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A biologic treatment for COPD - MORE I CAN MOMENTS 1

INDICATION

DUPIXENT is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

For additional information, please click below for the SmPC.

SmPC

TARGET
TYPE 2 INFLAMMATION
REDUCE
EXACERBATIONS
IMPROVE
HOW PATIENTS BREATHE AND FEEL
Discover the science behind DUPIXENT Explore the efficacy results Learn more

MOD/MOA

DUPIXENT IS THE FIRST AND ONLY BIOLOGIC TO TARGET TYPE 2 INFLAMMATION IN COPD1

Watch to learn how DUPIXENT works

IL-4 and IL-13 are key and central cytokines of type 2 inflammation2

IL4_Cytokine

IL-4 perpetuates underlying type 2 inflammation by differentiating Th0 into Th2.3

IL13_Cytokine

IL-13 promotes goblet cell hyperplasia and mucus hypersecretion.3

Systemic Inflammation3

Local Inflammation3-6

  • Eosinophil trafficking
  • B cell class switching
  • Mast cell degranulation
  • Mucus hypersecretion
  • Airway remodeling
  • Airway smooth muscle hypertrophy
  • Epithelial barrier dysfunction
  • Parenchymal destruction

Hallmark Symptoms7

  • Dyspnea
  • Cough
  • Sputum production

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DUPIXENT, through dual inhibition of IL-4 and IL-13, when used in combination with optimized inhaled therapy,a demonstrated an improvement in symptoms.1,8

Patient ID

ARE YOUR PATIENTS READY FOR MORE I CAN MOMENTS?

Your patient may be a good candidate for DUPIXENT1,7-9

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A raised blood eosinophil level is recognized by the 2024 GOLD Report as a clinically useful biomarker in identifying COPD with type 2 inflammation.7

See Felix’s and Rita’s clinical histories.

Before_Felix

Felix’s clinical history
Age 63

“It’s hard to make it through a workday. I have to sit down and rest before I can finish my mail route. And coughing up so much mucus is tough. I want to work until I’m 70 and enjoy retirement with my family, but I'm not sure my COPD will allow that.”

  • On optimized inhaled therapy (ICS, LAMA, LABA; 1 dose per day)
  • Evidence of type 2 inflammation1,7: raised blood EOS levels (310 cells/μL)
  • 2 moderate exacerbations requiring treatment with OCS in the past year
  • Quit smoking at age 43, 15 pack-year history
  • 4 years since COPD diagnosis
  • FVC: 2.7 L; FEV1/FVC: 0.67; post-BD FEV1: 1.8 L (65% predicted)

Treatment goal:
Improve breathing, reduce mucus, enjoy quality time with family.

Treatment challenge:
Felix remains symptomatic despite being on optimized inhaled therapy for 14 months.

Before_Rita

Rita’s clinical history
Age 74

“I was in the ICU earlier this year. I used to get out to run errands, but now I’m chained to oxygen at home. I can barely make it to my mailbox. I’m scared that if I go back into the hospital, I might not come home again.”

  • On optimized inhaled therapy (LAMA, LABA; 1 dose per day)
  • Evidence of type 2 inflammation1,7: raised blood EOS levels (480 cells/μL)
  • 1 severe exacerbation requiring hospitalization in the past year
  • Quit smoking at age 73, 35 pack-year history
  • 2 years since COPD diagnosis
  • FVC: 2.5 L; FEV1/FVC: 0.52; post-BD FEV1: 1.3 L (48% predicted)

Treatment goal:
Reduce exacerbation risk, improve quality of life, celebrate simple moments.

Treatment challenge:
Rita recently quit smoking after several attempts, but her exacerbations have been severe. With each exacerbation increasing the risk of more, the situation is urgent.10

Efficacy

MORE I CAN MOMENTS
for patients still symptomatic on optimized inhaled therapya

A BIOLOGIC TREATMENT FOR COPD

Efficacy Exacerbations

MORE I CAN moments with reduced exacerbations1

DUPIXENT SIGNIFICANTLY REDUCED EXACERBATIONS1

Moderate or severe exacerbations are a major contributor to poor outcomes in COPD8

Exacerbation rate reduction

Exacerbations_Chart

Annualized rate of moderate or severe COPD exacerbations at Week 52 (primary endpoint)1

