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Background: Mechanisms triggering the pathogenesis of chronic spontaneous urticaria (CSU) have been identified as type I autoallergic (which is associated with IgE antibodies against autoantigens) and type IIb autoimmune (which is driven by autoantibodies to FceR1 and/or IgE). Objective: Our aim was to define presumptive endotypes in patients with CSU by using tests amenable to use in routine clinical practice. Methods: A retrospective analysis of the medical records of 394 patients with CSU with or without chronic inducible urticaria or angioedema was performed. Patients were assigned to 1 of 4 groups as follows: (1) type I endotype of CSU, if they presented at least 1 of the following: allergic disease, total IgE level of at least 40UI/mL, and positive result of skin tests to inhalant allergen(s), (2) type IIb endotype of CSU, if they presented at least 1 of following: autoimmune disease, low total IgE level less than 40 IU/mL, positive autologous serum skin test result, positive for antinuclear antibodies in a titer of at least 1:160, and elevated level of anti-thyroid peroxidase, (3) overlap of type I/type IIb endotypes of CSU, if they presented with at least 1 marker of both type I and type IIb, and (4) non-type I/type IIb endotype of CSU, if they presented with none of the markers of type I or type IIb. Results: The mean age at onset of symptoms was 34 years; 82.2% of those with CSU were female, and angioedema and chronic inducible urticaria were found in 74.8% and 31.9% of patients, respectively. Of the patients with CSU, 38% presented with the type I endotype and 51% presented with type I/type IIb overlap, whereas 9% presented with the type IIb endotype and 2% presented with the non-type I/type IIb endotype. Eosinopenia was associated with type IIb and type I/type IIb overlap as opposed to the type I and non-type I/type IIb endotypes (P = .02). Conclusions: Most patients with CSU presented with features of the type 1 (autoallergic) endotype, whether associated with type IIb (autoimmune) endotype or not.

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Introdução: A urticária crônica espontânea é caracterizada por lesões máculo-papulares eritematosas, associadas a prurido e angioedema, que não possui estímulo externo reconhecido e de difícil controle. A primeira e a segunda linha terapêutica, disponibilizadas pelo Sistema Único de Saúde, não apresentam resultados significativos, os quais se tornam refratários. O omalizumabe, considerado terceira linha terapêutica e que não é amplamente disponibilizado pelo Sistema Único de Saúde, pode apresentar resultado significativo na interrupção dos sintomas da doença. Objetivo: O presente estudo tem como objetivo avaliar pacientes com urticária crônica espontânea que usaram ou estão em uso de omalizumabe. Métodos: Trata-se de um estudo observacional transversal do tipo série de casos, cuja análise foi feita através dos prontuários, com população de 34 pacientes com urticária crônica espontânea submetidos ao tratamento com omalizumabe no Instituto de Olhos de Santa Catarina (IOSC). Resultados: Constatou-se no estudo que a maioria dos pacientes com urticária crônica espontânea em uso de omalizumabe é constituída do sexo feminino (76,5%) e idade média de 41 anos. A doença mais associada à urticária crônica espontânea foi depressão (38,2%). O sucesso do tratamento com omalizumabe é medido pelo questionário UAS7 (Urticaria Activity Score), o qual, segundo os dados dos prontuários, todos os pacientes apresentavam resultado maior que 35 pontos antes do uso da medicação, e 32 conseguiram alcançar um índice de 0 após o uso do omalizumabe, variando apenas no tempo de tratamento. Conclusão: A urticária crônica espontânea é uma doença que não tem cura e possui alta refratariedade, mas pode ter seus sintomas reduzidos, principalmente com o uso do omalizumabe, que se mostrou eficiente nos casos analisados.

Introduction: Chronic spontaneous urticaria is a disease characterized by erythematous maculopapular eruption, associated with itching and angioedema, that has no recognized external stimulus and is difficult to control. First- and second-line treatments, available through the Brazilian Unified Health System, do not yield meaningful results, and patients become refractory. Omalizumab, considered a third-line treatment and not widely available through the Brazilian Unified Health System, may yield meaningful results in halting disease symptoms. Objective: To evaluate patients with chronic spontaneous urticaria who have used or are using omalizumab. Methods: We conducted a cross-sectional case series observational study with a review of the medical records of 34 patients with chronic spontaneous urticaria treated with omalizumab at the Eye Institute of Santa Catarina, south of Brazil. Results: Most patients with chronic spontaneous urticaria receiving omalizumab were female (76.5%) with a mean age of 41 years. The disease most commonly associated with chronic spontaneous urticaria was depression (38.2%). Omalizumab treatment success was measured with the Urticaria Activity Score (UAS7). Based on data extracted from the medical records, all 34 patients had a score greater than 35 before treatment. After receiving omalizumab, 32 patients managed to reach a score of 0, differing only in the duration of treatment. Conclusion: Chronic spontaneous urticaria is an incurable, highly refractory disease, but its symptoms can be reduced mainly with the use of omalizumab, which proved to be effective in the cases analyzed here.

