)
Two phase 3 trials
with over 1800 patients in total evaluated the efficacy of DUPIXENT + triple
therapy
administered every 2
weeks in patients with
inadequately controlled COPD and an eosinophilic phenotype
Triple therapy consisted of LAMA+LABA+ICS.1
BOREAS and NOTUS clinical study designs
52 weeks
SC 300 mg Q2W + triple
therapy
SC Q2W + triple therapy
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
EXACERBATION HISTORY
≥2 moderate or ≥1 severe exacerbations within the year prior to screening, ≥1 exacerbation while the patient was on triple therapy
BIOMARKER OF TYPE 2 INFLAMMATION
Blood EOS levels ≥300 cells/µL
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
LUNG FUNCTION
Post-bronchodilator FEV1/FVC ratio <0.7 and
post-bronchodilator FEV1 of 30% to 70% predicted
ASTHMA HISTORY
Patients with a history of asthma were excluded from the trials
Patient characteristics at baseline1
40% of patients had blood EOS
<300 cells/µL at baseline. Blood EOS
levels fluctuate frequently4,5
| 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)c | 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)c 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 |
+ |
|---|
cModerate 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.1-3
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.
Learn more about the efficacy and safety data
Learn more about dosage and administration options for patients on DUPIXENT