A fully human monoclonal antibody to Interleukin 4 receptor alpha subunit.
Inhibits signaling of IL-4 and IL-13 two cytokines central to type 2 helper T-cell mediated inflammation.
Tradename Dupixent.
The subcutaneously injected monoclonal antibody has been approved for the maintenance treatment of patients 12 years or older with moderate to severe asthma within the eosinophilic phenotype or with oral corticosteroids dependent asthma.
Among patients with COPD, with type 2 inflammation as indicated by elevated eosinophil counts, who received do dupilumab had fewer exacerbations, better a lung function and quality of life, and less severe respiratory symptoms than those who received placebo.
Has demonstrated clinical efficacy in type 2 helper T-cell mediated diseases of asthma and atopic dermatitis and also improves sinonasal symptoms of patients with asthma.
Among adults with symptomatic chronic sinusitis and nasal polyps refractory to intranasal corticosteroids the addition of subcutaneous dupilumab to nasal steroids reduced endoscopic nasal polyp burden after 16 weeks (Bachert C et al).
Approval of an injection for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or the therapies are not advisable.
A human monoclonal antibody, designed to specifically inhibit overactive signaling of the proteins IL-4 and IL-13, the key proteins driving the underlying inflammation in AD.
Patients treated with dupilumab monotherapy in the SOLO 1 and SOLO 2 studies experience improvement in measures of skin clearing and overall extent and severity of disease.
At 16 weeks, 38% of patients in the SOLO 1 trial and 36% in the SOLO 2 trial who received 300 mg of dupilumab every 2 weeks achieved clear or almost clear skin, compared with 10% and 9% with placebo, respectively.
In the CHRONOS study, patients treated with dupilumab plus topical corticosteroids significantly improved overall disease severity at 16 and 52 weeks, when compared with placebo plus topical corticosteroids.
The CHRONOS study demonstrates that 36% of patients who received 300 mg of dupilumab every 2 weeks with topical corticosteroids achieved clear or almost clear skin, compared with 13% of patients receiving placebo with topical corticosteroids.
Among children with uncontrolled moderate to severe asthma dupilumab had fewer asthmatic exacerbations and better lung function asthma control than those who received placebo.
The most common adverse events: are injection site reactions, eye and eye lid inflammation, including redness, swelling, and itching, and cold sores in the mouth or on the lips.
Comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.
In asthma studies it was administered subcutaneously 300 mg, following a loading dose of 600 mg every two weeks for 24 weeks.
Adverse effects include injection site reactions, transient eosinophilia, eosinophilic pneumonia, vasculitis, and conjunctivitis.
Among patients with eosinophilic esophagitis subcutaneous dupilumab improves histological outcomes and alleviated symptoms of the disease.