Chance for better treatment for COPD

This also includes an increase in lung function. The European Medicines Agency (EMA) has now recommended the approval of a monoclonal antibody for patients with classic smoker’s disease and poor symptom control.

The drug is the monoclonal antibody dupilumab, which has already been approved in more than 60 countries around the world for chronic inflammatory diseases such as atopic dermatitis, asthma, etc. The drug blocks a certain proportion of the receptors for the immune messenger interleukin-4 on white blood cells (B and T cells) and thereby inhibits the inflammatory effect of interleukin-4 and interleukin-13. The drug does not weaken the immune system.

Effect proven in two large studies

The effect on COPD has been proven in two large clinical studies on effectiveness and tolerability. One of these was published just a few weeks ago in the New England Journal of Medicine (DOI: 10.1056/NEJMoa2401304). Around five percent of people suffer from the chronic disease, which is associated with an accelerated decline in lung function. In Austria, it is estimated that 400,000 to 800,000 people are affected. In the vast majority of cases, it is a consequence of smoking. In most of those affected, the disease is only diagnosed at a late stage. Drug treatment is currently based mostly on long-acting drugs to reduce inflammation (cortisone) and to expand the bronchi (beta-agonists, anticholinergics) in the form of sprays for inhalation.

This is by no means always successful. “About half of patients with COPD continue to have sudden deteriorations (exacerbations; note) despite maximum treatment with triple inhalation therapy (…),” wrote the international team of authors, including the German pulmonologist Klaus Rabe (Lungenclinic Großhansdorf near Hamburg) in the New England Journal of Medicine. Dupilumab could be an option for COPD sufferers with a certain inflammatory reaction (type 2; eosinophilia).

Lung function improved

935 patients were included in the study. Half received the monoclonal antibody, the other half a placebo. After one year, the data from 721 subjects could be evaluated. Overall, the COPD patients who had received dupilumab in addition to their other medications had a third fewer acute exacerbations than the placebo group, which often involve hospital admission and ventilation. Such exacerbations often lead to a permanent deterioration in lung function. In contrast, the lung function of those treated with dupilumab in the study improved significantly.

“Dupilumab is the first new treatment approach for COPD in more than a decade. In the EU, this means a new treatment option for around 220,000 adults with the disease,” said a press release from the pharmaceutical company Sanofi.

In the USA, the drug is still being reviewed by the US Food and Drug Administration (FDA). A decision is expected next September. However, a few days ago, another new COPD drug was approved for inhalation. It is the active ingredient ensifentrin, which, as an inhibitor of two enzymes (PDE3 and PDE4), is intended to both expand the bronchi and reduce inflammation in chronic obstructive pulmonary disease. In clinical studies, this therapy has been shown to reduce the frequency of exacerbations by 40 percent and improve lung function.