Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address

Publication date: Available online 30 January 2015 Source:Pulmonary Pharmacology & Therapeutics Author(s): Marco Caminati , Gianenrico Senna , Massimo Guerriero , Anna Rita Dama , Fulvia Chieco-Bianchi , Giorgia Stefanizzi , Marcello Montagni , Erminia Ridolo Randomized clinical trials (RCTs) are the gold standard for the assessment of any therapeutic intervention. Real-life (R-L) studies are needed to verify the provided results beyond the experimental setting. This review aims at comparing RCTs and R-L studies on omalizumab in adult severe allergic asthma, in order to highlight the concurring results and the discordant/missing data. The results of a selective literature research, including “omalizumab, controlled studies, randomized trial, real-life studies” as key words are discussed. Though some similarities between RCTs and R-L studies strengthen omalizumab efficacy and safety outcomes, significant differences concerning study population features, follow-up duration, local adverse events and drop-out rate for treatment inefficacy emerge between the two study categories. Furthermore the comparative analysis between RCTs and R-L studies highlights the need for further research, concerning in particular long-term effects of omalizumab and its impact on asthma comorbidities.
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research