Indication

DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with Eosinophilic Esophagits (EoE).

Additional indications

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 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.
Chronic rhinosinusitis with nasal polyposis (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.

CRS, chronic rhinosinusitis.

Prurigo Nodularis for the treatment of adult patients with prurigo nodularis (PN).

EoE is a chronic, progressive disease of the esophagus driven by type 2 inflammation^1-3

Many patients with eosinophilic esophagitis (EoE) remain uncontrolled with the current standard of care, leading to high disease burden and increased risk of progression^4-7

Patients need a therapy that treats the underlying type 2 inflammation that drives EoE

^e61% of adult patients repeated treatment with oral topical steroids at least once.

Dupixent—the first and only biologic targeting type 2 inflammation in EoE

Type 2 inflammation is the underlying driver in the majority of patients with eosinophilic esophagitis (EoE)^3,12

Dupixent works locally and systemically to target type 2 inflammation and control eoe activity^13-16

Rapid improvement in swallowing for patients and sustained symptom reduction

DUPIXENT significantly improved swallowing vs placebo as early as Week 4, with lasting improvement through Week 24 and Week 52¹³

Percentage reduction in DSQ total score from baseline through Week 24 (co-primary endpoint) and Week 52

The Dysphagia Symptom Questionnaire (DSQ) is a patient-reported assessment that measures the frequency and severity of dysphagia. DSQ scores range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia.

The difference Dupixent can make in the disease burden of EoE

TREET study design, Part A, A/C¹³

82% of patients achieved substantial histological response by week 52¹⁷

DUPIXENT significantly reduced peak esophageal intraepithelial eosinophil count vs placebo at Week 24 with sustained results through Week 52^13,17

Peak esophageal intraepithelial eosinophil count (eosinophils per high-power field, or EOS/HPF) determines histologic outcome, using both percent change in peak EOS/HPF as well as proportion of patients achieving a treatment response.
^aSecondary endpoints were proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 EOS/HPF at Week 24, proportion of patients achieving <6 EOS/HPF at Weeks 24 and 52.
^b 82% of patients who received DUPIXENT from baseline achieved histological response (n=34), and 70% of patients who switched to DUPIXENT from placebo at Week 24 achieved histological response (n=30).
^c 56% of patients who received DUPIXENT from baseline achieved histological remission at Week 52 (n=34), and 60% of patients who switched to DUPIXENT from placebo at Week 24 achieved histological remission (n=30).
^dCoprimary endpoint was the proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 EOS/HPF at Week 24.

The histological normalization results

^a29% of patients who received DUPIXENT from baseline achieved histological normalization at Week 52 (n=34), and 27% of patients who switched to DUPIXENT from placebo at Week 24 achieved histological normalization (n=30).

The study design

TREET study design, Part A, A/C¹³

Visible improvement in severity of endoscopic signs by targeting deep in the tissue

DUPIXENT significantly improved endoscopic findings (EREFS) vs placebo at Week 24, with continued improvement through Week 52^13,17

EoE-Endoscopic Reference Score (EREFS) correlates with proximal, mid, and distal eosinophilia and accurately measures the disease severity and treatment response of 5 endoscopic findings—edema (0–2), rings (0–3), exudates (0–2), furrows (0–2), and strictures (0–1)— grading separately for each third of the esophagus. Scores range from 0 to 18, with a higher score indicating higher severity/presence
^aSecondary endpoint was change from baseline in EREFS at Week 24.
^b51% reduction at Week 24 with DUPIXENT (n=42) vs 5% with placebo (n=29) (P<0.001).
^c63% reduction in patients who received DUPIXENT from baseline (n=35), and 65% reduction in patients who switched to DUPIXENT from placebo at Week 24 (n=30).

THE STUDY DESIGN

TREET study design, Part A, A/C¹³

Patients feel liberated from EoE with transformative change to quality of life

DUPIXENT signficantly improved quality of life vs placebo at Week 24²⁰
 

Symptom frequency at week 24

Improvement in symptom frequency at Week 24

2X Improvement in symptom frequency with Dupixent vs placebo (p<0.01)^a

The 5-Item EoE Symptom Questionnaire (EoE-SQ-Frequency) is a patient-reported assessment that measures the frequency of symptoms other than dysphagia or swallowing pain. The maximum score is 25, with higher scores indicating greater symptom severity and frequency.

^aAs measured by EoE-SQ-Frequency, DUPIXENT score was -3.4 at Week 24 vs -1.7 for placebo.

Disease burden at week 24

Symptom frequency at week 24

Improvement in symptom frequency at Week 24

2X Improvement in symptom frequency with Dupixent vs placebo (p<0.01)^a

Improvement in disease burden at Week 24

~2.5X Improvement in disease burden with Dupixent vs placebo (p<0.01)^b
 

Emotional

• Bothered by symptoms of
• EoE Worried about trouble swallowing
• Worried about choking

Productivity

• Difficulty keeping up with things at work or school
• Missing work or school

Social

• Embarrassed
• Worried about trouble swallowing while in a public place
• Difficulty taking part in social activities that involve eating food
• Impact on relationships with family and friends

Sleep

• Sleep disruption

The 11-Item EoE Impact Questionnaire (EoE-IQ) is a patient-reported assessment that measures health-related impacts of EoE: Patients record responses to questions that evaluate quality of life using a 5-point response option: ranging from “Not at all” to “Extremely.” The maximum score is 5, with higher scores indicating a greater impact on quality of life.