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O tratamento das doenças autoimunes com imunobiológicos é uma opção segura na prática clínica. A simultaneidade na ocorrência de doenças imunomediadas em um mesmo indivíduo pode determinar a necessidade da associação dos imunobiológicos para controle dos sintomas e melhora da qualidade de vida dos doentes. Relatamos o caso de uma paciente com artrite reumatoide em uso de etanercepte, que necessitou da associação de omalizumabe para o tratamento de urticária crônica espontânea.

Autoimmune diseases can be safely treated in clinical practice with immunobiologicals. The simultaneous occurrence of multiple immune-mediated diseases in the same individual could require a combination of immunobiologicals to control symptoms and improve quality of life. We report the case of a patient with rheumatoid arthritis who was receiving etanercept and required additional omalizumab for chronic spontaneous urticaria.

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O início da pandemia de COVID-19 foi marcado por incertezas diante do desconhecimento sobre a doença. Uma série de dúvidas relacionadas ao uso de imunobiológicos no contexto da pandemia foi levantada, inclusive em relação ao tratamento com omalizumabe em pacientes com urticária crônica (UC). Este estudo teve como objetivo analisar os dados relacionados à gravidade da COVID-19 e a evolução da urticária em pacientes em terapia com omalizumabe acompanhados por especialistas no Brasil. Foi realizada análise retrospectiva de dados de pacientes com UC tratados com omalizumabe entre julho/2020 e junho/2021 que apresentaram COVID-19. Foram avaliados dados relacionados às características clínicas dos pacientes e evolução da urticária durante a infecção pelo SARS-CoV2. Foram incluídos 28 pacientes em tratamento com omalizumabe, sendo 27 com urticária crônica espontânea (UCE), dos quais 25% tinham alguma urticária induzida associada. A maior parte dos pacientes (71%) estavam utilizando doses quadruplicadas de anti-histamínicos modernos de 2ª geração associados ao omalizumabe. Todos os pacientes estavam com os sintomas controlados. Entre os sintomas apresentados durante a COVID-19, os mais frequentes foram: febre (43%), cefaleia (36%), mal-estar (32%), hipo/anosmia (29%) e tosse (21%). Quatro pacientes foram hospitalizados, um deles em unidade de terapia intensiva. Um paciente relatou piora dos sintomas da UC durante a COVID-19. Cinco (18%) pacientes apresentaram piora dos sintomas da UC após a resolução da COVID-19. Todos os pacientes se recuperaram da COVID-19 sem sequelas graves. O OMA não pareceu aumentar o risco de COVID-19 grave e poderia ser usado com segurança em pacientes com UC.

The beginning of the COVID-19 pandemic was marked by uncertainty due to lack of knowledge about the disease. Questions were raised about the use of immunobiologicals in the pandemic context, including omalizumab for patients with chronic urticaria (UC). This study assessed COVID-19 severity and the clinical course of urticaria in Brazilian patients on omalizumab therapy who were monitored by specialists. We retrospectively analyzed data from chronic urticaria patients treated with omalizumab between July, 2020 and June, 2021 who presented with COVID- 19. Clinical characteristics and the course of urticaria during SARS-CoV2 infection were analyzed. The sample consisted of 28 patients treated with omalizumab, 27 of whom had chronic spontaneous urticaria (UCE) and 25% of whom had associated chronic inducible urticaria. Most of the patients (71%) were using quadruple doses of second-generation antihistamines associated with omalizumab. The symptoms of all patients were controlled. The most frequent symptoms during COVID-19 were: fever (43%), headache (36%), malaise (32%), hypo/anosmia (29%) and cough (21%). Four patients were hospitalized, including 1 in intensive care. One patient reported worsening chronic urticaria symptoms while infected with COVID-19. Five (18%) patients experienced worsening chronic urticaria symptoms after recovery from COVID-19. All patients recovered from COVID-19 without serious sequelae. Omalizumab did not appear to increase the risk of severe COVID-19 and can be safely used in patients with chronic urticaria.

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Abstract Background: The course of chronic spontaneous urticaria (CSU) can be influenced by infections, depression, and stress. Objectives: Our aim was to investigate the impact of the COVID-19 pandemic on the course of refractory CSU together with patient adherence to omalizumab and treatment adjustments. Methods: Urticaria Activity Score (UAS7) was used to assess disease activity. Fear of COVID-19 Scale (FC-19s), and Depression Anxiety Stress Scale (DASS-21s) were performed to assess mental health status. All scales were performed during the Quarantine Period (QP) and Return to the Normal Period (RTNP). UAS7 Before Pandemic (BP) was recorded from the patients medical records. Results: The authors evaluated 104 omalizumab-receiving CSU patients. UAS7 scores during QP were significantly higher than those in RTNP and BP (p < 0.01). DASS-21 and FC-19 scores were significantly higher during QP compared to RTNP (p < 0.01). Nineteen (18.2%) patients ceased omalizumab, 9 patients prolonged the intervals between subsequent doses during the pandemic. UAS7 scores in QP were significantly higher in patients who ceased omalizumab than in those who continued (p < 0.001). Among patients who continued omalizumab, 22.4% had an increase in urticaria activity and higher FC-19 scores in comparison with those with stable disease activity (p = 0.008). Study limitations: The small sample size of patients with prolonged intervals of omalizumab and the lack of mental health evaluation with the same tools prior to the study. Conclusions: Fear induced by COVID-19 can determine an increase in disease activity. Therefore, patients on omalizumab should continue their treatment and prolonged interval without omalizumab can be considered in patients with good urticaria control.

