Dupixent Reduces Systemic Corticosteroid Use in COPD

Patients with chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation had a shorter duration of systemic corticosteroid days when they used Dupixent (dupilumab) to treat acute exacerbations.

The results of the phase 3 BOREAS study were presented at the European Respiratory Society annual meeting, held September 4-6 in Barcelona, Spain. BOREAS was a randomized, double-blind, placebo-controlled trial.

Type 2 inflammation is associated with a greater risk of exacerbations in chronic obstructive pulmonary disease.

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Dupixent is a fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-3, which are the key and central drivers of type 2 inflammation. The agent is already approved to treat moderate-to-severe atopic dermatitis in adults and pediatric patients 6 months and older; moderate-to-severe asthma as an add-on maintenance treatment for adult and pediatric patients 6 months and older; chronic rhinosinusitis with nasal polyps as an add-on maintenance treatment in adults; eosinophilic esophagitis for adult and pediatric patients aged 12 years and older; and prurigo nodularis in adult patients.

Up to 40% of patients with COPD have type 2 inflammation, which is associated with a greater risk of exacerbations. COPD exacerbations increase the risk of additional exacerbations and are associated with lung function decline and high mortality and morbidity.

In BOREAS, the safety and efficacy of Dupixent was evaluated in patients with moderate to severe COPD who also had type 2 inflammation as defined as a baseline blood eosinophil count of ≥ 300 cells/µL.

Patients between the ages of 40 and 80 years (mean age 65 years) were randomized 1:1 to subcutaneous Dupixent (n = 468) or placebo (n = 471) once every 2 weeks for a total of 52 weeks. The majority of patients were White (84%), male (66%), former smokers (70%).

Patients on Dupixent had a reduction in exacerbation rates of 30% compared with placebo. The annualized rate of exacerbations was 1.10 for the placebo compared versus 0.78 for the Dupixent group.

At week 12, Dupixent had significantly increased pre-bronchodilator forced expiratory volume in 1 second (FEV1), post- bronchodilator FEV1, pre-bronchodilator forced vital capacity, and pre-bronchodilator forced expiratory flow compared with placebo, which was sustained through week 52.

As a result, patients on Dupixent had a reduced exacerbation-associated annualized systemic corticosteroid treatment duration (13.57 days for Dupixent versus 19.09 days for placebo).

Patients on Dupixent also had improved patient-reported outcomes compared with patients on placebo. The Dupixent group had improved scores on the St. George’s Respiratory Questionnaire and the Evaluation Respiratory Symptoms in COPD. Patients started reporting improvements in these scores as early as week 4 and they were sustained through week 52.

Safety was similar between the groups with 15.5% of patients on placebo and 13.6% of patients on Dupixent reporting any treatment-emergent serious adverse event (TEAE). The most common TEAEs, occurring in more than 5% of the overall safety population, were nasopharyngitis, headache, upper respiratory tract infection, COPD, diarrhea, back pain, COVID-19, and hypertension.

In the Dupixent group, nasopharyngitis was the most common TEAE (9.4%). The most common TEAE in the placebo group was upper respiratory tract infection (9.8%)

TEAEs led to death in 8 patients on placebo and 7 patients on Dupixent. Overall, 16 patients on placebo and 14 patients on Dupixent had any TEAE that resulted in discontinuation from the study.

“In conclusion, dupilumab significantly improved moderate or severe exacerbations, lung function, quality of life, and symptoms in patients with moderate or severe COPD with type 2 inflammation,” said Surya Bhatt, MD, during a presentation of the poster.