^bAs measured by EoE-IQ, DUPIXENT score was -0.61 at Week 24 vs -0.25 for placebo.

The study design
 

TREET study design, Part A, A/C¹³

Dupixent offers EoE patients more than short-term options for their uncontrolled symptoms

Established safety in adults and adolescents with eosinophilic esophagitis¹³

DUPIXENT is a fully human monoclonal antibody with a safety pro"le comparable to placebo^13,a

Adverse events in EoE, CRSwNP, asthma, and atopic dermatitis clinical trials^a

Safety heritage across multiple indications and real-world use in [750,000] adult, adolescent, and pediatric patients²¹

^aDUPIXENT was studied in 12 randomized, placebo-controlled trials, including atopic dermatitis, asthma, CRSwNP, and EoE patients. The pivotal controlled studies involved 4,206 patients receiving dupilumab and 2,326 patients receiving placebo during the controlled period.

^bEye disorders and oral herpes occurred predominantly in atopic dermatitis studies.
^cThe frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies.
^dFrom postmarketing reporting.

AE, adverse events; MedDRA, Medical Dictionary for Regulatory Activities.

AE occurring predominantly in atopic dermatitis clinical trials
 

Adverse events in EoE, CRSwNP, asthma, and atopic dermatitis clinical trials^a

^aEye disorders and oral herpes occurred predominantly in atopic dermatitis studies.
^bThe frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies.
^c From postmarketing reporting.

Dupixent—transform the course of eoe with rapid and sustained results

DUPIXENT targets type 2 inflammation, the underlying cause of EoE, to deliver rapid and sustained improvements across key clinical disease measures^3,12,13
 

The first and only biologic targeting type 2 inflammation in EoE

Clinical: Reduced frequency and severity of dysphagia

up to 75^% reduction in dysphagia at Week 52^13,a

Histologic: Achieved remission in peak esophageal intraepithelial eosinophil count

up to 82^% of patients achieved histological response (<15 EOS/HPF) at Week 52^17,b

Endoscopic: Reduced endoscopic signs of inflammation and fibrosis (strictures)

up to 63^% reduction in dysphagia at Week 52^13,a

^a75% reduction in patients who received DUPIXENT from baseline (n=40), and 66% reduction in patients who switched to DUPIXENT from placebo at Week 24 (n=37).
^b 82% of patients who received DUPIXENT from baseline achieved histological response (n=34), and 70% of patients who switched to DUPIXENT from placebo achieved histological response (n=30).
^c63% reduction in patients who received DUPIXENT from baseline (n=35), and 65% reduction in patients who switched to DUPIXENT from placebo at Week 24 (n=30).

Histological normalization is possible with Dupixent

DUPIXENT significantly normalized peak esophageal intraepithelial eosinophil count vs placebo at Week 24, with continued improvement at Week 52¹⁸

Peak esophageal intraepithelial eosinophil count (eosinophils per high-power field, or EOS/HPF) determines histologic outcome, using both percent change in peak EOS/HPF as well as proportion of patients achieving a treatment response.
^a29% of patients who received DUPIXENT from baseline achieved histological normalization at Week 52 (n=34), and 27% of patients who switched to DUPIXENT from placebo at Week 24 achieved histological normalization (n=30).

Transformative improvement in histological severity beyond reducing eosinophil count

DUPIXENT signficantly improved histology vs placebo at Week 24, with sustained improvements through Week 52¹³

Improvements in degree and extent of histological severity were sustained through Week 52

The Eosinophilic Esophagitis Histologic Scoring System (EoE-HSS) measures histologic changes in the esophagus beyond eosinophil count and includes features of epithelial barrier function and remodeling. The EoE-HSS grades 8 features of EoE to quantify frequency, severity, and extent of esophageal abnormality.
Histological degree of severity (grade) and histological extent of severity (stage) are scored using a 4-point scale for each feature (0=normal, 3=most severe or extensive). The maximum possible grade or stage score for each biopsy is 24.
^aSecondary endpoints were severity of histological abnormalities (grade) and extent of histological abnormalities (stage) at Week 24.

Patients feel "Much better" after taking dupixent

DUPIXENT offers patients improvement they can feel vs placebo at Week 24²⁰

Patient Global Impression of Change (PGIC)

The Patient Global Impression of Change (PGIC) is a patient-reported assessment that measures their feelings regarding the dysphagia symptoms of EoE. Patients record responses to questions on a scale ranging from “very much better” to “very much worse.”

Simple weekly dosing

You decide: patients administer at home or you administer at the office¹³
 

Dosage regimen in adults and pediatric patients

Administration methods

300 mg dose shown

^a300 mg=2 mL solution.
^bDUPIXENT 300 mg weekly has not been studied in patients with EoE who weigh less than 40 kg.

How to use Dupixent

How to use DUPIXENT

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

A patient or caregiver may inject DUPIXENT after receiving training in subcutaneous injection technique using the pre-filled syringe or pre-filled pen

• In pediatric patients 12 years of age and older, it is recommended that DUPIXENT be administered by or under the supervision of an adult
• 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 is not an appropriate candidate for at-home administration

Missed dose information
If a weekly dose is missed, administer the dose as soon as possible, starting a new schedule based on this date

Dupixent was studied in adolescent and adult patients with EoE

The clinical trial program consisted of a 24-week treatment study followed by a 28-week extended active-treatment period¹³

TREET study design, Part A, A/C¹³