificity for most of the allergens studied, comparable in general with that of ISAC112 (except for olive pol- len and walnut) and similar to that of ImmunoCAP whole extract measurements. Component-by-component analysis revealed comparable results for all techniques, except for Ole e 1 and Jug r 3, in both ISAC112 and Immu- noCAP comparisons, and Alt a 1, when compared with ISAC112. Continuous sIgE levels correlate with sIgE by ImmunoCAP. Good reproducibility and repeatability were observed for ALEX2. Conclusion: ALEX2 has sound technical performance and adequate diagnostic capacity, comparable in general with that of ISAC112 and ImmunoCAP.
- Biomarkers predicting the controller dose of omalizumab in patients with chronic spontaneous urticaria(Blackwell Scientific Publications, 2024) Testera-Montes, A. (A.); Torres-Jaén, M.J. (María Josefa); Eguiluz-Gracia, I. (I.); Vega-Chicote, J.M. (J. M.); Zubiaga-Fernandez, L. (L.); Bartra, J. (Joan); Gómez-Pérez, F. (Francisca); Rondon, C. (C.); Perez-Sanchez, N. (N.); Ferrer-Cardona, M. (Marta)Background: Clinical trials showed the efficacy of 300 mg/4 weeks of omalizumab (OMA) during 6 months in patients with severe chronic spontaneous urticaria (CSU). Nevertheless, in real life, many patients require higher doses and/or longer treatment. This study assesses the real-life performance of OMA in severe CSU and identifies factors associated with the response. Methods: CSU patients eligible for OMA were recruited prospectively. Clinical data and a blood test were collected before OMA initiation. Urticaria Activity Score 7 (UAS7) was calculated at baseline and every 3 months during OMA treatment. CSU control was defined as UAS7 <7 points. This work was partially sponsored by OMA manufacturer. Results: Eighty-nine adults (19.1% males) with severe CSU were recruited. Median duration of CSU prior to OMA initiation was 2 years, and median severity by UAS7 at baseline was 24 points (range 10-42 points). OMA controlled 94.4% of patients, but 17.9% of responders required doses >300 mg/4 weeks. A blood basophil count >20 cells/μL (OR 13.33; 95% CI 3.32-52.63; p < .001) and the absence of hypothyroidism (OR 3.65; 95% CI 0.78-16.95; p = .099) were identified as predictive factors to achieve control with 300 mg/4 weeks. Twelve patients were able to stop OMA during the study (responders in remission, RR). RR had received OMA for a median of 29 months (12-53 months). Conversely, 32 patients had been on OMA for >29 months at the end of the study (active responders, AR). AR had received OMA for a median of 45 months (30-100 months). There were no significant differences in clinical or analytical factors between RR and AR patients. Conclusions: Low blood basophil count and the presence of hypothyroidism might serve as biomarkers for the controller dose of OMA in severe CSU patients.
- Psychometric properties of the Spanish version of the once-daily Urticaria Activity Score (UAS) in patients with chronic spontaneous urticaria managed in clinical practice (the EVALUAS study)(Springer Science and Business Media LLC, 2019) Labrador-Horrillo, M. (Moises); Ortiz-de-Frutos, J. (Javier); Silvestre, J.F. (Juan Francisco); Sastre, J. (Joaquín); Velasco, M. (Manuel); Bartra, J. (Joan); Jauregui, I. (I.); Gimenez-Arnau, A. (Ana); Ballesteros, C. (Cristina); Ferrer-Cardona, M. (Marta); Valero-Santiago, A. (Antonio)Background: The daily diary Urticaria Activity Score (UAS) and its weekly score (UAS7) are widely used to assess signs and symptoms in patients with chronic spontaneous urticaria (CSU). The objective of this study was to assess the psychometric properties of a Spanish version of the once-daily UAS. Methods: Observational study in patients ≥18 years old receiving usual care for CSU (daily or almost daily occurrence of generalized hives or angioedema for ≥6 weeks). Patients were included consecutively and completed the UAS, EQ5D, and the Chronic Urticaria Quality of Life scale (CU-Q2oL) at two study visits 6 weeks apart. On each occasion, the UAS was completed once-daily for 7 consecutive days to be able to calculate the UAS7 score. Psychometric properties of reliability, construct validity, and responsiveness were assessed. The Minimal Important Difference (MID) was estimated for the UAS7 using anchor- and distribution-based approaches. Results: Data from 166 patients was available for analysis (mean age 49 years, 65.7% female). Floor (5.4% of patients with the lowest possible score) and ceiling (1.2%) effects were low; 15% of patients had missing values. Internal consistency and test-retest reliability were good (Cronbach’s alpha of 0.83 and an ICC of 0.84, respectively). Convergent validity was demonstrated through the pattern of correlations with the EQ-5D and CU-Q2oL and known groups’ validity was demonstrated by the instrument’s ability to discriminate between patients with different overall levels of urticaria severity, with between-group effect-sizes (ES) ranging from 0.36 to 1.19. The UAS7 proved responsive to change with effect sizes ranging from 0.3 to 1.52 in patients reporting improvement or deterioration in overall urticaria status. The MID for the UAS7 score was estimated at 7–8 points, on a scale of 0–42. Conclusions: The Spanish version of the UAS score has demonstrated a robust psychometric performance in patients with CSU managed in conditions of usual care. It can therefore be considered a suitable instrument to assess disease activity in clinical practice in Spanish-speaking patients. The Spanish version’s reliability and validity are similar to those reported for other language versions of the once- and twice-daily variants of the UAS.
