Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL), that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reaction, and rhinosinusitis. Dupilumab was generated by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.
Dupilumab is commonly marketed as Dupixent, which is available as a formulation for subcutaneous injection. It was first approved by the FDA in 2017. It is currently used to treat atopic dermatitis, asthma as an add-on maintenance treatment, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. It is used as monotherapy or in combination with other drugs, such as corticosteroids. Dupilumab is currently under investigations for potential therapeutic use in diseases driven by allergic reactions or type 2 inflammation, such as pediatric atopic dermatitis, and chronic obstructive pulmonary disease. It is also being studied in combination with another antibody that which targets IL-33.
In the US, dupilumab is indicated for the treatment of patients aged six months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In Europe and Canada, the drug for this indication is approved for patients aged six years and older. In Europe, patients six to 11 years of age should have severe atopic dermatitis and be candidates for systemic therapy. Dupilumab can be used with or without topical corticosteroids for this condition.
Dupilumab is indicated as an add-on maintenance treatment of patients aged six years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. However, the drug is not indicated for relief of acute bronchospasm or status asthmaticus.
Dupilumab is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis. In Canada and Europe, it is used with intranasal corticosteroids.
In the US and Europe, dupilumab is also indicated for the treatment of adults and children aged 12 years and older weighing at least 40 kg with eosinophilic esophagitis (EoE), and adults with prurigo nodularis.
Regeneron Study Site, Lubin, Dolnoslaskie, Poland
IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG., Frankfurt am Main, Hessen, Germany
IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz, Mainz, Rheinland-Pfalz, Germany
Regeneron Research Site, La Jolla, California, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University, Palo Alto, California, United States
Mayo Clinic, Scottsdale, Arizona, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Investigational Site Number :3800001, Pisa, Italy
Investigational Site Number :7240003, Manises, Valencia, Spain
Investigational Site Number :3800002, Roma, Italy
Bichat-Claude Bernard University Hospital, Paris, France
Service d'Allergologie et Immunologie Clinique - Hôpital Lyon Sud, Pierre-Bénite, France
Regeneron Research Site, Boston, Massachusetts, United States
Brigham and Women's Hospital, Department of Dermatology, Boston, Massachusetts, United States
Investigational Site Number 1560006, Changsha, China
Investigational Site Number 1560030, Lianyungang, China
Investigational Site Number 1560021, Changchun, China
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
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