Introduction

Dupilumab (trade name: Dupixent) has been approved in Germany since May 2019 for the treatment of severe asthma in adults and children aged 12 and over. It is an additional treatment option if treatment with inhaled steroids and at least one other asthma medication no longer manages the symptoms effectively enough.

The airways of people with asthma are constantly inflamed due to an exaggerated response of the body’s immune system. When the mucous membranes of the bronchi come into contact with certain irritants, the airways may contract and become narrow. Symptoms include wheezing, coughing and shortness of breath, which can be treated with various medications.

Dupilumab can be used in people who have a type 2 asthma inflammation. In this very common form of asthma, the air that is breathed out contains too much nitric oxide and/or too many eosinophilic granulocytes. Eosinophilic granulocytes are cells of the body's immune system. In eosinophilic asthma, patients have an increased number of these cells in their blood and phlegm (the mucus they cough up). Nitric oxide forms if the inflammation of the airways is caused by an allergy. Doctors can measure it in the air you breathe out. A high level of nitric oxide is a sign of increased inflammation.

Dupilumab is an antibody to two chemical messengers of the immune system and is supposed to prevent inflammations in the bronchi.

Application

Dupilumab is available in ready-to-use syringes at a dose of 200 or 300 mg.

The first time dupilumab is used, a total of either 400 or 600 mg of the drug (depending on other asthma medication being used) is injected under the skin using two injections. After that, one 200 or 300 mg injection is used every two weeks. Patients can also inject themselves after being instructed how to do so by a doctor.

The effectiveness of the treatment should be checked at least once a year. If the symptoms don’t improve, doctors usually recommend stopping the treatment.

Other treatments

The patients receive individually tailored treatment based on the type and severity of their asthma. If the treatment isn't effective enough, the dose can be increased or several medications can be combined. Depending on your age, the medications that can be combined include corticosteroids (steroids), long-acting bronchodilators, omalizumab, mepolizumab and reslizumab.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of dupilumab when compared with the standard individually tailored treatments for severe asthma in adults and teenagers.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of dupilumab (Dupixent).