The U.S. Food and Drug Administration has approved Dupilumab as an add-on maintenance therapy in patients with moderate-to-severe asthma, announced Regeneron Pharmaceuticals, and Sanofi. In a trial, it has been found that more than half of patients treated with Dupilumab completely eliminated the use of oral corticosteroids.
It comes in a pre-filled syringe and is intended for subcutaneous injection under the guidance of a healthcare provider. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional.
Dupilumab has been already approved to treat moderate-to-severe atopic dermatitis and now is a part of asthma treatments that are given by injection rather than inhaled, and acts on an underlying cause of asthma rather than treating the symptoms. The drug can be safely used in patients aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
- Dupilumab is only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype.
- It is only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype.
- It is only asthma biologic that offers patient self-administration at home
- It is only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway.
Dupilumab inhibits the overactive signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).
“Despite being compliant with their current medicine, many people with moderate-to-severe asthma, including those with the eosinophilic phenotype or with oral steroid dependence, live with persistent symptoms like unpredictable attacks and difficulty breathing,” said Kenneth Mendez, president, and CEO of the Asthma and Allergy Foundation of America (AAFA). “AAFA supports the availability of innovative new treatment options for people with asthma who struggle with uncontrolled symptoms that impair their quality of life.”
The drug bagged the approval after the pivotal trial program which evaluated 2,888 adult and adolescent patients with moderate-to-severe asthma in three randomized, placebo-controlled, multicenter trials (Trial 1, Trial 2 and Trial 3) for six months to one year (24 to 52 weeks). All trials enrolled patients irrespective of minimum baseline eosinophil levels.
The Trial 2 report shows that:
- In Trial 2 (the largest trial), Dupilumab reduced exacerbations and improved lung function in the overall population.
- Benefits in exacerbations were seen in patients with eosinophil counts greater than or equal to 150 cells/microliter, which represented 70% of the patients enrolled.
- Efficacy improved in patients with higher eosinophil counts. For example, in patients with blood eosinophils of 300 cells/microliter or greater, Dupixent reduced severe exacerbations by 67% compared to placebo and improved FEV1(lung function) by 29%-33% compared to 14%-16% for placebo.
- In patients with eosinophil counts less than 150 cells/microliter, there was no difference in severe exacerbation rates for Dupixent versus placebo.
The trial 3 report shows that:
- In Trial 3, which evaluated severe, oral corticosteroid-dependent patients, Dupilumab reduced average daily oral corticosteroid use by 70% compared to 42% with placebo.
- More than half of patients treated with Dupixent completely eliminated the use of oral corticosteroids.
- Effects on lung function and on oral steroid and exacerbation reduction were similar for Dupixent irrespective of baseline blood eosinophil levels.
- In the asthma clinical trials, the adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood.
Data from Trial 1 were published in The Lancet in April 2016.
The most common side effects include injection site reaction, pain in the throat (oropharyngeal pain) and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients who have atopic dermatitis.