• Marco Caminati, Gianenrico Senna, Massimo Guerriero, Anna Rita Dama, Fulvia Chieco-Bianchi, Giorgia Stefanizzi, Marcello Montagni, and Erminia Ridolo.
• Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: ma.caminati@gmail.com.
• Pulm Pharmacol Ther. 2015 Apr 1; 31: 28-35.

AbstractRandomized 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. Copyright © 2015 Elsevier Ltd. All rights reserved.

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