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Introduction: urticaria has a high impact on the quality of life of patients with this condition. While there are multiple evidence-based guidelines, these tend to be aimed at providing management recommendations for specialists rather than primary care physicians, who are usually the first to care for patients with urticaria. Objective: to develop a consensus document aimed at presenting evidence-based recommendations to help general practitioners, family doctors, pediatricians, internists and emergency physicians provide timely care for patients with urticaria, facilitating its diagnosis and timely care, and thus avoiding delays for the patients. Methods: international urticaria guidelines with recommendations based on the GRADE system were used as the source of information. Delegates of the interested scientific societies were convened, and, through structured meetings, treatment barriers and possible solutions for the application of the recommendations in primary care were identified. Results: the main barriers for primary care physicians in applying the guidelines were identified: confusion in the diagnosis, proper timing of treatment, first-line medications, and management of special situations. Possible consensus solutions were proposed for each identified barrier. Conclusion: this consensus document contains recommendations for the management and treatment of acute and chronic urticaria which help primary care physicians provide timely and effective treatment for patients with this disease. (Acta Med Colomb 2022; 48. DOI:https://doi.org/10.36104/amc.2023.2722).

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BACKGROUND: The course of chronic spontaneous urticaria (CSU) can be influenced by infections, depression, and stress. OBJECTIVE: Our aim was to investigate the impact of the COVID-19 pandemic on the course of refractory CSU together with patient adherence to omalizumab and treatment adjustments. METHODS: Urticaria Activity Score (UAS7) was used to assess disease activity. Fear of COVID-19 Scale (FC-19s), and Depression Anxiety Stress Scale (DASS-21s) were performed to assess mental health status. All scales were performed during the Quarantine Period (QP) and Return to the Normal Period (RTNP). UAS7 Before Pandemic (BP) was recorded from the patients medical records. RESULTS: The authors evaluated 104 omalizumab-receiving CSU patients. UAS7 scores during QP were significantly higher than those in RTNP and BP (p < 0.01). DASS-21 and FC-19 scores were significantly higher during QP compared to RTNP (p < 0.01). Nineteen (18.2%) patients ceased omalizumab, 9 patients prolonged the intervals between subsequent doses during the pandemic. UAS7 scores in QP were significantly higher in patients who ceased omalizumab than in those who continued (p < 0.001). Among patients who continued omalizumab, 22.4% had an increase in urticaria activity and higher FC-19 scores in comparison with those with stable disease activity (p = 0.008). STUDY LIMITATIONS: The small sample size of patients with prolonged intervals of omalizumab and the lack of mental health evaluation with the same tools prior to the study. CONCLUSION: Fear induced by COVID-19 can determine an increase in disease activity. Therefore, patients on omalizumab should continue their treatment and prolonged interval without omalizumab can be considered in patients with good urticaria control.

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Food allergy is a common chronic disorder that affects infants, children, adolescents, and adults. The prevalence of food allergy has increased in recent decades throughout the world, not limited to Western countries. Since there is no treatment, this focuses on avoiding allergens, in addition to educating patients and caregivers in the emergency treatment of acute reactions, for example: application of epinephrine. Studies suggest that accidental reactions occur in about 45% of children with food allergies each year, although most reactions are mild or moderate in severity. Hospital admissions for food anaphylaxis vary from 4 to 20 per 100,000 inhabitants; Deaths are rare, with an estimated incidence of 0.03 to 0.3 per million people with food allergy. Death from food anaphylaxis is rare and appears to have remained stable, possibly due to increases in food allergen labeling, diagnostic services, rates of intramuscular epinephrine prescription, and awareness of food allergies. Omalizumab is a drug approved for several disorders (chronic hives or difficult asthma) and may help reduce symptoms associated with food allergy. The relative importance of alternative technologies, management strategies and policies for food allergy varies from one region to another, due to differences in the epidemiology, education, socioeconomic well-being, and cultural preferences of the population.

