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Study design

STUDIED IN TWO PHASE 3 CLINICAL TRIALS WITH OVER 1,800 PATIENTS1,3,4,b

Two phase 3 trials evaluated the efficacy of DUPIXENT + SOCc administered every 2 weeks in patients with inadequately controlled COPD

Standard of care was triple inhaled therapy (LAMA+LABA+ICS).1,5

BOREAS and NOTUS
Clinical Study Designs1

Screening
Randomized
Treatment period:
52 weeks
Follow-up
Week -4 Baseline Week 52 Week 64

PATIENTS WITH A HISTORY OF ASTHMA WERE EXCLUDED FROM THE BOREAS AND NOTUS TRIALS3,4

Primary
endpoint3,4 Week 52 Annualized rate of moderate or severe COPD exacerbations
SELECT Secondary
endpoints3,4
Week 12
Week 52 Change in lung function
(pre-bronchodilator FEV1) from baseline
Week 52 Change in SGRQ total score from baseline
Week 52 Percentage of patients with SGRQ total score improvement of ≥4 points

b1874 patients were enrolled in the BOREAS (N=939) and NOTUS (N=935) trials.1

c98% received LAMA+LABA+ICS in BOREAS and 99% in NOTUS.1

DUPIXENT TRIALS INCLUDED A BROAD POPULATION OF PATIENTS WITH INADEQUATELY CONTROLLED COPD

Select Inclusion Criteria3,4

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 the standard of cared

BIOMARKER OF TYPE 2 INFLAMMATION
Blood EOS levels ≥300 cells/µL

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

Select Exclusion Criteria3,4

ASTHMA HISTORY
Patients with a history of asthma were excluded from the trials

Not an actual
DUPIXENT patient.

dModerate exacerbations were defined as exacerbations that resulted in treatment with a systemic glucocorticoid, an antibiotic agent, or both. Severe exacerbations were defined as exacerbations that led to hospitalization or an emergency medical care visit or that resulted in death.3,4

Patient characteristics at baseline1

BOREAS
(N=939)

 +

NOTUS
(N=935)

 +

eModerate exacerbations were defined as exacerbations that resulted in treatment with a systemic glucocorticoid, an antibiotic agent, or both. Severe exacerbations were defined as exacerbations that led to hospitalization or an emergency medical care visit or that resulted in death.1

Efficacy

DUPIXENT CAN HELP IMPROVE MULTIPLE MEASURES OF COPD

Up to 52 weeks of efficacy and safety data demonstrated in patients with inadequately controlled COPD and an eosinophilic phenotype1

Choose a category to learn more

DUPIXENT SIGNIFICANTLY REDUCED
COPD EXACERBATIONS1,3,4,f

When added to standard of care, DUPIXENT significantly reduced the annualized rate of moderate or
severe exacerbations

Annualized rate of moderate or severe COPD exacerbations at Week 52 (primary endpoint)

Standard of care was triple inhaled therapy (LAMA+LABA+ICS).1,5

fModerate exacerbations were defined as exacerbations that resulted in treatment with a systemic glucocorticoid, an antibiotic agent, or both. Severe exacerbations were defined as exacerbations that led to hospitalization or an emergency medical care visit or that resulted in death.1

gRate ratio vs placebo: 0.71 (95% CI: 0.58, 0.86).1

hRate ratio vs placebo: 0.66 (95% CI: 0.54, 0.82).1

DUPIXENT SHOWED IMPROVEMENT IN LUNG FUNCTION1

Lung function improvement
sustained through Week 52

Post-bronchodilator FEV1

BOREAS Trial

Change in post-bronchodilator FEV1 from baseline at Week 12 and Week 52 (ITT population; secondary endpoint)1,3

NOTUS Trial

Patients administered DUPIXENT + SOC saw numerical improvement in post-bronchodilator FEV1 of 134 mL at Week 12 (n=470) and 127 mL at Week 52 (n=362), compared with 67 mL at Week 12 (n=465) and 59 mL at Week 52 (n=359) in patients receiving placebo + SOC (LSM change from baseline, ITT population)1

Post-bronchodilator lung function results are descriptive. Definitive conclusions cannot be made.