- Effect of antihistamine up-dosing in chronic urticaria(ESMON Publicidad, 2011) Sastre, J. (Joaquín); Davila, I. (I.); Bartra, J. (Joan); Mullol, J. (J.); Jauregui, I. (I.); Montoro, J. (J.); Ferrer-Cardona, M. (Marta); Valero-Santiago, A. (Antonio); Cuvillo, A. (A.) delChronic urticaria has an important impact upon patient quality of life, and no treatment has yet been developed capable of effectively controlling the disease. The most recent guidelines recommend the use of non-sedating antihistamines at high doses as second-step therapy before resorting to other treatments. The present review examines the studies published to date on the use of H1 antihistamines at doses higher than those indicated as therapeutic doses in chronic urticaria. Most of the studies report no significant differences among the studied doses – only a tendency towards increased response on elevating the dose.There are no clinically well designed, randomized double-blind trials comparing efficacy between therapeutic doses and doses higher than those indicated in the corresponding Summary of Product Characteristics. Likewise, there are insufficient data to conduct a meta-analysis and thus classify the degree of evidence of the few available studies, which moreover present contradictory results. At present, the prescription of high-dose H1 antihistamines is based only on experts opinion. However, considering the high safety profile of these drugs, it would be a good option to evaluate their efficacy at high doses, before moving on to other therapeutic steps.
- Identification and Characterization of IgE-Reactive Proteins and a New Allergen (Cic a 1.01) from Chickpea (Cicer arietinum)(2020) Zoccatelli, G. (Gianni); Brockmeyer, J. (Jens); Blanca, M. (Miguel); Torres, M. (María); Goikoetxea-Lapresa, M.J. (María José); Kulkarni, A. (Anuja); García-Moral, A. (Alba); Blanca-López, N. (Natalia); Mahler, V. (Vera); Spiric, J. (Jelena); Jamin, A. (Annette); Wangorsch, A. (Andrea); Bartra, J. (Joan); Scheurer, S. (Stephan); Gomez, P. (Paqui); Vieths, S. (Stefan); Toda, M. (Masako); Bräcker, J. (Julia); Ferrer-Cardona, M. (Marta)Scope: Chickpea (Cicer arietinum) allergy has frequently been reported particularly in Spain and India. Nevertheless, chickpea allergens are poorly characterized. The authors aim to identify and characterize potential allergens from chickpea. Methods and Results: Candidate proteins are selected by an in silico approach or immunoglobuline E (IgE)-testing. Potential allergens are prepared as recombinant or natural proteins and characterized for structural integrity by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), circular dichroism (CD)-spectroscopy, and mass spectrometry (MS) analysis. IgE-sensitization pattern of Spanish chickpea allergic and German peanut and birch pollen sensitized patients are investigated using chickpea extracts and purified proteins. Chickpea allergic patients show individual and heterogeneous IgE-sensitization profiles with extracts from raw and boiled chickpeas. Chickpea proteins pathogenesis related protein family 10 (PR-10), a late embryogenesis abundant protein (LEA/DC-8), and a vicilin-containing fraction, but not 2S albumin, shows IgE reactivity with sera from chickpea, birch pollen, and peanut sensitized patients. Remarkably, allergenic vicilin, DC-8, and PR-10 are detected in the extract of boiled chickpeas. Conclusion: Several IgE-reactive chickpea allergens are identified. For the first time a yet not classified DC-8 protein is characterized as minor allergen (Cic a 1). Finally, the data suggest a potential risk for peanut allergic patients by IgE cross-reactivity with homologous chickpea proteins.