La alergia alimentaria es un trastorno crónico frecuente que afecta a lactantes, niños, adolescentes y adultos. La prevalencia de alergia alimentaria se ha incrementado en las últimas décadas en todo el mundo, sin limitarse a los países occidentales. Puesto que no existe ningún tratamiento, éste se centra en evitar los alergenos, además de la educación de pacientes y cuidadores en el tratamiento de urgencia de las reacciones agudas, por ejemplo: aplicación de epinefrina. Los estudios sugieren que las reacciones accidentales ocurren en alrededor del 45% de los niños con alergia alimentaria cada año, aunque la mayor parte de las reacciones son de gravedad leve o moderada. Los ingresos hospitalarios por anafilaxia alimentaria varían de 4 a 20 por cada 100,000 habitantes; las muertes son raras, con una incidencia estimada de 0.03 a 0.3 por cada millón de personas con alergia alimentaria. La muerte por anafilaxia alimentaria es rara y parece haberse mantenido estable, posiblemente por el aumento en el etiquetado de alérgenos alimentarios, los servicios de diagnóstico, las tasas de prescripción de epinefrina intramuscular y la concienciación acerca de alergias alimentarias. Omalizumab es un fármaco aprobado para varias alteraciones (urticaria crónica o asma difícil) y puede ayudar a reducir los síntomas asociados con la alergia alimentaria. La importancia relativa de las tecnologías alternativas, las estrategias de gestión y las políticas para la alergia alimentaria varía de una región a otra, debido a las diferencias en la epidemiología, educación, bienestar socioeconómico y preferencias culturales de la población.

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Despite promising advancements in oral immunotherapy for food allergies, medical implementation faces limitations. Non-specific treatment options based on inhibiting the type 2 inflammatory pathway, including monoclonal antibodies, are under investigation. TNX-901 and omalizumab have demonstrated increased reaction thresholds, reducing adverse events in peanut-allergic patients. Dupilumab, blocking the IL-4 receptor, shows positive results in both food allergies and eosinophilic esophagitis. Antibodies against alarmins and anti-IL-5, such as etokimab and mepolizumab, have proven efficacy in preclinical studies and clinical trials. While further studies are needed to establish their practical clinical use and determine suitability for different types of food allergies, these monoclonal antibodies present a promising horizon for the treatment of such conditions.

A pesar de los avances prometedores en la inmunoterapia oral para alergias alimentarias, su implementación médica enfrenta limitaciones. Se investigan opciones no específicas basadas en la inhibición de la vía inflamatoria tipo 2, incluyendo anticuerpos monoclonales. El TNX-901 y omalizumab han demostrado aumentar los umbrales de reacción, reduciendo eventos adversos en pacientes con alergia al cacahuate. El dupilumab, que bloquea el receptor alfa de IL-4, muestra resultados positivos en alergias alimentarias, así como en la esofagitis eosinofílica. Anticuerpos contra alarminas y anti-IL-5, como etokimab y mepolizumab, han demostrado eficacia en estudios preclínicos y ensayos clínicos. Aunque se necesitan más estudios para establecer su uso clínico práctico y determinar la idoneidad para distintos tipos de alergias alimentarias, estos anticuerpos monoclonales presentan un horizonte prometedor para el tratamiento de dichas condiciones.

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A asma grave é uma doença respiratória crônica que afeta as vias aéreas, provocando inflamação e estreitamento dos brônquios. Esse estreitamento pode dificultar a respiração e causar sintomas como tosse, falta de ar, chiado no peito e aperto no peito. Quando a asma não é controlada adequadamente com medicamentos e outras medidas, ela pode evoluir para um quadro de asma grave. O presente artigo científico consiste em uma revisão literária sobre o tratamento da asma grave com elevados níveis de anticorpos IgE por meio do uso do anticorpo monoclonal Omalizumabe, além de apresentar o relato de caso observacional em um paciente pediátrico atendido em um consultório especializado da cidade de Mineiros no estado de Goiás. Os estudos revisados demonstraram que a terapia com Omalizumabe pode melhorar a função pulmonar, reduzir a necessidade de medicação de resgate e melhorar a qualidade de vida em pacientes com asma grave. No entanto, também foi observado que o benefício do Omalizumabe é mais pronunciado em pacientes com níveis mais elevados de IgE e em pacientes que apresentam sintomas asmáticos frequentes. A revisão literária apresentou evidências consistentes de que o Omalizumabe é uma opção terapêutica eficaz e segura para o tratamento de asma grave com elevados níveis de IgE em pacientes pediátricos. Por fim com objetivo de fornecer informações importantes para médicos e profissionais de saúde sobre o uso do Omalizumabe no tratamento da asma grave em crianças, além de destacar a necessidade de mais pesquisas para avaliar a eficácia e segurança do medicamento em populações maiores e com seguimento mais prolongado.