NOTUS_exacerbations_graph

NOTUS Trial

Reduction in moderate or severe exacerbation rate1,d

Adding DUPIXENT to optimized inhaled therapya provided a reduction in moderate or severe exacerbations1

BOREAS_exacerbations_graph

BOREAS Trial

Reduction in moderate or severe exacerbation rate1,d

Adding DUPIXENT to optimized inhaled therapya provided a reduction in moderate or severe exacerbations1

Subgroup efficacy

Exacerbation reduction seen across key patient subgroups regardless of1,8,9:

Efficacy Lung Function

MORE I CAN moments with improved breathing1

DUPIXENT PROVIDED RAPID AND SUSTAINED IMPROVEMENT IN PATIENTS’ BREATHING

Lung function improved as early as Week 2, sustained through Week 52

BOREAS_Exacerbations_Chart

BOREAS Trial

Rapid and sustained improvement in lung function1,a,b

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Improvement as early as Week 2

Improvement_Lungfunc_Chart

NOTUS Trial

Rapid and sustained improvement in lung function1,a,b

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Improvement as early as Week 2

Quality of life

Improved quality of life with DUPIXENT for MORE I CAN moments1

DUPIXENTa SIGNIFICANTLY IMPROVED QUALITY OF LIFE FOR MOST COPD PATIENTS1,8

BOREAS Trial

51.5% of patients on DUPIXENTa achieved a clinically meaningful response in SGRQ total score (≥4 points) vs 43.1% with placebo at Week 52 (P=0.009)8,b,c

NOTUS trial

In the NOTUS trial, 51.4% of patients on DUPIXENTa achieved a nominally improved SGRQ total score vs 46.5% with placebo at Week 52 (OR: 1.16; 95% CI: 0.86, 1.58)9,b

QoL_SGRQ_Chart

Improvement in quality of life (SGRQ)1,8,b

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3.4 differenced

In the NOTUS trial, patients on DUPIXENTa experienced a nominal LSM difference in SGRQ total score compared with placebo of 3.37 points (95% CI: -5.81, -0.93; P=0.007).1

Cough_Icon

Cough

Sputum_Icon

Sputum

Breathlessness_Icon

Breathlessness

Wheezing_Icon

Wheezing

Chest_Exacerbations_Icon

Exacerbations

Activities_Icon

Activities of daily living

Medication_Icon

Medication

Symptom Improvement

Improve symptoms for MORE I CAN moments with DUPIXENT8

DUPIXENT IMPROVED HALLMARK SYMPTOMS THAT IMPACT PATIENT WELL-BEING

E-RS-COPD_symptom_graph

BOREAS Trial

Symptoms were assessed using E-RS:COPD8,12-14,a-c

All components of E-RS:COPD score improved

Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score, an 11-item patient-reported diary used to measure the effect of a treatment on the severity of respiratory symptoms in patients with stable COPD, was used at baseline and Week 52. E-RS:COPD utilizes the 11 respiratory symptom items contained in the 14-item EXACT. Scores range from 0-40, with a lower score indicating lower disease severity.

E-RS:COPD scores declined8,b,d

E-RS-COPD_scores_declining_graphic

In the NOTUS trial, E-RS:COPD scores declined by 2.4 points.9

E-RS:COPD total clinically meaningful score change threshold is ≥2.0-point reduction.15

Study Design

DUPIXENT enrolled COPD patients with type 2 inflammation across 2 clinical trials1,7

Clincal_Trail_Design

BOREAS AND NOTUS CLINICAL TRIALS

ASSESSED SAFETY, TOLERABILITY, AND EFFICACY IN COPD PATIENTS WITH TYPE 2 INFLAMMATION1,7

All patients received background SOC (ICS+LAMA+LABA, or LAMA+LABA if ICS was not appropriate)1,a

Two phase 3, multicenter, international, double-blind, randomized, placebo-controlled trials in patients with uncontrolled COPD1,8,9

PRIMARY ENDPOINT

Week 52

Annualized rate of moderate or severe COPD exacerbations

SELECT SECONDARY AND OTHER ENDPOINTS

Week 12
Week 52

Change in lung function (pre-BD FEV1) from baseline

Week 52

Change in SGRQ total score from baseline

Week 52

Percentage of patients with SGRQ total score improvement ≥4 points

Week 12
Week 52

Change in lung function (pre-BD FEV1) from baseline among patients with a baseline FeNO ≥20 ppb