- Is Microarray Analysis Really Useful and Sufficient to Diagnose Nut Allergy in the Mediterranean Area?(Esmon Publicidad, 2016) Goikoetxea-Lapresa, M.J. (María José); Parra, A. (A.); Moya, C. (Carmen); Díaz-Perales, A. (Araceli); Blanca-López, N. (Natalia); Alvarado, M.I. (María Isabel); Alonso, M.D. (María Dolores); Martinez-Aranguren, R. (R.); Bartra, J. (Joan); Gamboa-Setién, P. (Pedro); Terrados, S. (Soledad); D'Amelio-Garofalo, C.M. (Carmen Mariana); Garcia, B.E. (Blanca Esther); Fernandez, J. (Javier); Gómez-Pérez, F. (Francisca); Villalba, M. (Mayte); Sanz, M.L. (María Luisa); González, E. (Eloína); Feo-Brito, F. (Francisco)Background: Component-based diagnosis on multiplex platforms is widely used in food allergy but its clinical performance has not been evaluated in nut allergy. Objective: To assess the diagnostic performance of a commercial protein microarray in the determination of specific IgE (sIgE) in peanut, hazelnut, and walnut allergy. Methods: sIgE was measured in 36 peanut-allergic, 36 hazelnut-allergic, and 44 walnut-allergic patients by ISAC 112, and subsequently, sIgE against available components was determined by ImmunoCAP in patients with negative ISAC results. ImmunoCAP was also used to measure sIgE to Ara h 9, Cor a 8, and Jug r 3 in a subgroup of lipid transfer protein (LTP)-sensitized nut-allergic patients (positive skin prick test to LTP-enriched extract). sIgE levels by ImmunoCAP were compared with ISAC ranges. Results: Most peanut-, hazelnut-, and walnut-allergic patients were sensitized to the corresponding nut LTP (Ara h 9, 66.7%; Cor a 8, 80.5%; Jug r 3, 84% respectively). However, ISAC did not detect sIgE in 33.3% of peanut-allergic patients, 13.9% of hazelnut-allergic patients, or 13.6% of walnut-allergic patients. sIgE determination by ImmunoCAP detected sensitization to Ara h 9, Cor a 8, and Jug r 3 in, respectively, 61.5% of peanut-allergic patients, 60% of hazelnut-allergic patients, and 88.3% of walnut-allergic patients with negative ISAC results. In the subgroup of peach LTP–sensitized patients, Ara h 9 sIgE was detected in more cases by ImmunoCAP than by ISAC (94.4% vs 72.2%, P<.05). Similar rates of Cor a 8 and Jug r 3 sensitization were detected by both techniques. Conclusions: The diagnostic performance of ISAC was adequate for hazelnut and walnut allergy but not for peanut allergy. sIgE sensitivity against Ara h 9 in ISAC needs to be improved.
- Omalizumab efficacy in cases of chronic spontaneous urticaria is not explained by the inhibition of sera activity in effector cells(Nature Publishing Group, 2017) Serrano-Candelas, E. (Eva); Gastaminza, G. (Gabriel); Audicana, M.T. (María T.); Martínez-Aranguren, R. (Rubén); Bartra, J. (Joan); Martín, M. (Margarita); Algorta, J. (Jaime); Vega, O. (Olga); Ferrer-Cardona, M. (Marta); Nuñez-Cordoba, J.M. (Jorge M.); Valero-Santiago, A. (Antonio)Omalizumab (OmAb) is a humanized anti-IgE antibody approved for the treatment of chronic spontaneous urticaria (CSU). OmAb's mechanism of action is known to include actions on free IgE and on pre-bound IgE. However, OmAb is equally and rapidly effective against autoimmune and non-autoimmune urticaria where IgE involvement is not clear, suggesting the involvement of additional mechanisms of action. In this study, we sought to investigate the ability of OmAb to inhibit mast cell and basophil degranulation induced by sera from CSU patients. For this purpose, we performed a comparison between the in vitro incubation of sera from CSU patients treated with OmAb and the in vivo administration of OmAb in a clinical trial. We found that OmAb added in vitro to sera from CSU patients did not modify the ability of the sera to induce cell degranulation. Similarly, the sera from patients treated with OmAb in the context of the clinical trial who had a good clinical outcome maintained the capacity to activate mast cells and basophils. Thus, we conclude that the beneficial activity of OmAb does not correlate with the ability of patient sera to induce cell degranulation.
