A Prospective Study of Costs Associated With the Evaluation of Allergic Reactions to Radiological Contrast Media.

BACKGROUND AND OBJECTIVE: The prevalence of hypersensitivity reactions to radiological contrast media (RCM) is increasing owing to the improved performance of diagnostic and therapeutic tests that require RCMs. Objective: We carried out a year-long real-life observational study to prospectively evaluate patients referred to the allergy department from primary care, the emergency department, and other specialties with suspected moderate-to-severe RCM hypersensitivity reactions. METHODS: To study the costs of evaluating RCM hypersensitivity reactions, we systematically recorded direct and indirect costs. RESULTS: Sixty-nine patients with previous reactions to RCM were evaluated in the allergy department from June 1, 2017, to May 31, 2018.Total direct health care costs were €10 715.84, with a mean (SD) cost per patient of €155.30 (77.08). Specifically, direct non-health care costs reached €1605.42 (mean, €23.27 [41.14]), and indirect costs were €6490.85 (mean, €94.07 [110.61]). In summary, the total cost was €18 812.11, that is, a mean cost of €272.64 (164.77). CONCLUSION: Our study shows that the costs of an elective evaluation of hypersensitivity reactions to RCM are low, thus confirming that correct and safe management of affected patients are cost-effective. Therefore, our efforts should be directed toward ensuring the necessary logistics.

A Prospective Study of Costs Associated With the Evaluation of Allergic Reactions to Radiological Contrast Media

Background: The prevalence of hypersensitivity reactions to radiological contrast media (RCM) is increasing owing to the improved performance of diagnostic and therapeutic tests that require RCMs. Objective: We carried out a year-long real-life observational study to prospectively evaluate patients referred to the allergy department from primary care, the emergency department, and other specialties with suspected moderate-to-severe RCM hypersensitivity reactions. Methods: To study the costs of evaluating RCM hypersensitivity reactions, we systematically recorded direct and indirect costs. Results: Sixty-nine patients with previous reactions to RCM were evaluated in the allergy department from June 1, 2017, to May 31, 2018.Total direct health care costs were €10 715.84, with a mean (SD) cost per patient of €155.30 (77.08). Specifically, direct non–health care costs reached €1605.42 (mean, €23.27 [41.14]), and indirect costs were €6490.85 (mean, €94.07 [110.61]). In summary, the total cost was €18 812.11, that is, a mean cost of €272.64 (164.77). Conclusions: Our study shows that the costs of an elective evaluation of hypersensitivity reactions to RCM are low, thus confirming that correct and safe management of affected patients are cost-effective. Therefore, our efforts should be directed toward ensuring the necessary logistics (AU)

Antecedentes: La prevalencia de reacciones de hipersensibilidad a los medios de contraste radiológico (MCR) está aumentando debido al incremento en la realización de pruebas diagnósticas y terapéuticas que requieren MCR. Objetivo: Hemos realizado un estudio observacional de un año de duración para evaluar prospectivamente a los pacientes remitidos al Servicio de Alergología con sospecha de reacciones moderadas a graves por hipersensibilidad a MCR.Métodos: Para estudiar los costes de la evaluación de la hipersensibilidad a MCR, se registraron sistemáticamente los costes directos e indirectos. Resultados: Se evaluaron 69 pacientes con reacciones previas a MCR remitidos al Servicio de Alergología desde el 1 de junio de 2017 hasta el 31 de mayo de 2018. Los costes sanitarios directos totales fueron de 10.715,84 €, con un coste medio por paciente de 155,30 € ± 77,08. En concreto, los costes directos no sanitarios alcanzaron los 1.605,42 € (media 23,27 € ± 41,14 €) y los costes indirectos fueron de6.490,85 € (media 94,07 € ± 110,61 €). En resumen, el coste total fue de 18.812,11 €, lo que supone un coste medio de 272,64 ± 164,77 €. Conclusiones: Nuestro estudio refleja que los costes de una evaluación electiva de hipersensibilidad a MCR son bajos. Este hecho reafirma que el manejo correcto y seguro de estos pacientes podría ser rentable, por lo que nuestros esfuerzos deben estar dirigidos a implementar la logística necesaria (AU)

A Specialized Therapeutic Approach to Chronic Urticaria Refractory to H1-Antihistamines Improves Disease Burden: The Spanish AWARE Experience.

