title: Omalizumab for severe allergic asthma in clinical trials and real-life studies: what we know and what we should address.
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.
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: ma.caminati@gmail.com.
authors: Marco
authors: M
authors: Caminati
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: gianenrico.senna@ospedaleuniverona.it.
authors: Gianenrico
authors: G
authors: Senna
authors: Department of Computer Science, University of Verona, Verona, Italy. Electronic address: massimo.guerriero@univr.it.
authors: Massimo
authors: M
authors: Guerriero
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: annarita.dama@ospedaleuniverona.it.
authors: Anna Rita
authors: AR
authors: Dama
authors: Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. Electronic address: fulvia.chiecobianchi@gmail.com.
authors: Fulvia
authors: F
authors: Chieco-Bianchi
authors: Allergy Unit, Verona University and General Hospital, Verona, Italy. Electronic address: giorgia.stefanizzi@libero.it.
authors: Giorgia
authors: G
authors: Stefanizzi
authors: University of Parma, Department of Clinical and Experimental Medicine, Parma, Italy. Electronic address: marcello.m1@hotmail.it.
authors: Marcello
authors: M
authors: Montagni
authors: University of Parma, Department of Clinical and Experimental Medicine, Parma, Italy. Electronic address: erminia.ridolo@unipr.it.
authors: Erminia
authors: E
authors: Ridolo
mesh_terms: D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D003625:Data Collection; D006801:Humans; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index
chemical_list: D018927:Anti-Asthmatic Agents; D000069444:Omalizumab
keywords: Comorbidities; Effectiveness; Efficacy; Omalizumab; Safety; Severe allergic asthma