Surya P. Bhatt, MD, MSPH

Credit: uab.edu

Dupilumab may improve lung function, exacerbations, life quality, exacerbations, and symptoms in those with chronic obstructive pulmonary disease (COPD) patients with and Type 2 (T2) inflammation, according to new data presented at the European Respiratory Society (ERS) International Congress 2023 in Milan.¹

The fully-human monoclonal antibody is known to be a newly-realized asset in the treatment of T2 inflammation, as it essentially blocks the shared receptor component in 2 major contributors to such inflammation: interleukin-4 (IL-4) and interleukin-13 (IL-13).

The investigators that identified these new findings noted the central role T2 inflammation maintains in several different types of respiratory diseases, including COPD. As such, these researchers had worked to assess both the safety profile and the efficacy of dupilumab in this patient population.

The new research was led by Surya P. Bhatt, MD, MSPH, from the University of Alabama at Birmingham’s Division of Pulmonary, Allergy and Critical Care Medicine.

Background and Findings

Bhatt and colleagues conducted the BOREAS trial and it took place over the course of 52 total weeks and represented a phase 3 trial. They used a double-blind, placebo-controlled design and set out to assess biweekly doses of dupilumab at 300mg in individuals with COPD that also exhibited blood eosinophils of 300 cells/µL or more during the time of screening.

Participants involved in the team’s research had already been on triple therapy, made up of an inhaled corticosteroid (ICS), long-acting β2-agonists (LABA), and long-acting muscarinic antagonists (LAMA). Alternatively, the investigators could also have been on LABA/LAMA if an ICS was shown to be contraindicated.

The investigators determined their primary endpoint to be focused on the annualized moderate-to-severe exacerbation rate, and their secondary endpoints were set to include the changes found in pre-bronchodilator FEV1 at 12 and 52 weeks, the cumulative exacerbations reported over time, and evaluations in safety.

The investigators ended up enrolling 939 study participants, and these individuals were randomly assigned to be in 1 of 2 groups: either the placebo, which ended up with 471 participants, or the dupilumab group, which had 468.
The research team’s results suggested that the drug was shown to have substantially diminished rates of exacerbation in these patients by about 30% versus the placebo arm (P=0.0005).

Additionally, the team expressed that the drug led to major improvements in participants’ reported lung functioning. They specifically noted a significant rise in pre-bronchodilator FEV1 and this was seen at 12 weeks (LSM difference vs placebo: 83 mL, P<0.0001), with the benefit being sustained through to week 52 (83 mL, P=0.0003).

The investigators also found a trend toward diminished annualized complete duration of patients’ systemic corticosteroid treatment necessary for their exacerbations. The drug was shown to lead to a reduction in systemic corticosteroid days compared to those in the placebo arm.

This trended toward a reduction in the annualized total duration of systemic corticosteroid treatment required for exacerbations, with the drug showing a reduction in systemic corticosteroid days versus those in the placebo arm.

The team also noted a well-balanced safety profile between both those in the treatment arm and those in the placebo arm. They added that the treatment-emergent adverse events were shown to be similar in both of the groups.

The investigators concluded that dupilumab could be useful in the treatment of moderate-to-severe COPD, specifically characterized by T2 inflammation.

References

1. ^{Surya P Bhatt, MD, et al. Efficacy and Safety of Dupilumab for COPD with Type 2 Inflammation Indicated by Elevated Eosinophils. Paper presented at: European Respiratory Society (ERS) International Congress 2023; September 9 – 13. Milan, Italy. Accessed September 14, 2023.}