The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adult patients with chronic obstructive pulmonary disease (COPD). Dupixent is the first biologic therapy to receive approval for COPD in the United States. This approval offers a new approach for managing patients whose disease remains inadequately controlled despite existing treatments.
Clinical Trial Evidence
The approval of Dupixent for COPD was supported by data from two Phase 3 clinical trials, BOREAS and NOTUS. These studies enrolled adult patients with inadequately controlled COPD and evidence of Type 2 inflammation. Participants were already receiving standard inhaled therapies, with many on triple therapy.
The primary objective was to evaluate Dupixent’s ability to reduce moderate or severe acute COPD exacerbations compared to a placebo. In the NOTUS trial, patients receiving Dupixent experienced a 34% reduction in these exacerbations over 52 weeks. A pooled analysis of both studies showed an overall 31% reduction.
Dupixent also showed improvements in lung function. Patients treated with Dupixent exhibited an increase in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at both 12 and 52 weeks. Improvements in health-related quality of life were also observed.
Targeting Underlying Inflammation
A specific subset of COPD patients experiences underlying Type 2 inflammation, which contributes to their disease. This inflammation can cause airways to constrict and narrow, making breathing more difficult.
Dupixent is a monoclonal antibody designed to address this underlying inflammation. It functions by blocking the signaling pathways of two specific proteins, interleukin-4 (IL-4) and interleukin-13 (IL-13). These proteins are drivers of Type 2 inflammation in COPD.
By inhibiting the actions of IL-4 and IL-13, Dupixent aims to calm this specific inflammatory response in the lungs. This mechanism differentiates Dupixent from traditional COPD inhalers, which primarily work by relaxing airway muscles or broadly reducing inflammation.
Identifying Eligible Patients
Dupixent is approved as an add-on maintenance treatment for adults with uncontrolled COPD. It is intended for patients whose symptoms are not adequately managed by their current medications. It is not meant for immediate relief of sudden breathing problems or as a replacement for inhaled rescue medicines.
Patient eligibility requires evidence of Type 2 inflammation, identified through elevated blood eosinophils. Clinical guidelines specify that Dupixent is indicated for COPD patients with a blood eosinophil count of 300 cells/μL or higher. This threshold helps identify individuals who are most likely to benefit from this particular biologic therapy.
The requirement for elevated eosinophils underscores that Dupixent is not a treatment for all COPD patients. Instead, it is a targeted option for a specific group whose disease is driven by this particular inflammatory pathway. Before starting treatment, a complete blood count with differential is performed to confirm the eosinophil level.