TY - JOUR
T1 - Dupilumab for the treatment of asthma
AU - Santini, G
AU - Mores, Nadia
AU - Malerba, M
AU - Mondino, C
AU - Anzivino, R
AU - Macis, G
AU - Montuschi, Paolo
PY - 2017
Y1 - 2017
N2 - Introduction Dupilumab (REGN668/SAR231893), produced by a collaboration between Regeneron and Sanofi, is a monoclonal antibody currently in phase III for moderate-to-severe asthma. Dupilumab is directed against the α-subunit of the interleukin (IL)-4 receptor and blocks the IL-4 and IL-13 signal transduction. Areas Covered Pathophysiological role of IL-4 and IL-13 in asthma; mechanism of action of dupilumab; pharmacology of IL-4 receptor; phase I and phase II studies with dupilumab; regulatory affair. Expert opinion Patients with severe asthma who are not sufficiently controlled with standard-of-care represent the target asthma population for dupilumab. If confirmed, efficacy of dupilumab in both eosinophilic and non-eosinophilic severe asthma phenotype might represent an advantage over approved biologics for asthma, including omalizumab, mepolizumab, and reslizumab. Head-to-head studies to compare dupilumab versus other biologics with different mechanism of action are required. Pediatric studies with dupilumab are currently lacking and should be undertaken to assess efficacy and safety of this drug in children with severe asthma. The lack of preclinical data and published results of the completed four phase I studies precludes a complete assessment of the pharmacological profile of dupilumab. Dupilumab seems to be generally well tolerated, but large studies are required to establish its long-term safety and tolerability.
AB - Introduction Dupilumab (REGN668/SAR231893), produced by a collaboration between Regeneron and Sanofi, is a monoclonal antibody currently in phase III for moderate-to-severe asthma. Dupilumab is directed against the α-subunit of the interleukin (IL)-4 receptor and blocks the IL-4 and IL-13 signal transduction. Areas Covered Pathophysiological role of IL-4 and IL-13 in asthma; mechanism of action of dupilumab; pharmacology of IL-4 receptor; phase I and phase II studies with dupilumab; regulatory affair. Expert opinion Patients with severe asthma who are not sufficiently controlled with standard-of-care represent the target asthma population for dupilumab. If confirmed, efficacy of dupilumab in both eosinophilic and non-eosinophilic severe asthma phenotype might represent an advantage over approved biologics for asthma, including omalizumab, mepolizumab, and reslizumab. Head-to-head studies to compare dupilumab versus other biologics with different mechanism of action are required. Pediatric studies with dupilumab are currently lacking and should be undertaken to assess efficacy and safety of this drug in children with severe asthma. The lack of preclinical data and published results of the completed four phase I studies precludes a complete assessment of the pharmacological profile of dupilumab. Dupilumab seems to be generally well tolerated, but large studies are required to establish its long-term safety and tolerability.
KW - Th2 airway inflammation
KW - asthma
KW - dupilumab
KW - human monoclonal antibodies
KW - interleukin (IL)-13
KW - interleukin (IL)-4
KW - interleukin (IL)-4 receptor
KW - Th2 airway inflammation
KW - asthma
KW - dupilumab
KW - human monoclonal antibodies
KW - interleukin (IL)-13
KW - interleukin (IL)-4
KW - interleukin (IL)-4 receptor
UR - https://publicatt.unicatt.it/handle/10807/91749
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85011933747&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85011933747&origin=inward
U2 - 10.1080/13543784.2017.1282458
DO - 10.1080/13543784.2017.1282458
M3 - Article
SN - 1354-3784
SP - N/A-N/A/A
JO - Expert Opinion on Investigational Drugs
JF - Expert Opinion on Investigational Drugs
IS - N/A
ER -