Severe asthma is a chronic respiratory disease that affects the airways, causing inflammation and narrowing of the bronchi. This narrowing can make breathing difficult and cause symptoms such as coughing, shortness of breath, wheezing, and chest tightness. When asthma is not properly controlled with medication and other measures, it can develop into severe asthma. The present scientific article consists of a literature review on the treatment of severe asthma with high IgE antibody levels by the use of the monoclonal antibody Omalizumab, besides presenting the report of an observational case in a pediatric patient seen at a specialized clinic in the city of Mineiros in the state of Goiás. The studies reviewed showed that Omalizumab therapy can improve lung function, reduce the need for rescue medication, and improve quality of life in patients with severe asthma. However, it was also noted that the benefit of Omalizumab is more pronounced in patients with higher IgE levels and in patients who have frequent asthmatic symptoms. The literature review presented consistent evidence that Omalizumab is an effective and safe therapeutic option for the treatment of severe asthma with high IgE levels in pediatric patients. Finally with aim to provide important information for physicians and health care professionals about the use of Omalizumab in the treatment of severe asthma in children, and to highlight the need for further research to evaluate the efficacy and safety of the drug in larger populations and with longer follow-up.

El asma grave es una enfermedad respiratoria crónica que afecta a las vías respiratorias, causando inflamación y estrechamiento de los bronquios. Este estrechamiento puede dificultar la respiración y causar síntomas como tos, falta de aire, sibilancias y opresión torácica. Cuando el asma no se controla adecuadamente con medicación y otras medidas, puede convertirse en asma grave. El presente artículo científico consiste en una revisión bibliográfica sobre el tratamiento del asma grave con niveles elevados de anticuerpos IgE mediante el uso del anticuerpo monoclonal Omalizumab, además de presentar el informe de un caso observacional en un paciente pediátrico atendido en una clínica especializada de la ciudad de Mineiros, en el estado de Goiás. Los estudios revisados demostraron que el tratamiento con omalizumab puede mejorar la función pulmonar, reducir la necesidad de medicación de rescate y mejorar la calidad de vida en pacientes con asma grave. Sin embargo, también se observó que el beneficio del omalizumab es más pronunciado en pacientes con niveles más altos de IgE y en pacientes que presentan síntomas asmáticos frecuentes. La revisión bibliográfica presentó pruebas consistentes de que omalizumab es una opción terapéutica eficaz y segura para el tratamiento del asma grave con niveles elevados de IgE en pacientes pediátricos. Finalmente con el objetivo de proporcionar información importante para los médicos y profesionales de la salud sobre el uso de Omalizumab en el tratamiento del asma grave en niños, así como destacar la necesidad de nuevas investigaciones para evaluar la eficacia y seguridad del fármaco en poblaciones más grandes y con un seguimiento más prolongado.

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Objective: To compare the costs of dupilumab and omalizumab for treating severe allergic asthma patients from the perspective of the Brazilian private healthcare system. Methods: Using clinical and demographic inputs from the literature, we simulated a cohort of 5,000 severe allergic asthma patients and estimated the treatment cost with omalizumab. Results: In the simulated cohort, 81.3% were female, the mean body weight was 75.1 kg (SD 13.1), and the mean serum IgE was 532 IU/mL (SD 688). All patients were eligible for treatment with dupilumab, but 830 (16.6%) were ineligible for treatment with omalizumab due to serum IgE level and/or body weight combinations, according to the product label. Over four weeks, the mean dose of omalizumab was 537 mg (SD 285). The annual mean per-patient cost for treatment with omalizumab was BRL 110,783.89 (SD 58,385.81), ranging from BRL 31,797.49 to BRL 246,643.15. The treatment cost with dupilumab is BRL 111,724.21 for the first year and BRL 107,599.91 for subsequent years. Conclusions: We observed slightly lower mean treatment costs with dupilumab than with omalizumab. However, while the treatment cost with dupilumab is fixed and predictable, the treatment cost with omalizumab is highly variable, depending on patients' characteristics. Health managers should consider these findings for reimbursement and clinical protocol development decisions.

Objetivo: Comparar os custos de dupilumabe e omalizumabe para o tratamento de pacientes com asma alérgica grave na perspectiva do sistema de saúde privado brasileiro. Métodos: Utilizando parâmetros clínicos e demográficos a partir de dados da literatura, simulamos uma coorte com 5.000 pacientes com asma alérgica grave e estimamos o custo de tratamento com o omalizumabe. Resultados: Na coorte simulada, 81,3% eram do sexo feminino, com peso médio de 75,1 kg (DP 13,1) e IgE sérica de 532 IU/mL (DP 688). Todos os pacientes eram elegíveis para o tratamento com dupilumabe, porém 830 (16,6%) não eram elegíveis para o tratamento com omalizumabe devido a combinações específicas de IgE sérica e/ou peso corporal, de acordo com a bula do produto. Para o período de 4 semanas, a dose média de omalizumabe foi de 537 mg (DP 285). O custo médio anual por paciente do tratamento com omalizumabe foi de R$ 110.783,89 (DP 58.385,81), variando de R$ 31.797,49 a R$ 246.643,15. O custo do tratamento com dupilumabe é de R$ 111.724,21 no primeiro ano e R$ 107.599,91 nos anos seguintes. Conclusões: Foi observado que o custo médio do tratamento com dupilumabe é ligeiramente menor que o custo com omalizumabe. Todavia, enquanto o custo do tratamento com dupilumabe é fixo e previsível, o custo do tratamento com omalizumabe é altamente variável, dependendo de características dos pacientes. Esses achados devem ser considerados pelos gestores de saúde para decisões sobre reembolso e desenvolvimento de protocolos clínicos.

