Table 1.
Baseline demographics and clinical characteristics [19]
| Placebo + TCS (N = 79)a | Dupilumab 200/300 mg q4w + TCS (N = 83) | |
|---|---|---|
| Age, years | 3.8 (2.9,4.8; 0.6–5.9) | 4.2 (3.1,4.8; 0.8–5.8) |
| Age at disease onset, months | ||
| < 6 | 57 (72%) | 50 (60%) |
| ≥ 6 | 22 (28%) | 33 (40%) |
| Age group | ||
| 6 months to < 2 years | 5 (6%) | 6 (7%) |
| 2 years to < 4 years | 36 (46%) | 30 (36%) |
| 4 years to < 6 years | 38 (48%) | 47 (57%) |
| Sex (male) | 55 (70%) | 44 (53%) |
| Race | ||
| White | 53 (67%) | 58 (70%) |
| Black or African American | 16 (20%) | 14 (17%) |
| Asian | 4 (5%) | 6 (7%) |
| Native Hawaiian/other Pacific Islander | 1 (1%) | 0 |
| Not reported | 1 (1%) | 2 (2%) |
| Other | 4 (5%) | 3 (4%) |
| Bodyweight group, kg | ||
| ≥ 5 to < 15 | 25 (32%) | 26 (31%) |
| ≥ 15 to < 30 | 54 (68%) | 57 (69%) |
| BMI, kg/m2 | 16.2 (1.9) | 17.0 (5.6) |
| Duration of ADb, years | 3.4 (1.3) | 3.4 (1.3) |
| Patients with IGA score (range 0–4) | ||
| 3 | 17 (22%) | 20 (24%) |
| 4 | 62 (78%) | 63 (76%) |
| EASI score (range 0–72) | 33.1 (12.2) | 35.1 (13.9) |
| Worst scratch and itch NRS score (range 0–10)c | 7.6 (1.5) | 7.5 (1.3) |
| Proportion BSA involvement | 57.4% (20.9) | 59.3% (22.5) |
| Patients with ≥ 1 concurrent atopic or allergic conditiond | 65 (83%) | 66 (80%) |
| Food allergy | 55 (71%) | 55 (66%) |
| Allergic rhinitis | 36 (46%) | 35 (42%) |
| Asthma | 21 (27%) | 20 (24%) |
| Urticaria | 15 (19%) | 14 (17%) |
| Allergic conjunctivitis | 3 (4%) | 4 (5%) |
| Other allergiese | 42 (54%) | 43 (52%) |
Data are n (%), median (interquartile range; range), or mean (standard deviation). Higher score indicates worse disease/larger impact
AD atopic dermatitis, BMI body mass index, BSA body surface area, EASI Eczema Area and Severity Index, IGA Investigator’s Global Assessment, NRS numerical rating scale, TCS topical corticosteroids, q4w every 4 weeks
aOne patient was randomized in error and did not receive study treatment and was therefore not included in the safety analysis
bMean duration of AD for patients aged 6 months to younger than 2 years (n = 11) was 0.8 (standard deviation 0.4)
cWeekly mean of daily measure
dAssessed in the safety analysis set (dupilumab + TCS n = 83, placebo + TCS n = 78)
eRefers to allergies to plants, animals, dust, mites, and medication
Reprinted from The Lancet, Vol. 400, Paller AS et al., Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial. Pages 908–19, 2022, with permission from Elsevier