RESUMEN
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.
Asunto(s)
Antiasmáticos , Asma , Hipersensibilidad , Humanos , Omalizumab/uso terapéutico , Antiasmáticos/uso terapéutico , Estudios Retrospectivos , Colombia , Resultado del Tratamiento , Asma/tratamiento farmacológicoRESUMEN
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)