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BACKGROUND: The allergic phenotype is responsible for more than 50% of severe asthma cases. In a stepwise approach, add-on treatments such as anti-IgE are used for severe allergic asthma (SAA). This study was aimed to describe the real-world effectiveness of omalizumab in adult and pediatric patients with SAA in Colombia. METHODS: This was an observational, non-interventional, retrospective study. Data from patients with SAA that received at least one month of treatment with omalizumab was obtained from medical records at eight sites in Colombia. Time-zero (t - 0) was defined as the date of initiation of omalizumab, and data was gathered for a 12-month period before t - 0 and a 12-month period after t - 0. Clinical outcomes, including exacerbations, were assessed at 6 and 12 months. Effectiveness of omalizumab was evaluated in terms of the reduction of the risk of exacerbations (annualized rate). RESULTS: We included 143 patients with SAA. There was a decrease of 72.4% of the annualized rate of clinically significant asthma exacerbations during the year after omalizumab (from 1.74 before to 0.48 after) with a substantial reduction of the risk of exacerbations by 56.7% (RR [95% CI] 0.43 [0.30-0.63] p < 0,001). CONCLUSION: The use of omalizumab in Colombia as a treatment for SAA notably reduced the risk of clinically significant exacerbations. This study is the first to evaluate omalizumab real-life effectiveness in pediatric and adult patients in the country.

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Abstract Background: Chronic Spontaneous Urticaria (CSU) is characterized by recurrent wheals and/or angioedema for longer than 6-weeks. Guidelines recommend Omalizumab (Oma) as first-line and Cyclosporine-A (Cs-A) as second-line treatment in antihistamine resistant CSU. This step-wise algorithm might be time-consuming and costly. Objective: To determine indicators of response to Oma or Cs-A in CSU patients. Methods: We retrospectively analyzed data from seven centers in Turkey; the inclusion criteria for patients were to receive both Oma and Cs-A treatment (not concurrently) at some point in time during their follow-up. Clinical and laboratory features were compared between groups. Results: Among 110 CSU patients; 47 (42.7%) were Oma-responders, 15 (13.6%) were Cs-A-responders, and 24 (21.8%) were both Oma and Cs-A responders and 24 (21.8%) were non-responders to either drug. High CRP levels were more frequent in Cs-A-responders (72.7% vs. 40.3%; p = 0.055). Oma-responders had higher baseline UCT (Urticaria Control Test) scores (6 vs. 4.5; p = 0.045). Responders to both drugs had less angioedema and higher baseline UCT scores compared to other groups (33.3% vs. 62.8%; p = 0.01 and 8 vs. 5; p = 0.017). Non-responders to both drugs had an increased frequency in the female gender and lower baseline UCT scores compared to other groups (87.5% vs. 61.6%; p = 0.017 and 5 vs. 7; p = 0.06). Study Limitations: Retrospective nature, limited number of patients, no control group, the lack of the basophil activation (BAT) or BHRA (basophil histamine release assay) tests. Conclusions: Baseline disease activity assessment, which considers the presence of angioedema and disease activity scores, gender, and CRP levels might be helpful to predict treatment outcomes in CSU patients and to choose the right treatment for each patient. Categorizing patients into particular endotypes could provide treatment optimization and increase treatment success. © 2022 Published by Elsevier España, S.L.U. on behalf of Sociedade Brasileira de Dermatologia. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/).

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BACKGROUND: Chronic Spontaneous Urticaria (CSU) is characterized by recurrent wheals and/or angioedema for longer than 6-weeks. Guidelines recommend Omalizumab (Oma) as first-line and Cyclosporine-A (Cs-A) as second-line treatment in antihistamine resistant CSU. This step-wise algorithm might be time-consuming and costly. OBJECTIVE: To determine indicators of response to Oma or Cs-A in CSU patients. METHODS: We retrospectively analyzed data from seven centers in Turkey; the inclusion criteria for patients were to receive both Oma and Cs-A treatment (not concurrently) at some point in time during their follow-up. Clinical and laboratory features were compared between groups. RESULTS: Among 110 CSU patients; 47 (42.7%) were Oma-responders, 15 (13.6%) were Cs-A-responders, and 24 (21.8%) were both Oma and Cs-A responders and 24 (21.8%) were non-responders to either drug. High CRP levels were more frequent in Cs-A-responders (72.7% vs. 40.3%; p = 0.055). Oma-responders had higher baseline UCT (Urticaria Control Test) scores (6 vs. 4.5; p = 0.045). Responders to both drugs had less angioedema and higher baseline UCT scores compared to other groups (33.3% vs. 62.8%; p = 0.01 and 8 vs. 5; p = 0.017). Non-responders to both drugs had an increased frequency in the female gender and lower baseline UCT scores compared to other groups (87.5% vs. 61.6%; p = 0.017 and 5 vs. 7; p = 0.06). STUDY LIMITATIONS: Retrospective nature, limited number of patients, no control group, the lack of the basophil activation (BAT) or BHRA (basophil histamine release assay) tests. CONCLUSIONS: Baseline disease activity assessment, which considers the presence of angioedema and disease activity scores, gender, and CRP levels might be helpful to predict treatment outcomes in CSU patients and to choose the right treatment for each patient. Categorizing patients into particular endotypes could provide treatment optimization and increase treatment success.