- Validation of a commercial allergen microarray platform for specific immunoglobulin E detection of respiratory and plant food allergens(2022) Sabaté-Brescó, M. (Marina); Goikoetxea-Lapresa, M.J. (María José); Gastaminza, G. (Gabriel); Moya, C. (Carmen); Blanca-López, N. (Natalia); Alvarado, M.I. (María Isabel); Quan, P.L. (Paola Leonor); Bartra, J. (Joan); D'Amelio-Garofalo, C.M. (Carmen Mariana); Garcia, B.E. (Blanca Esther); Fernandez, J. (Javier); Ferrer-Cardona, M. (Marta); Pascal, M. (Mariona)Background As the use of multiplex-specific immunoglobulin E (sIgE) detection methods becomes increasingly widespread, proper comparative validation assessments of emerging new platforms are vital. Objective To evaluate the clinical and technical performance of a newly introduced microarray platform, Allergy Explorer (ALEX) (MacroArray Diagnostics), in the diagnosis of pollen (cypress, grass, olive), dust mite (Dermatophagoides pteronyssinus), mold (Alternaria alternata), fruit (apple, peach), and nut (walnut, hazelnut and peanut) allergies and to compare it with those of the ImmunoCAP Immuno Solid-phase Allergen Chip (ISAC) 112 microarray and the ImmunoCAP singleplex method (ThermoFisher Scientific). Methods We enrolled 153 patients with allergy and 16 controls without atopy. The sIgE assays were conducted using ISAC112, ALEX version 2 (ALEX2), and ImmunoCAP for whole extracts and major components. Technical validation of ALEX2 was performed by measuring repeatability and interassay, interbatch, and interlaboratory reproducibility. Results When measured globally (detection by 1 or more allergen components), ALEX2 had adequate sensitivity and specificity for most of the allergens studied, comparable in general with that of ISAC112 (except for olive pollen and walnut) and similar to that of ImmunoCAP whole extract measurements. Component-by-component analysis revealed comparable results for all techniques, except for Ole e 1 and Jug r 3, in both ISAC112 and ImmunoCAP comparisons, and Alt a 1, when compared with ISAC112. Continuous sIgE levels correlate with sIgE by ImmunoCAP. Good reproducibility and repeatability were observed for ALEX2. Conclusion ALEX2 has sound technical performance and adequate diagnostic capacity, comparable in general with that of ISAC112 and ImmunoCAP.
- Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food-A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA²LEN position paper(Wiley-Blackwell, 2022) Brockow, K. (Knut); Arasi, S. (Stefania); Ebisawa, M. (Motohiro); Galvin, A.D. (Audrey Dunn); Arshad, H. (Hasan); Cianferoni, A. (Antonella); Bousquet, J.J. (Jean J.); Bindslev-Jensen, C. (Carsten); Angier, E. (Elizabeth); Custovic, A. (Adnan); Bégin, P. (Philippe); Dörr, T. (Tamara); Jong, N. (Nicolette) de; Cork, M.J. ( Michael J.); Aberer, W. (Werner); Alvaro, M. (Montserrat); Bartra, J. (Joan); Deschildre, A. (Antoine); Beck, L. (Lisa); Deleanu, D. (Diana); Giacco, S. (Stefano) del; Zuberbier, T. (Torsten); Fernández-Rivas, M. (Montserrat); Bush, A. (Andrew); Bislimovska, J. (Jovanka); Darsow, U. (Ulf); Ballmer-Weber, B. (Barbara); Ferrer-Cardona, M. (Marta)Background: Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as "may contain traces of" is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods: MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results: In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion: Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement "this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product" for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.