OBJECTIVE: During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice. METHODS: We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age ≥18 years and H1-AH-refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain. RESULTS: The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first- and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%. CONCLUSION: H1-AH-refractory CU in Spain is characterized by absence of control of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients' QOL.

Dupilumab: A Review of Present Indications and Off-Label Uses.

Recent advances in our understanding of T2 inflammation have revealed more diseases in which T2 inflammation is involved. Dupilumab is a recently developed monoclonal antibody that blocks signaling of IL-4 and IL-13, both of which are crucial cytokines in the T2 response. New possible indications are increasingly explored and include skin diseases, such as prurigo nodularis, nummular eczema, allergic contact dermatitis, chronic hand eczema, spontaneous chronic urticaria, bullous pemphigoid, alopecia areata, and Netherton syndrome, as well as respiratory diseases, such as allergic bronchopulmonary aspergillosis, chronic eosinophilic pneumonia, and allergic rhinitis. In addition, eosinophilic gastrointestinal disorders, particularly eosinophilic esophagitis, and food allergy, are also research fields of interest. Here, we review published data and clinical trials examining the use of dupilumab in these disorders.

Dupilumab: A Review of Present Indications and Off-Label Uses

Recent advances in our understanding of T2 inflammation have revealed more diseases in which T2 inflammation is involved. Dupilumabis a recently developed monoclonal antibody that blocks signaling of IL-4 and IL-13, both of which are crucial cytokines in the T2 response.New possible indications are increasingly explored and include skin diseases, such as prurigo nodularis, nummular eczema, allergic contactdermatitis, chronic hand eczema, spontaneous chronic urticaria, bullous pemphigoid, alopecia areata, and Netherton syndrome, as wellas respiratory diseases, such as allergic bronchopulmonary aspergillosis, chronic eosinophilic pneumonia, and allergic rhinitis. In addition,eosinophilic gastrointestinal disorders, particularly eosinophilic esophagitis, and food allergy, are also research fields of interest. Here, wereview published data and clinical trials examining the use of dupilumab in these disorders (AU)

Los recientes avances en la comprensión de la inflamación T2 han mostrado otras enfermedades en las que la inflamación T2 está involucrada.El dupilumab es un anticuerpo monoclonal recientemente desarrollado que bloquea la transmisión de señales de IL-4 e IL-13, dos citocinasesenciales en la respuesta T2. Se están investigando posibles nuevas indicaciones, que incluyen enfermedades cutáneas, como el prurigonodular, eccema numular, dermatitis alérgica de contacto, eccema crónico de manos, urticaria crónica espontánea, penfigoide ampolloso,alopecia areata y síndrome de Netherton, así como enfermedades respiratorias, como la aspergilosis broncopulmonar alérgica, neumoníaeosinofílica crónica y rinitis alérgica. Además, las enfermedades gastrointestinales eosinofílicas, en particular la esofagitis eosinofílica y laalergia alimentaria, también constituyen áreas de investigación. En esta publicación se revisan los datos publicados y los ensayos clínicosque evalúan el uso de dupilumab en estas entidade

A Specialized Therapeutic Approach to Chronic Urticaria Refractory to H1-Antihistamines Improves Disease Burden: The Spanish AWARE Experience

Objective: During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice.Methods: We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age ≥18 years and H1-AH–refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain.Results: The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first- and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%.Conclusions: H1-AH–refractory CU in Spain is characterized by absence of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients’ QOL (AU)

