EoE IS A CHRONIC PROGRESSIVE DISEASE THAT CAN MANIFEST DIFFERENTLY IN CHILDREN2

Children (1-11 years)

  • Abdominal pain
  • Food refusal
  • Heartburn
  • Difficulty
    swallowing
  • Regurgitation
  • Vomiting
  • Acid reflux
  • Food getting
    stuck

Adolescents/Adults (≥12 years)

  • Dysphagia
  • Food impaction
  • Heartburn
  • Nonswallowing
    chest pain
  • Regurgitation

Choose a category to learn more.

STUDY DESIGN

THE PIVOTAL TRIAL ENROLLED CHILDREN AS YOUNG AS 1 YEAR1,3

The efficacy and safety of DUPIXENT were evaluated in patients aged 1‑11 years weighing ≥15 kg in a multipart, phase 3 trial for up to 52 weeks1,3
Study Design1,3,a,b
Part A 24-Week Placebo-Controlled Treatment Period
  • EoE KIDS-Part A: A 16-week, double-blind, placebo-controlled trial. Subjects were randomized to receive either DUPIXENT or placebo at dosing regimens based on body weight: ≥15 to <30 kg (200 mg Q2W) and ≥30 to <60 kg (300 mg Q2W)1,3,a
  • EoE KIDS-Part B: A 36-week active treatment extension study, for a total of 52 weeks of treatment in subjects who were treated with DUPIXENT or placebo completing Part A. Subjects received DUPIXENT at dosing regimens based on body weight: ≥15 to <30 kg (200 mg Q2W), ≥30 to <60 kg (300 mg Q2W), and ≥60 kg (300 mg QW)1,3,a
  • All enrolled subjects were required to have uncontrolled EoE (≥15 intraepithelial EOS/HPF despite an 8-week course of a high-dose PPI) and a history of EoE signs and symptoms1,3

aThe 300 mg Q2W dosing regimen is lower than the recommended dosage of DUPIXENT in subjects ≥40 kg.1

bA lower exposure DUPIXENT arm was studied in Part A (n=26) and Part B (n=36) but is not approved for the treatment of EoE.3

DUPIXENT ENROLLED CHILDREN WITH UNCONTROLLED EoE
DESPITE PPI USE1

Patient demographics and baseline characteristics3

-
DUPIXENT (n=32) 7.4 (2.8)
Placebo (n=29) 8.1 (2.4)
DUPIXENT (n=32) 25 (78.1)
Placebo (n=29) 21 (72.4)
DUPIXENT (n=32) 17 (53.1)
Placebo (n=29) 8 (27.6)
DUPIXENT (n=32) 27 (84.4)
Placebo (n=29) 24 (82.8)
DUPIXENT (n=32) 27 (84.4)
Placebo (n=29) 22 (75.9)
DUPIXENT (n=32) 97.7 (48.2)
Placebo (n=29) 82.2 (36.2)
DUPIXENT (n=32) 6.9 (2.6)
Placebo (n=29) 7.3 (2.6)
DUPIXENT (n=32) 50.8 (27.6)
Placebo (n=29) 51.4 (34.1)
DUPIXENT (n=32) 0.43 (0.39)
Placebo (n=29) 0.49 (0.36)
  • Patients using PPIs during screening were either to continue throughout the entire study or stop prior to baseline3
  • Unless used as rescue medications, systemic and/or swallowed TCS were prohibited during the treatment period3

Not actual patients.

EFFICACY

DEMONSTRATED GREATER HISTOLOGIC IMPROVEMENTS IN CHILDREN AS YOUNG AS 1 YEAR1,3

Histologic improvements were observed at Weeks 16 and 52 with DUPIXENT1,3

Histologic Remission1,3
(≤6 EOS/HPF peak esophageal
intraepithelial EOS count)

Histologic Response1,3
(<15 EOS/HPF peak esophageal
intraepithelial EOS count)

Results are descriptive in the extended active treatment period at Week 52. Definitive conclusions cannot be made due to limitations
associated with extended active treatment design, including lack of comparator arm and decreasing sample size.3

Peak Esophageal Intraepithelial Eosinophil Count
Used to confirm diagnosis and determine treatment response. Histologic data are reported as the percentage of patients achieving the defined EOS threshold.4

VISIBLE IMPROVEMENTS IN THE ESOPHAGUS WERE OBSERVED3

Improvements in EREFS total scores were observed at Weeks 16 and 52 with DUPIXENT3

Reduction in EREFS
total score3,c

Thresholds for clinically meaningful changes in EREFS scores have not been established. Results are descriptive in the extended active
treatment period at Week 52. Definitive conclusions cannot be made due to limitations associated with extended active treatment design,
including lack of comparator arm and decreasing sample size.3

cReductions indicate improvements in score.3

Endoscopic Reference Score (EREFS)
EREFS is a clinician-reported rating of the severity of 5 endoscopic features: edema, rings, exudates, furrows, and stricture.5

DECREASES IN SIGNS AND SYMPTOMS WERE REPORTED BY CAREGIVERS1,3,d

Decrease in the number of days with ≥1 sign or symptom of EoE via LSM change in PESQ‑C1,3,d

Definitive conclusions cannot be made. Numerical improvements were observed at Week 16 and maintained for 52 weeks. Results are descriptive at Week 52 due to limitations associated with extended active treatment design, including lack of comparator arm and decreasing sample size3

dBaseline PESQ-C was 0.43 (6.0 days) in the DUPIXENT arm and 0.49 (6.9 days) in the placebo arm. Days are out of a 14-day period.3

