FDA Approval of Mepolizumab Offers New Hope for Patients With Eosinophilic COPD: Gerard Criner, MD, FACP, FACCP

Earlier today, the FDA approved mepolizumab (Nucala; GSK) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval was supported in part by findings from the phase 3 MATINEE trial (NCT04133909).

In an interview with The American Journal of Managed Care^®, Gerard Criner, MD, FACP, FACCP, MATINEE investigator and chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University, summarizes the key trial findings. He also discusses how the recent approval of mepolizumab may improve outcomes for patients with COPD and an eosinophilic phenotype.

This transcript was lightly edited for clarity; captions were auto-generated.

Transcript

Can you summarize the key findings of the MATINEE trial and how they support the FDA's review of mepolizumab for patients with COPD and an eosinophilic phenotype?

MATINEE was a phase 3 prospective, randomized, controlled, multicenter, multinational trial, looking at mepolizumab added to optimal care in patients with COPD that had type 2 inflammation, indicated by blood eosinophil counts greater than 300 who had a background history in the past year of at least 1 serious or severe exacerbation or required hospitalization, or at least 2 moderate that needed systemic steroids to treat them.

It basically showed, at the end of 1 year, it was extended to 2 years, to 104 weeks, because of the COVID pandemic. That decreased the ability to measure any serious or frequent moderate exacerbations because of COVID that it was extended to 104 weeks. That makes it the longest trial to look at patients who receive biologic therapy.

At the end of those 104 weeks, it showed that it decreased, in addition to the standard of care, the annualized rate of moderate to severe exacerbations by 21%, and it delayed the onset of the first moderate to severe exacerbation by 98 days, compared with the standard of care. It also, in a nominal way, it decreased ED [emergency department] and hospitalization rates by 35% with mepolizumab compared with the standard of care.

The patient group was sick. They had ranged from moderate to very severe airflow obstruction. About 60% of them had severe and very severe airflow obstruction. They were highly symptomatic in terms of the indices that we use for how sick patients are in terms of COPD care, and their quality of life was impaired by their COPD. Some of them had chronic bronchitis, about 60%, and 40% did not.

It took a wider range of sick patients with COPD and showed that it could decrease moderate and severe exacerbations, which is important for us, because it shows that it decreases hospitalizations and ED visits of patients with COPD, something that really hasn't been shown before.

Now that mepolizumab has received FDA approval, how might it impact outcomes for this population?

If it can decrease the onset of exacerbations in a patient population that has moderate to very severe disease, that's a significant improvement for the standard of care options that patients currently have.

Those exacerbations, flare-ups of a disease, they're trajectory-changing in terms of worsening quality of life, worsening lung function over time, increasing their morbidity, increasing your mortality, increasing the likelihood that they have a cardiac event.

Decreasing the rate by 21% in this type of population, in addition to the standard of care, with really no outstanding side effects, is a great path forward for patients with COPD.