Omalizumab for severe allergic asthma in clinical trials and real-life studies: what we know and what we should address.
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.
['Caminati|Marco|M|', 'Senna|Gianenrico|G|', 'Guerriero|Massimo|M|', 'Dama|Anna Rita|AR|', 'Chieco-Bianchi|Fulvia|F|', 'Stefanizzi|Giorgia|G|', 'Montagni|Marcello|M|', 'Ridolo|Erminia|E|']
D000328:Adult D018927:Anti-Asthmatic Agents D001249:Asthma D003625:Data Collection D006801:Humans D000069444:Omalizumab D011358:Product Surveillance, Postmarketing D011788:Quality of Life D016032:Randomized Controlled Trials as Topic D012129:Respiratory Function Tests D012720:Severity of Illness Index
Omalizumab Severe allergic asthma Efficacy Safety Effectiveness Comorbidities