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

• Published in: Pulmonary pharmacology & therapeutics Vol. 31; pp. 28 - 35
• Main Authors: Caminati, Marco, Senna, Gianenrico, Guerriero, Massimo, Dama, Anna Rita, Chieco-Bianchi, Fulvia, Stefanizzi, Giorgia, Montagni, Marcello, Ridolo, Erminia
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.04.2015
• Subjects: Adult; Anti-Asthmatic Agents - adverse effects; Anti-Asthmatic Agents - therapeutic use; Asthma - complications; Asthma - drug therapy; Comorbidities; Data Collection; Effectiveness; Efficacy; Humans; Medical Education; Omalizumab; Omalizumab - adverse effects; Omalizumab - therapeutic use; Product Surveillance, Postmarketing - statistics & numerical data; Pulmonary/Respiratory; Quality of Life; Randomized Controlled Trials as Topic - statistics & numerical data; Respiratory Function Tests; Safety; Severe allergic asthma; Severity of Illness Index; Omalizumab; Efficacy; Effectiveness; Severe allergic asthma; Safety; Comorbidities
• ISSN: 1094-5539; 1522-9629
• DOI: 10.1016/j.pupt.2015.01.006

Abstract 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.