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OBJECTIVE To evaluate the cost-effectiveness of omalizumab in the treatment of severe allergic asthma from the perspective of healthcare providers in China. METHODS Based on the data from an international multicenter study of omalizumab in the treatment of severe allergic asthma， the Markov model was constructed according to the progression of severe allergic asthma， with a cycle of 4 weeks. Long-term health outcomes and costs of omalizumab combined with standard of care（SoC） regimen versus SoC regimen in the treatment of severe allergic asthma were simulated by using quality-adjusted life years （QALYs） and incremental cost-effectiveness ratio（ICER） as output indexes. One-way sensitivity analysis， probabilistic sensitivity analysis， and scenario analysis were performed to test the robustness of the results. RESULTS Compared with the SoC regimen， ICER for the omalizumab combined with SoC regimen was 107 723.05 yuan/QALY， which was less than the willingness-to-pay（WTP） threshold （268 074 yuan/QALY） calculated by three times per capita gross domestic product（GDP） in China in 2023. The one-way sensitivity analysis showed that the baseline serum level of immunoglobulin E had the greatest impact on the robustness of the model. The probabilistic sensitivity analysis showed that the omalizumab+SoC regimen had a 93.00% probability of being cost- effective. The scenario analysis showed that in the real world， the billing method of omalizumab based on specifications rather than actual usage may increase ICER. CONCLUSIONS Compared with the SoC regimen， the combination of omalizumab and SoC regimen for treating severe allergic asthma is cost-effective， with a WTP threshold of three times China’s per capita GDP
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Allergen immunotherapy(AIT)is considered the treatment capable of modifying the natural history of allergic respiratory disorders.The adverse reactions associated with AIT limit its clinical use in moderate to severe allergic asthma.Omalizumab is currently approved for the treatment of allergic asthma, chronic spontaneous urticaria, allergic rhinitis and other allergic diseases.A few trials have demonstrated the clinical efficacy of AIT and omalizumab combination therapy in children with moderate to severe allergic asthma.This review summarizes the research progress, mechanisma and application of omalizumab combined with AIT in children with moderate to severe allergic asthma.
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Introdução: a asma é uma doença heterogênea, caracterizada por inflamação crônica das vias aéreas inferiores, associada a diferentes fenótipos. O omalizumabe é utilizado em adição ao tratamento quando não se obtém o controle adequado da asma. Este estudo mostra o perfil epidemiológico e a adesão ao tratamento dos pacientes acompanhados no Ambulatório de Especialidades do Hospital Universitário da Universidade Estadual de Londrina (AEHU-UEL) em uso de omalizumabe em um período de 12 meses. Método: realizado um estudo transversal retrospectivo através de dados secundários de prontuário avaliando pacientes com diagnóstico de asma alérgica grave em uso de omalizumabe nos 12 meses prévios ao recrutamento. Resultados: foram selecionados 40 pacientes que preencheram os critérios de inclusão. A média de idade foi de 51,4 anos, com predomínio de mulheres (70%), brancos (48%), não tabagistas (90%), com sobrepeso ou obesidade (75%) e diagnóstico de asma na infância (45%). O tempo médio de tratamento foi de 8,1 anos (DP 0,8). Havia comorbidades em 85% dos pacientes, com predomínio de rinite (62,5%) e DRGE (40%). Houve exacerbação em 29 pacientes levando a 8 internações (27,5%); 93% dos exacerbadores apresentaram faltas. Conclusão: a amostra é comparável a outros estudos de vida real nos achados epidemiológicos (idade, sexo, fenótipo, tempo de diagnóstico, controle da doença e tabagismo). O elevado número de faltas, assim como frequência de DRGE e outras comorbidades e a baixa adesão à terapêutica, podem justificar o elevado número de exacerbações e maior dificuldade de controle.(AU)
Introduction: asthma is a hetereogeneous disease, characterized by chronic inflammation of the lower airways associated with different phenotypes. Omalizumab is used in addition to treatment when adequate asthma control is not achieved. This study shows the epidemiological profile and the adherence to the treatment of patients followed at the Medical Clinic of the State University Hospital of Londrina (AEHU-UEL) using omalizumab in the last 12 months. Methods: severe allergic asthma patients using omalizumab in the last 12 months were evaluated by means of secondary medical records. Results: forty patients were included and had complete medical record. The average age was 51.4 years mostly women (70%), white (48%), non-smoker (90%), overweight or obese (75%) and childhood asthma diagnosis (45%). The average treatment time was 8.1 years (SD0.8). There were co-morbidities in 85% of the patients, mainly rhinitis in 62.5% and GERD in 40%. There were exacerbations in 29 patients, leading to 8 hospitalizations (27.5%), 93% of exacerbators was missed at least one time. Strong association with rhinitis (p=0.07), and no disease control (p=0.22). Conclusion: the sample is comparable to other real-life studies in almost all epidemiological findings (age, sex, phenotype, time of diagnosis, disease control and smoking). The high number of absences and frequency of GERD and other comorbidities, and poor adhesion, may justify the high number of exacerbations and more difficulty to control the disease. (AU)
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Humans , Asthma , Disease , Omalizumab , Phenotype , Association , Diagnosis , Hospitalization , InflammationABSTRACT
Introduction: Immunoglobulin E dependent mechanisms play an important role in the development of airway inflammation in allergic asthma. Atopic patients with severe asthma frequently have poorly controlled disease. Many have poor asthma control despite intensive treatment. Severe allergic asthma patients frequently treated with oral corticosteroids and therefore may develop serious side-effects. Anti-IgE antibody had been used in severe persistent allergic asthma in Western countries. However, its long-term efficacy in patients in India has not been reported. Objective: To assess the efficacy of anti IgE therapy in patients with severe allergic asthma. Method: 30 (16 male and 14 female) patients, with mean age of 49 having severe persistent allergic asthma, with recurrent exacerbations and on oral/IV steroids, received Omalizumab 150mg/300mg/450 mg for 1 year. Total dose of oral Steroids, use of rescue medications, changes in lung function (FEV1) were recorded at the baseline, 16 weeks & at end of the treatment (52 weeks) and then analyzed. Results: Significant reduction observed in total oral steroid use at 16 week & at 52 weeks. -10.5mg (p<0.003) & 22.5mg respectively. Use of rescue medications decreased by -7.90 puffs(p- <0.001) at 16 weeks and by -13.67 puffs (13.67 (p -<0.001) at 52 weeks. Improvements in lung Function (FEV1) observed with a tune of 700 ml. from Baseline after 52 weeks therapy. Conclusion: Use of anti-IgE antibody for 1 year is well tolerated and led to an overall significant improvement in patients with severe persistent allergic asthma.