PESQ-C MEASURES THE PRESENCE OF SIGNS AND SYMPTOMS OF EoE IN CHILDREN3,6

Pediatric EoE Signs/Symptoms Questionnaire-Caregiver (PESQ-C) is a novel questionnaire designed with expert guidance to recognize 8 distinct signs and symptoms of EoE over a 14-day period by caregivers:

Stomach pain
Heartburn
Acid reflux
Regurgitation
Vomiting
Difficulty
swallowing
Food getting
stuck
Food refusal
  • Caregiver responses reflect what their child has told them, what they have directly observed, and/or what another caregiver has told them
  • Total score ranges from 0 to 1. For example, if the patient has 7 days of symptoms over the 14-day period, their total score is 0.50 (calculated by 7÷14)3,6

CHANGES IN BODY WEIGHT FOR AGE PERCENTILE WERE STUDIED3

Change in body weight for age percentile3,e

Results are descriptive. Definitive conclusions cannot be made due to the exploratory nature of the results at Week 16 and lack of comparator
arm and decreasing sample size at Week 52.3

eBody weight for age percentile, standardized by gender and age, is used to assess a child's weight compared to their peers.

SAFETY PROFILE

DEMONSTRATED SAFETY PROFILE IN CHILDREN AS YOUNG AS 1 YEAR1,3

Adverse events occurring in ≥5% of patients treated with DUPIXENT and greater than placebo through 16 weeks1,3

-
DUPIXENT
(n=32) | n (%)		 4 (13)
Placebo
(n=29) | n (%)		 1 (3)
DUPIXENT
(n=32) | n (%)		 3 (9)
Placebo
(n=29) | n (%)		 0
DUPIXENT
(n=32) | n (%)		 2 (6)
Placebo
(n=29) | n (%)		 1 (3)
DUPIXENT
(n=32) | n (%)		 2 (6)
Placebo
(n=29) | n (%)		 1 (3)
DUPIXENT
(n=32) | n (%)		 2 (6)
Placebo
(n=29) | n (%)		 1 (3)
DUPIXENT
(n=32) | n (%)		 2 (6)
Placebo
(n=29) | n (%)		 0

fAll cases were mild or moderate and did not lead to study discontinuation.3

The safety profile of DUPIXENT through Week 16 of the EoE KIDS clinical study was generally
similar to the safety profile in adult and pediatric patients 12 years of age and older with EoE.
In Part B, a helminth infection was reported in one DUPIXENT-treated subject.1

IMPORTANT ATTRIBUTES AND
CONSIDERATIONS FOR DUPIXENT1

NO BOXED WARNING

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

NO KNOWN DRUG-TO-DRUG INTERACTIONS

  • Not metabolized through the liver or excreted through the kidneys

DUPIXENT IS NOT AN IMMUNOSUPPRESSANT

NO REQUIREMENT FOR
INITIAL LAB
TESTING OR
ONGOING LAB MONITORING,

according to the Prescribing Information

SELECT IMPORTANT SAFETY
INFORMATION

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme, have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.

Not actual
patients.

DOSING

WEIGHT-BASED DOSING
and option to administer
at home or in office1

DUPIXENT is administered by subcutaneous injection and is intended for use under the guidance of a healthcare provider.1

  • A caregiver or patient 12 years of age and older may inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe or pre-filled pen1
  • In children 12 years of age and older, it is recommended that DUPIXENT be given by or under the supervision of an adult1
  • In children 1 year to less than 12 years of age, DUPIXENT should be given by a caregiver1
  • Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use, according to the Instructions for Use1
  • Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT1

Weight-tiered dosage regimen1

1+ YEAR OF AGE
No loading dose

15 to <30 kg
Every 2 weeks
200 mgg 1 pre-filled pen or syringe
30 to <40 kg
Every 2 weeks
300 mgh 1 pre-filled pen or syringe
≥40 kgi
Every week
300 mgh 1 pre-filled pen or syringe

g200 mg=1.14 mL solution.1

h300 mg=2 mL solution.1

iThe recommended dosage of 300 mg QW for pediatric subjects 1 to 11 years of age weighing ≥40 kg is based on modeled pharmacokinetic data to
provide comparable exposures to the 300 mg QW dosage in adult and pediatric subjects 12 years of age and older weighing ≥40 kg with EoE.1

Administration options1

Important administration instructions1

  • Patients and/or caregivers should read the Instructions for Use prior to injecting
  • Instruct patients and/or caregivers to administer the subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel
  • The upper arm can also be used if a caregiver administers the injection
  • It is important to rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred
  • After administration, advise patients to follow sharps disposal recommendations

See the Instructions for Use for more detailed instructions on the preparation and administration of DUPIXENT

Pre-filled Pen

Instructions for Use - 200 mg Instructions for Use - 300 mg

Pre-filled Syringe

Instructions for Use - 200 mg Instructions for Use - 300 mg

Supplemental Injection Training

VIEW PATIENT VIDEOS

 

Missed dose information1

  • If a weekly dose is missed, administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose
  • If an every other week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient’s original schedule. If the missed dose is not administered within 7 days, wait until the next dose on the original schedule

 

EOS, eosinophil; EOS/HPF, eosinophils per high-power field; EREFS, endoscopic reference score; LSM, least squares mean; PESQ-C, Pediatric EoE Signs/Symptoms Questionnaire-Caregiver; PPI, proton pump inhibitor; QW, once weekly; Q2W, once every 2 weeks; TCS, topical corticosteroids.

 

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