Week 52

Annualized rate of moderate or severe exacerbations of COPD among patients with a baseline FeNO ≥20 ppb

Week 52

Change in E-RS:COPD total score from baseline

Key Inclusion Criteria8,9

  • Physician-diagnosed COPD for ≥12 months prior to randomization
  • Current or former smokers with a smoking history of ≥10 pack-years
  • Signs or symptoms of chronic bronchitis (chronic productive cough) for ≥3 months
  • ≥1 exacerbation while the patient was on SOC
  • mMRC dyspnea scale grade ≥2
  • Blood EOS ≥300 cells/μL
  • ≥2 moderate or ≥1 severe exacerbations within the year prior to screening
  • Background triple therapy (ICS+LAMA+LABA) 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 ICS was not appropriate

 

Key Exclusion Criteria8,9

  • Physician-diagnosed COPD for <12 months prior to randomization
  • Diagnosis or history of asthma according to the GINA guidelines

For the full list of inclusion and exclusion criteria, see SmPC.

Patient characteristics at baseline1

Parameter

BOREAS (n=939)

NOTUS (n=935)

Mean age (years) (± SD)

65.1 (8.1)

65.0 (8.3)

Male (%)

66.0

67.6

White (%)b

84.1

89.6

Mean smoking history (pack-years) (± SD)

40.5 (23.4)

40.3 (27.2)

Current smokers (%)

30

29.5

Emphysema (%)

32.6

30.4

Mean duration of COPD (years) (± SD)

8.8 (6.0)

9.3 (6.4)

Mean number of moderatec or severed exacerbations in previous year (± SD)

2.3 (1.0)

2.1 (0.9)

Mean number of severe exacerbationsd in previous year (± SD)

0.3 (0.7)

0.3 (0.6)

Background COPD medications at randomization: ICS/LAMA/LABA (%)

97.6

98.8

Mean postbronchodilator FEV1/FVC ratio (± SD)

0.5 (0.1)

0.5 (0.1)

Mean prebronchodilator FEV1 (L) (± SD)

1.3 (0.5)

1.4 (0.5)

Mean postbronchodilator FEV1 (L) (± SD)

1.4 (0.5)

1.5 (0.5)

Mean percent predicted postbronchodilator FEV1 (%) (± SD)

50.6 (13.1)

50.1 (12.6)

Mean percent predicted postbronchodilator FEV1 <50% (%) (± SD)

467 (49.7)

478 (51.3)

Mean SGRQ total score (± SD)

48.4 (17.4)

51.5 (17.0)

Mean E-RS:COPD [total score] (± SD)

12.9 (7.1)

13.3 (7.0)

Mean BODE index score (± SD)

4.1 (1.7)

4.0 (1.6)

Mean FeNO (ppb) (± SD)

24.3 (22.4)

24.6 (26.0)

Mean baseline blood eosinophil count (cells/μL) (± SD)

401 (298)

407 (336)

Median baseline blood eosinophil count (cells/μL) (Q1-Q3)

340 (240-460)

330 (220-460)

Safety

BOREAS safety

BOREAS safety8,a

DUPIXENT (n=469)

Placebo (n=470)

Any AE

77%

76%

Any SAE

14%

16%

Any AE leading to death

2%

2%

Any AE leading to permanent study intervention discontinuation

3%

3%

Major adverse cardiovascular eventb

1%

2%

AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP

Nasopharyngitis

9%

10%

Upper respiratory tract infection

8%

10%

Headache

8%

7%

COPD

6%

6%

COVID-19

4%

6%

Hypertension

4%

6%

Diarrhea

5%

4%

Back pain

5%

3%

NOTUS safety

NOTUS safety9,c

DUPIXENT (n=469)

Placebo (n=464)

Any AE

67%

66%

Any SAE

13%

16%

Any AE leading to death

3%

2%

Any AE leading to permanent study intervention discontinuation

4%

3%

Major adverse cardiovascular eventb

1%

2%

AEs OCCURRING IN ≥5% OF PATIENTS IN EITHER GROUP

COVID-19

9%

8%

Headache

8%

7%

COPD

5%

8%

Nasopharyngitis

6%

5%

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DUPIXENT IS NOT AN IMMUNOSUPPRESSANT AND NOT A STEROID.1

A DEMONSTRATED SAFETY PROFILE ACROSS 6 INDICATIONS1

System Class

Adverse Reaction

Frequencyd

Blood and lymphatic system disorders

Eosinophilia

Common

Immune system disorders

Angioedemae

Anaphylactic reaction, serum sickness reaction, serum sickness-like reaction

Uncommon

Rare

Skin and subcutaneous tissue disorders

Facial rashe

Uncommon

Musculoskeletal and connective tissue disorders

Arthralgiae

Common

General disorders and administration site conditions

Injection site reactions (includes erythema, edema, pruritus, pain, swelling, and bruising)