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Background: Although chronic urticaria (CU) is a common, cause of medical consulting both in general practitioners and allergist specialists worldwide, there is little information about its behavior and management in Latin America. Currently, national and international guidelines recommend using Omalizumab for cases refractory to management with antihistamines. Despite advances in the knowledge of Omalizumab for the management of CU, although there are few studies in underdeveloped countries, there are many studies evaluating the impact of Omalizumab treatment. There is not clinical information related with CSU-Omalizumab in patient settled in the Caribbean area. This research aims to evaluate the management of CU with Omalizumab in a real-life scenario in Colombia. Methodology: We conducted an observational, descriptive, and retrospective study with patient recruitment between 2014 and 2017 of individuals diagnosed with Chronic Urticaria (CU) treating allergology specialists in five Colombian cities. We included patients with CU who failed to achieve disease control after treatment for 4 weeks with fourfold doses of second-generation H1-antihistamines, as recommended by the EAACI/GA2LEN/EDF/WAO guidelines and who received treatment with Omalizumab. Results: We included 123 patients, 73.1% (n = 90) were women. The mean age was 47.1 years (Standard Deviation, SD: 16.2). The median of the total months of disease evolution was 30 (IQR = 13-58). 81.3 % (n = 100) of patients were diagnosed with chronic spontaneous urticarial (CSU). 4.8% (n = 6) had inducible CU (CIndU), and 13.8% (n = 17) reported mixed urticaria (spontaneous CU with at least one inducible component). Regarding emotional factors, 34.9% (n = 43) of subjects indicated anxiety symptoms, 34.1% (n = 42) had exacerbations associated with stress, and 14.6% (n = 18) manifested episodes of sadness. The percentage of patients with CSU controlled according to medical criteria at 3 months with Omalizumab were 80% (n = 80/100) and at 6 months 87% (n = 87/100). The frequency of adverse events was 29.2% (n = 36), with headache being the most frequent adverse event. Conclusions: This real-life study with Omalizumab at CU describes percentages of effectiveness and safety similar to those observed in pivotal and real-life studies conducted in other regions around the world.

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The management of severe uncontrolled asthma with biologics is an area of extreme difficulty given the scarcity of information regarding their starting criteria, the variables to be evaluated to determine the efficacy and safety of their management, the cut-off points to determine the timing to change or add another biological and the process to decrease or withdraw steroids. This review incorporates the latest information and makes a proposal based on it.

El manejo del asma grave descontrolada con biológicos es un área de extrema dificultad, dada la escasez de información respecto a los criterios de inicio de los mismos, las variables a evaluar para determinar la eficacia y seguridad de su manejo, los puntos de corte para determinar el momento oportuno para cambiar o agregar otro biológico y el proceso para disminuir o retirar los esteroides. Esta revisión incorpora la información más reciente y realiza una propuesta con base en ella.

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As urticárias são dermatoses frequentes, acometendo 15% a 20% da população, com pelo menos um episódio agudo da doença na vida. São classificadas em agudas (≤ 6 semanas) ou crônicas (> 6 semanas), de etiologia induzida ou espontânea. A urticária crônica espontânea tem prevalência estimada entre 1% e 2% da população mundial. Apresenta intenso comprometimento da qualidade de vida dos doentes, de forma que afeta várias esferas da vida como relacionamentos interpessoais, perdas laborais, interferência no estudo, perda de sono, entre outras, além de provocar transtornos psiquiátricos em 46% dos doentes pela imprevisibilidade das crises e peso monetário pela perda laboral e custo de tratamento contínuo. Atualmente os anti-histamínicos não sedantes (de segunda geração) constituem a pedra angular no tratamento da urticária crônica espontânea, em decorrência dos seus efeitos reduzidos sobre as atividades cognitivas e outras no sistema nervoso central e cardiovascular. A abordagem terapêutica se inicia com as doses licenciadas pelos fabricantes e é consenso internacional que os anti-histamínicos de segunda geração podem ser usados em doses duplicadas, triplicadas ou quadruplicadas, pois as doses padrão controlam apenas 39% dos doentes. Ainda assim, para grupo substancial dos doentes, torna-se necessária a segunda linha de tratamento, que é o omalizumabe, (um anticorpo monoclonal anti-imunoglobulina E [IgE] e anti-receptor de alta afinidade da IgE nos mastócitos e basófilos). Como terceira linha terapêutica, destaca-se a ciclosporina. Em raros casos refratários às medidas anteriores, há drogas com menor nível de evidência científica disponíveis, as quais são abordadas neste artigo de revisão.