Objetivo: El estudio AWARE evalúa la actividad de la enfermedad, la calidad de vida (CV) del paciente y los patrones de tratamientoen pacientes con urticaria crónica (UC) refractarios a antihistamínicos H1 (AH-H1) en práctica clínica durante el primer año del estudio.Métodos: Estudio observacional, prospectivo (24 meses), internacional y multicéntrico. Pacientes ≥18 años con diagnóstico de UC refractariosa AH-H1 (>2 meses). En cada visita, los pacientes completaron cuestionarios para evaluar la carga de la enfermedad (Urticaria Control Test[UCT]), actividad de la enfermedad (7 day-Urticaria Activity Score [UAS7]), CV (Dermatology Life Quality index [DLQI], Chronic UrticariaQuality of Life Questionnaire [CU-Q2oL], Angioedema Quality of Life [AE-QOL]). Presentamos datos españoles.Resultados: Se incluyeron 270 pacientes evaluables (73,3% mujeres, edad media [DE] 48,9 [14,7] años). Al inicio del estudio, al 89,3%se le prescribió un tratamiento para la UC. Después de 1 año, los tratamientos de primera/segunda línea tendieron a disminuir y la tercera línea a aumentar. El 47,0% de los pacientes experimentaron angioedema al inicio del estudio, siendo del 11,8% al cabo de 1 año. Lamedia (DE) de AE-QOL pasó de 45,2 (28,7) a 24,0 (25,8). La media (DE) de UCT pasó de 7,0 (4,5) a 12,1 (4,1). Según UAS7, el 38,2% depacientes reportaron ausencia de ronchas y prurito en los últimos 7 días al año frente al 8,3% al inicio. El DLQI medio (DE) pasó de 8,0 (7,4)a 2,8 (4,6). En la visita de 1 año, el porcentaje de pacientes que reportaron un impacto en la CV alto/muy alto pasó del 29,9% al 9,6%.Conclusiones: Los pacientes españoles con UC refractarios a AH-H1 presentan una falta de control de la sintomatología con un importanteimpacto en su CV. El seguimiento continuo de los pacientes con urticaria crónica espontánea y las terapias de tercera línea han demostradouna tendencia a reducir la carga de la enfermedad y a mejorar la CV de los pacientes (AU)

A Comprehensive Prospective Study of the Costs Associated With Evaluation of ß-Lactam Allergy.

BACKGROUND AND OBJECTIVE: Being labeled as allergic to penicillin (unverified ß-lactam allergy) can result in patients receiving broader-spectrum antibiotics than necessary that may be more toxic, less effective, and/or more expensive than alternative options. Objective: We aimed to evaluate the real costs of evaluating ß-lactam allergy. METHODS: We performed a prospective real-life observational study designed to evaluate all adult patients who consulted for suspected ß-lactam allergy over a 1-year period. Direct and indirect costs were systematically recorded. Direct health costs were calculated based on the number of visits and all additional and diagnostic tests performed, direct nonhealth costs based on the number of visits and the distance from their homes to the Allergy Department, and indirect costs based on absenteeism. RESULTS: A total of 296 patients with suspected allergy to ß-lactams were evaluated in our outpatient clinic from June 1, 2017 to May 31, 2018. Total direct health care costs were €28 176.70, with a mean (SD) cost of €95.19 (37.20). Direct nonhealth costs reached €6551.73, that is, €22.13 (40.44) per patient. Indirect health costs reached €20 769.20, with a mean of €70.17 (127.40). In summary, the total cost was €55 497.63, that is, a cost per patient of €187.49 (148.14). CONCLUSIONS: When all possible costs are taken into account, the evaluation of ß-lactam allergy is not expensive and can reduce future expense arising from unnecessary use of more expensive and less effective antibiotics.

Adherence to Anaphylaxis Guidelines: Real-World Data From the Emergency Department of a Tertiary Hospital.

BACKGROUND AND OBJECTIVE: Few studies have evaluated adherence to anaphylaxis guidelines in emergency departments (EDs). Objective: The objective of this study was to evaluate adherence to anaphylaxis guidelines in the ED of a tertiary hospital. METHODS: Medical records of patients attended in the ED of University Hospital of Salamanca, Spain were reviewed. Those patients fulfilling the anaphylaxis criteria proposed by the NIAID/FAAN were selected. RESULTS: During a 1-year period, we identified 89 patients (74 adults and 15 children). The anaphylactic reaction was moderate in 65% of adults, severe in 34%, and very severe in 1%. In children, all reactions were moderate. Fewer than half of the patients (42%) received adrenaline in the ED; this was administered intramuscularly in only 19% of cases. As for the severity of the reaction, 65% of patients with moderate reactions and 42% with severe reactions were not treated with adrenaline. At discharge from the ED, an adrenaline auto-injector was recommended to only 5.6% of patients. Fifty-two percent of patients received a documented allergy referral (57% adults vs 27% children, P=.047), 29% instructions about avoidance of triggers (31% adults vs 20% children, NS), and 51% written instructions for recognition of anaphylaxis warning signs (41% adults vs 100% children, P<.001). CONCLUSIONS: The results of the study show a large discrepancy between recommendations in guidelines and management of anaphylaxis in the ED. Additional training efforts are needed to improve the treatment of patients with anaphylactic reactions.

Performance in real life of the European Network on Drug Allergy algorithm in immediate reactions to beta-lactam antibiotics.

