Clinical Program

Clinical program expanded to include a study in children 6-11 years of age with severe atopic dermatitis

AD-1526

A multicenter, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety profiles of DUPIXENT® with concomitant TCS in 367 pediatric AD patients (6 to 11 years old) for 16 weeks. Enrollment was stratified by baseline weight (<30 kg; ≥30 kg).^1†

The recommended dose of DUPIXENT® for children aged 6-11 years old weighing 15 to less than 30 kg is an initial dose of 600 mg followed by subsequent doses of 300 mg Q4W.

For children weighing 30 to less than 60 kg, the recommended initial dose is 400 mg, followed by subsequent doses of 200 mg Q2W. For more information on recommended dosing, please consult the DUPIXENT® Product Monograph.¹

Patient demographics¹

8.5 years - mean age

29.8 kg - median weight

50.1% - female

69.2% - white

7.6% - Asian

16.9% - black

91.7% - had at least one co-morbid allergic condition

60.2% - allergic rhinitis

64.4% - food allergy

62.7% - other allergies

46.7% - asthma

Disease severity at baseline¹

57.6% mean BSA involvement

16.9% received prior systemic non-steroidal immunosuppressant

37.9 mean EASI score

7.8/10 weekly averaged daily worst itch score

73.6 mean SCORAD score

20.9 POEM score

15.1 mean CDLQI

AD-1434

A 52-week open-label extension trial including 368 pediatric patients (6 to 11 years of age) investigating the efficacy of DUPIXENT® + TCS in pediatric patients who had participated in a prior atopic dermatitis study¹

† Patients in the DUPIXENT® Q4W + TCS group with baseline weight of <30 kg received an initial dose of 600 mg on Day 1, followed by 300 mg Q4W from Week 4 to Week 12, and patients with baseline weight of ≥30 kg received an initial dose of 400 mg on Day 1, followed by 200 mg Q2W from Week 2 to Week 14. Patients were permitted to receive rescue treatment at the discretion of the investigator. Patients who received rescue treatment were considered non-responders¹

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MAT-CA-2300298
Last updated: 06/2023

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