Pre-bronchodilator FEV1

Significant improvements of similar magnitude were observed in change from baseline in pre-bronchodilator FEV1 at Weeks 12 and 52 in subjects treated with DUPIXENT compared to placebo across the BOREAS and NOTUS trials.1

Standard of care was triple inhaled therapy (LAMA+LABA+ICS).1,5

DUPIXENT IMPROVED COPD
PATIENTS’ DAILY QUALITY OF LIFE1,3

Improvement as measured by SGRQ6

BOREAS Trial
51%

of patients reported a clinically meaningful (≥4-point) improvement at
Week 52 with DUPIXENT vs 43% for placebo
(N=939; OR: 1.44; 95% CI: 1.10, 1.89; P =0.009)1,3

NOTUS Trial

51% responder rate at Week 52 for subjects treated with DUPIXENT vs 47% for placebo (N=721; OR: 1.16; 95% CI: 0.86, 1.58)1,4

NOTUS results are descriptive. Definitive conclusions cannot be made.

DUPIXENT SIGNIFICANTLY REDUCED SGRQ SCOREs–LOWER SGRQ SCORES INDICATE IMPROVED QUALITY OF LIFE1,3

Standard of care was triple inhaled therapy (LAMA+LABA+ICS).1,5

The sgrq measures the qualitative impact of copd3,6

SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and
perceived well-being in patients with COPD

Symptoms

Cough, sputum production,
breathlessness, and wheezing

Activity

Disruption of daily
physical activity

Impacts

Disturbance to
psychosocial function

Significant improvement in SGRQ total score at Week 521,3
BOREAS Trial
NOTUS Trial

In NOTUS, patients receiving DUPIXENT + SOC (n=362) experienced -9.8 reduction in total SGRQ score vs -6.4 with
placebo + SOC (n=359) (LSM difference: -3.4 [95% CI: -5.8, -0.9]).4

NOTUS results are descriptive. Definitive conclusions cannot be made.

safety

DEMONSTRATED SAFETY PROFILE IN COPD THROUGH 52 WEEKS1

Adverse reaction BOREAS and NOTUS
DUPIXENT 300 mg Q2W
n=938
n (%)		 Placebo
n=934
n (%)
Viral infectioni 133 (14.2) 115 (12.3)
Headache 73 (7.8) 62 (6.6 )
Nasopharyngitis 73 (7.8) 69 (7.4)
Back pain 42 (4.5) 29 (3.1)
Diarrheai 35 (3.7) 30 (3.2)
Arthralgia 29 (3.1) 25 (2.7)
Urinary tract infection 28 (3.0) 18 (1.9)
Local administration reactions 26 (2.8) 6 (0.6)
Injection site reactions 11 (1.2) 2 (0.2)
Rhinitis 24 (2.6) 17 (1.8)
Eosinophiliaj 22 (2.3) 7 (0.7)
Toothache 20 (2.1) 11 (1.2)
Gastritis 19 (2) 7 (0.7)

iConsists of multiple similar terms.

jEosinophila was defined as blood eosinophils ≥3,000 cells/µL or deemed by the investigator to be an adverse event. None met the criteria for serious eosinophilic conditions.

Dosing

NO LOADING DOSE REQUIRED1

ADULTS
300mg
EVERY 2 WEEKS

1 pre-filled pen or syringek

k300 mg=2 mL solution.1

FLEXIBLE AT-HOME OR IN-OFFICE ADMINISTRATION7,8

A patient may self-inject DUPIXENT—or a caregiver may administer DUPIXENT—after training has been provided by a healthcare provider on proper subcutaneous injection technique using the pre-filled syringe or pen.1

It is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use.1

BL, baseline; COPD, chronic obstructive pulmonary disease; EOS, eosinophil; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; ITT, intention-to-treat; LABA, long-acting beta agonist; LAMA, long-acting muscarinic antagonist; LSM, least squares mean; MRC, Medical Research Council; OR, odds ratio; Q2W, once every 2 weeks; SC, subcutaneous; SGRQ, St George’s Respiratory Questionnaire; SOC, standard of care.

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