Histologic Results

DUPIXENT DEMONSTRATED GREATER HISTOLOGIC IMPROVEMENTS IN CHILDREN AS YOUNG AS 1 YEAR1,2

Histologic improvements were observed at Week 16 and Week 521,2

Histologic Remission1,2
(≤6 EOS/HPF peak esophageal
intraepithelial EOS count)

Histologic Response1,2
(<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.2

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

EOS, eosinophil: EOS/HPF, eosinophils per high-power field.

Endoscopic Results

VISIBLE IMPROVEMENTS IN THE ESOPHAGUS WERE OBSERVED1,2

Improvements in EREFS total scores were observed at Weeks 16 and 52 with DUPIXENT1,2

Reduction in EREFS
total scored

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.2

dReductions indicate improvements in score.2

Endoscopic Reference Score (EREFS)
EREFS is a clinician-reported rating of the severity of 5 endoscopic features:
edema, rings, exudates, furrows, and strictures.6

LSM, least squares mean.

Clinical Results

DECREASES IN SIGNS AND SYMPTOMS WERE REPORTED BY CAREGIVERS1,2

Decrease in the number of days with ≥1 sign or symptom of EoE via LSM change in PESQ-C1,2,e

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 size.3

eBaseline number of days with EoE symptoms out of a 14-day period was 6.0 days in the DUPIXENT arm, 6.9 days in the placebo arm, and 7.8 days in the placebo to DUPIXENT arm.3

PEDIATRIC EoE SIGNS/SYMPTOMS QUESTIONNAIRE-CAREGIVER (PESQ-C)

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 caregivers3,6:

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 0.5
    (calculated by 7 ÷ 14).3,6

CHANGES IN BODY WEIGHT FOR AGE PERCENTILE WERE STUDIED2

Change in body weight for age percentile2,a

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

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

LSM, least squares mean.

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