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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 weeks1,2
PEDIATRIC study designa,b
- 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)1,2
- 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)1,2
- All enrolled subjects were required to have uncontrolled EoE as defined by ≥15 intraepithelial EOS/HPF despite 8-week course of a high-dose PPI and a history of EoE signs and symptoms1,2
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.2
| DUPIXENT (n=32) | Placebo (n=29) | |
|---|---|---|
| Mean age, years (SD) | 7.4 (2.8) | 8.1 (2.4) |
| Male, n (%) | 25 (78.1) | 21 (72.4) |
| PPI use at randomization, n (%) | 17 (53.1) | 8 (27.6) |
| Prior swallowed topical steroid use, n (%) | 27 (84.4) | 24 (82.8) |
| Food elimination diet at screening, n (%) | 27 (84.4) | 22 (75.9) |
| Mean peak intraepithelial EOS count in 3 regions (SD) | 97.7 (48.2) | 82.2 (36.2) |
| Mean EREFS total score (range 0-18) (SD) | 6.9 (2.6) | 7.3 (2.6) |
| Mean weight for age percentile (SD) | 50.8 (27.6) | 51.4 (34.1) |
| Mean baseline proportion of days with ≥1 EoE signs for PESQ-C; range 0-1 (SD) | 0.43 (0.39) ~6.0 days |
0.49 (0.36) ~6.9 days |
PEDIATRIC PATIENTS
|
|---|
| 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) ~6.0 days |
| Placebo (n=29) | 0.49 (0.36) ~6.9 days |
- Patients using PPIs during screening were either to continue throughout the entire study or stop prior to baseline2
- Unless used as rescue medications, systemic and/or swallowed TCS were prohibited during the treatment period2
EOS, eosinophils; EOS/HPF, eosinophils per high-power field; EREFS, endoscopic reference score; PESQ-C, Pediatric EoE Signs/Symptoms Questionnaire-Caregiver; PPI, proton pump inhibitor; QW, once weekly; Q2W, once every 2 weeks; TCS, topical corticosteroid.
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