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El manejo del asma grave descontrolada con biológicos es un área de extrema dificultad, dada la escasez de información respecto a los criterios de inicio de los mismos, las variables a evaluar para determinar la eficacia y seguridad de su manejo, los puntos de corte para determinar el momento oportuno para cambiar o agregar otro biológico y el proceso para disminuir o retirar los esteroides. Esta revisión incorpora la información más reciente y realiza una propuesta con base en ella.

The management of severe uncontrolled asthma with biologics is an area of extreme difficulty given the scarcity of information regarding their starting criteria, the variables to be evaluated to determine the efficacy and safety of their management, the cut-off points to determine the timing to change or add another biological and the process to decrease or withdraw steroids. This review incorporates the latest information and makes a proposal based on it

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OBJECTIVE: In patients with uncontrolled asthma, despite management with high doses of inhaled corticosteroids, the additional use of omalizumab and tiotropium is recommended. Omalizumab is an expensive medication and doubts arise as to whether the benefit of this drug outweighs the additional expense of the drug. The purpose of this study was to assess the cost-effectiveness of tiotropium versus omalizumab as add-on therapies to ICS + LABA for patients with uncontrolled allergic asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life years (QALYs) of patients with uncontrolled allergic asthma in Colombia. Total costs and QALYs of three interventions including standard therapy (ICS + LABA), add-on therapy with tiotropium, and add-on therapy with omalizumab, were calculated over a 10-year time horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. RESULTS: The model showed that tiotropium was associated with lower cost than standard therapy and omalizumab (US$5590 vs. US$5693 vs. U$18,154 average annual cost per patient), and higher QALYs (11.8 vs. 11.3 vs. 11.9) average per patient), showing dominance respect to standard therapy. The probability that tiotropium provides a more cost-effective use of resources compared with standard therapy exceeds 99% for willingness-to-pay threshold. CONCLUSION: Add-on therapy with tiotropium was a cost-effective alternative to omalizumab and standard therapy for uncontrolled allergic asthma. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

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OBJECTIVE: To describe the medical and laboratory profile of the patients who have been diagnosed with chronic urticaria in the outpatient clinic of a tertiary care hospital of the social security system in Costa Rica. METHODS: All patients over 13 years of age who had been diagnosed with chronic urticaria between January 1st, 2014, and December 31st, 2018 were included. Variables of medical and laboratory data were statistically analyzed, and the treatment of the patients between their first and last medical consultation was compared. RESULTS: This was about 160 patients who had been diagnosed with chronic urticaria; 129 of them were women, 45.7 % between the ages of 30-49 years; in 17.5 % of them (28 patients), inducible urticaria was associated; 54.8 % (46/84) had positive antithyroperoxidase antibodies; 16.9 % (27 patients) maintained a single dose of second-generation anti-H1 antihistamines in the last consultation; 16.3 % (26 patients) no longer required antihistamine treatment in the last consultation. Cyclosporine was used in 8.8 % (14 patients), and omalizumab was used in 2.5 % (four patients). CONCLUSION: Since this is a real-life study in a geographic region with limited publications on this pathology, we trust that the provided information will contribute to the scientific community in order to improve the quality of life of patients with chronic urticaria through a timely diagnosis and an effective and efficient treatment.

Objetivo: Describir el perfil clínico y de laboratorio de los pacientes diagnosticados con urticaria crónica en la consulta externa de alergología en un hospital de tercer nivel de atención del sistema de seguridad social de Costa Rica. Métodos: Se incluyeron todos los pacientes mayores de 13 años diagnosticados con urticaria crónica entre el 1 de enero de 2014 y el 31 de diciembre de 2018. Se analizaron estadísticamente variables de datos clínicos y de laboratorio y se comparó el tratamiento de los pacientes entre la primera y última consulta. Resultados: Se trató de 160 pacientes con diagnóstico de urticaria crónica: 129 del sexo femenino, 45.7 % con edad entre 30 y 49 años, en 17.5 % (28 pacientes) se asoció urticaria inducible, 54.8 % (46/84) presentó anticuerpo antitiroperoxidasa positivo, 16.9 % (27 pacientes) se mantuvo en la última consulta con una dosis de antihistamínicos anti-H1 de segunda generación; 16.3 % (26 pacientes) ya no requería tratamiento antihistamínico en la última consulta. En 8.8 % de los casos (14 pacientes) se utilizó ciclosporina y en 2.5 % (cuatro pacientes), omalizumab. Conclusión: Al tratase de un estudio de vida real en una región geográfica con limitadas publicaciones sobre esta patología, confiamos que la información provista contribuya a la comunidad científica a mejorar la calidad de vida de los pacientes con urticaria crónica mediante un diagnóstico oportuno y un tratamiento eficaz y efectivo.

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