European Network on Drug Allergy (ENDA) has proposed an algorithm for diagnosing immediate beta-lactam (BL) allergy. We evaluated its performance in real life. During 1994-2014, 1779 patients with suspected immediate reactions to BL were evaluated following ENDA's short diagnostic algorithm. Five hundred and nine patients (28.6%) were diagnosed of BL hypersensitivity. Of them, 457 (25.7%) were at first evaluation [403 by skin tests (ST), 12 by positive IgE and 42 by controlled provocation tests (CPT)]. At second evaluation (SE), 52 additional patients (10.2% of allergic patients) were diagnosed, [50 (2.8%) by ST and 2 (0.1%) by CPT]. Time between reaction and study was significantly longer in patients diagnosed at SE (median 5 vs 42 months; IQR 34 vs 170; P < 0.0001). Anaphylaxis was significantly associated with a diagnosis at SE. European Network on Drug Allergy/EAACI protocol was appropriate and safe when evaluating BL immediate reactions. Re-evaluation should be performed, particularly when anaphylaxis and long interval to diagnosis are present.

Allergic contact dermatitis due to sensitisation to sunscreen in two infants

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Polymorphisms of the IL12B, IL1B, and TNFA Genes and Susceptibility to Asthma

Background: Asthma is one of the most common chronic inflammatory diseases in developed countries. Susceptibility to asthma is associated with interaction between multiple genes and environmental factors. Several cytokines play a major role in the pathophysiology of the disease. Objective: We analyzed the distribution of cytokine gene polymorphisms in a group of patients with asthma and a control group in order to determine the effect of these variants, or their combinations, on the development of clinical phenotypes. Methods: We genotyped 22 single-nucleotide polymorphisms (SNPs) corresponding to 13 cytokine genes (IFNG, IL1A, IL1B, IL1R1, IL1RN, IL2, IL4, IL4R, IL6, IL10, IL12B, TGFB1, and TNFA) in 376 individuals (219 asthmatic patients and 157 controls). Genetic association was evaluated using genotype and allele models for different asthma phenotypes. Gene–gene interactions were explored using multifactor dimensionality reduction. Results: Genotype AC of IL12B -1188 was associated with the presence of asthma. A significant association was detected between 2 SNPs analyzed in TNFA (–308 and –238) and atopic asthma and severe-persistent asthma. The IL1B TT haplotype (3962T and –511T) was also associated with atopy and moderate-persistent asthma. Conclusion: Our data show that the presence of SNPs in IL12B, TNFA, and IL1B was significantly associated with asthma, atopy, and severity of asthma. We also highlight the importance of genetic context, haplotype, and gene–gene interaction analysis in genetic association studies (AU)

Introducción: El asma es una de las enfermedades inflamatorias crónicas más frecuentes en los países desarrollados. La susceptibilidad al asma viene determinada por la interacción entre múltiples genes y factores ambientales. En la fisiopatología de esta enfermedad las citocinas desempeñan un papel importante. Objetivo: El objetivo de este estudio fue analizar la distribución de varios polimorfismos en genes de citocinas en un grupo de pacientes con asma y en un grupo control para determinar la influencia que estas variantes, o sus combinaciones génicas, desempeñan en los fenotipos clínicos. Métodos: Se analizaron 22 SNP correspondientes a 13 genes codificantes de citocinas (IFNG, IL1A, IL1B, IL1R1, IL1RN, IL2, IL4, IL4R, IL6, IL10, IL12B, TGFB1, y TNFA) en 376 individuos, 219 sujetos asmáticos y 157 controles. Las asociaciones genéticas fueron evaluadas empleando modelos genotípicos y alélicos para los distintos fenotipos de asma. Las interacciones gen-gen se analizaron mediante la plataforma Multifactor Dimensionality Reduction Platform (MDR). Resultados: El genotipo AC de IL12B -1188 se asoció con la presencia de asma. Dos SNP analizados en el gen TNFA (TNFA-308, and TNFA-238) mostraron una asociación significativa con el asma atópica y con la presencia de asma persistente grave. El haplotipo TT de IL1B (3962T y -511T) también se asoció con la presencia de atopia y con asma persistente moderada. Conclusiones: Nuestros datos muestran que la presencia de estos SNP en los genes IL12B, TNFA y IL1B se asocian significativamente con el asma, la atopia y con la gravedad del asma. También recalcamos la importancia del contexto génico, haplotipos e interacciones gen-gen en los estudios de asociación génica (AU)