학술논문
Real-world effectiveness of omalizumab for severe allergic asthma treatment in Colombia
Document Type
Report
Author
Torres-Duque, Carlos A.; Ocampo-Gómez, Jaime; Castillo, Mauricio Morales; Cano-Rosales, Diana; Giraldo-Montoya, Ãngela; Rodríguez, Freddy; Palacios-Ortega, Isabel; Durán-Silva, Mauricio; Reynales, Humberto; García, Elizabeth; Proaéos-Jurado, Juliana; Carreéo, Alejandro; Celis, Ana M.; Chapman, Edgardo; García, Maria B.; González-García, Mauricio; Jiménez-Maldonado, Libardo; Londoéo, Julian; Morales, Edison; Morales-Castillo, Mauricio; Valencia, Viviana; Vanegas, Ingrid; Vargas-Ramírez, Leslie
Source
BMC Pulmonary Medicine. November 28, 2022, Vol. 22 Issue 1
Subject
Language
English
ISSN
1471-2466
Abstract
Author(s): Carlos A. Torres-Duque[sup.1,2] , Jaime Ocampo-Gómez[sup.3] , Mauricio Morales Castillo[sup.4] , Diana Cano-Rosales[sup.5] , Ãngela Giraldo-Montoya[sup.6] , Freddy Rodríguez[sup.7] , Isabel Palacios-Ortega[sup.8] , Mauricio Durán-Silva[sup.1] , Humberto Reynales[sup.9] , [...]
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. Keywords: Effectiveness, Exacerbations, Omalizumab, Severe allergic asthma, Real world
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. Keywords: Effectiveness, Exacerbations, Omalizumab, Severe allergic asthma, Real world