Common

Common adverse events occurring predominantly in atopic dermatitis clinical trials

Infections and infestations

Conjunctivitis, oral herpes

Common

Eye disorders

Conjunctivitis allergic

Common

Keratitis,e blepharitis,f eye pruritus,f dry eyef

Uncommon

Ulcerative keratitise,f

Rare

Dosing

THE FLEXIBILITY OF AT-HOME OR IN-OFFICE ADMINISTRATION

Dosing

Fixed dosing schedule with no loading dose1

Two ways to provide confident administration to your patients

DUPIXENT Pre-filled Pen1

DUPIXENT Pre-filled Syringe1

  • Single-press auto-injector
  • A clear 2-step process
  • Visual and audible feedback
  • Compact and convenient to carry
  • Hidden needle
  • Manual control of injection speed
  • Finger grip for comfort
  • Visual confirmation of injection delivery
  • Needle shield
  • Easy-to-carry format
Dosing_pens
Dosing_injectors

DUPIXENT is intended for use under the guidance of a healthcare provider1

  • DUPIXENT can be injected by a patient or caregiver at home after training in a subcutaneous injection technique using the auto-injection pen (for adults and adolescents) or pre-filled syringe
  • Physicians or nurses should provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use, according to the Instructions for Use
  • DUPIXENT can be administered in the office under the guidance of a healthcare provider if the patient or caregiver is not an appropriate candidate to administer the injection

SmPC

Legacy

1 million

7 YEAR LEGACY ACROSS INDICATIONS DRIVEN BY TYPE 2 INFLAMMATION1
DUPIXENT has transformed many lives with real-world use in patients as young as 6 months1,16

AD_Icon

Atopic dermatitis
uncontrolled severeb

Asthma_Icon

Asthma
severe type 2 asthma or OCS-dependentc

NP_Icon

CRS with nasal polyps
severe inadequately controlled

PN_Icon

Prurigo nodularis
uncontrolled moderate to severe

Esophagitis_Icon

Eosinophilic esophagitis
inadequately controlled

COPD_Icon

COPD
uncontrolled while on optimized inhaled therapyd

 

ATOPIC DERMATITIS

DUPIXENT is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

DUPIXENT is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.

ASTHMA

DUPIXENT is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

DUPIXENT is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

CRS WITH NASAL POLYPS (CRSwNP)

DUPIXENT is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

PRURIGO NODULARIS (PN)

DUPIXENT is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

EOSINOPHILIC ESOPHAGITIS (EoE)

DUPIXENT is indicated for the treatment of eosinophilic esophagitis in adults and children 1 year or older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

DUPIXENT is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

AE, adverse event
BD, bronchodilator
BL, baseline
BODE, body mass index, airflow obstruction, dyspnea, and exercise capacity
COPD, chronic obstructive pulmonary disease
CRS, chronic rhinosinusitis
EoE, eosinophilic esophagitis
EOS, eosinophil
E-RS:COPD, Evaluating Respiratory Symptoms in COPD
EXACT, EXAcerbations of COPD Tool
FeNO, fractional exhaled nitric oxide
FEV1, forced expiratory volume in 1 second
FVC, forced vital capacity
GINA, Global Initiative for Asthma
GOLD, Global Initiative for Chronic Obstructive Lung Disease
ICS, inhaled corticosteroid
ICU, intensive care unit
LABA, long-acting beta agonist
LAMA, long-acting muscarinic antagonist
LSM, least squares mean
mMRC, Modified Medical Research Council
OCS, oral corticosteroid
OR, odds ratio
Q2W, once every 2 weeks
SAE, serious adverse event
SC, subcutaneous
SGRQ, St George’s Respiratory Questionnaire
SOC, standard of care

References

Resources

Watch to learn how DUPIXENT works

DUPIXENT, through dual inhibition of IL-4 and IL-13, when used in combination with optimized inhaled therapy,a demonstrated an improvement in symptoms.1,8