)
Two phase 3 trials evaluated the efficacy of DUPIXENT + SOCb administered every
2 weeks in patients with inadequately controlled COPD
Standard of care was triple inhaled therapy (LAMA+LABA+ICS).1,4
BOREAS and NOTUS clinical study designs
52 weeks
SC 300 mg Q2W + SOCb
SC Q2W + SOCb
PATIENTS WITH A HISTORY OF ASTHMA WERE EXCLUDED FROM THE BOREAS AND NOTUS TRIALS2,3
endpoint2,3 Week 52 Annualized rate of moderate or severe COPD exacerbations
Secondary
endpoints2,3
Week 52
Change in lung function (pre-bronchodilator FEV1) from baseline Change in SGRQ total score from baseline Percentage of patients with SGRQ total score improvement of ≥4 pointsa1874 patients were enrolled in the BOREAS (N=939) and NOTUS (N=935) trials.1
b98% received LAMA+LABA+ICS in BOREAS and 99% in NOTUS.1
DUPIXENT trials included a broad population of patients with inadequately controlled COPD
BACKGROUND THERAPY
Background triple therapy (LAMA+LABA+ICS) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; double therapy (LAMA+LABA) allowed if an ICS was contraindicated
BIOMARKER OF TYPE 2 INFLAMMATION
Blood EOS levels ≥300 cells/µL
EXACERBATION HISTORY
≥2 moderate or ≥1 severe exacerbations within the year prior to screening, ≥1 exacerbation while the patient was on the standard of carea
Lung function
Post-bronchodilator FEV1/FVC ratio <0.7 and post-bronchodilator FEV1 of 30% to 70% predicted
Smoking status
Current or former smokers with a smoking history of ≥10 pack-years
PRODUCTIVE COUGH
Symptoms of chronic productive cough for at least 3 months in the past year
ASTHMA HISTORY
Patients with a history of asthma were excluded from the trials
Patient characteristics at baseline1
| Parameter | BOREAS (n=939) |
notus (n=935) |
|---|---|---|
| Emphysema (%) | 32.6 | 30.4 |
| Mean age (years) (± SD) | 65.1 (8.1) | 65.0 (8.3) |
| Male (%) | 66.0 | 67.6 |
| White (%) | 84.1 | 89.6 |
| Mean smoking history (pack-years) (± SD) | 40.5 (23.4) | 40.3 (27.2) |
| Current smokers (%) | 30 | 29.5 |
| Mean number of moderate or severe exacerbations in previous year (± SD)a | 2.3 (1.0) | 2.1 (0.9) |
| Background COPD medications at randomization: ICS/LAMA/LABA (%) | 97.6 | 98.8 |
| Mean percent predicted post-bronchodilator FEV1 (%) (± SD) | 50.6 (13.1) | 50.1 (12.6) |
| Mean SGRQ total score (± SD) | 48.4 (17.4) | 51.5 (17.0) |
| Mean baseline blood eosinophil count (cells/µL) (± SD) | 401 (298) | 407 (336) |
|
BOREAS |
- |
|---|
| Emphysema (%) 32.6 |
| Mean age (years) (± SD) 65.1 (8.1) |
| Male (%) 66.0 |
| White (%) 84.1 |
| Mean smoking history (pack-years) (± SD) 40.5 (23.4) |
| Current smokers (%) 30 |
| Mean number of moderate or severe exacerbations in previous year (± SD)a 2.3 (1.0) |
| Background COPD medications at randomization: ICS/LAMA/LABA (%) 97.6 |
| Mean percent predicted post-bronchodilator FEV1 (%) (± SD) 50.6 (13.1) |
| Mean SGRQ total score (± SD) 48.4 (17.4) |
| Mean baseline blood eosinophil count (cells/µL) (± SD) 401 (298) |
|
NOTUS |
+ |
|---|
aModerate exacerbations were exacerbations that resulted in treatment with a systemic glucocorticoid, an antibiotic agent, or both. Severe exacerbations were
exacerbations that led to hospitalization or an emergency medical care visit or that resulted in death.1
COPD, chronic obstructive pulmonary disease; EOS, eosinophil; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; LABA, long-acting beta agonist; LAMA, long-acting muscarinic antagonist; Q2W, once every 2 weeks; SC, subcutaneous; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire; SOC, standard of care.
Learn more about the efficacy and safety data
Learn more about dosage and administration options for patients on DUPIXENT