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.

Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address / Caminati, Marco; Senna, Gianenrico; Guerriero, Massimo; Dama, Anna Rita; Chieco Bianchi, Fulvia; Stefanizzi, Giorgia; Montagni, Marcello; Ridolo, Erminia. - In: PULMONARY PHARMACOLOGY & THERAPEUTICS. - ISSN 1094-5539. - 31:(2015), pp. 28-35. [10.1016/j.pupt.2015.01.006]

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

RIDOLO, Erminia
2015

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.
Omalizumab for severe allergic asthma in clinical trials and real-life studies: What we know and what we should address / Caminati, Marco; Senna, Gianenrico; Guerriero, Massimo; Dama, Anna Rita; Chieco Bianchi, Fulvia; Stefanizzi, Giorgia; Montagni, Marcello; Ridolo, Erminia. - In: PULMONARY PHARMACOLOGY & THERAPEUTICS. - ISSN 1094-5539. - 31:(2015), pp. 28-35. [10.1016/j.pupt.2015.01.006]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2786404
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