Table 1.
Baseline demographics and clinical characteristics
| Placebo + TCS (N = 62) | Dupilumab 200/300 mg q4w + TCS (N = 63) | |
|---|---|---|
| Baseline demographics | ||
| Age, mean (SD), years | 3.9 (1.2) | 3.9 (1.3) |
| Age group (years), n (%) | ||
| 6 months to < 2 years | 3 (4.8) | 6 (9.5) |
| ≥ 2 years to 5 years | 59 (95.2) | 57 (90.5) |
| Sex, male (%) | 42 (67.7) | 37 (58.7) |
| Race, n (%) | ||
| White | 38 (61.3) | 43 (68.3) |
| Black/African American | 15 (24.2) | 12 (19.0) |
| Other | 9 (14.5) | 8 (12.7) |
| Ethnicity, n (%) | ||
| Not Hispanic or Latino | 56 (90.3) | 52 (82.5) |
| Hispanic or Latino | 6 (9.7) | 11 (17.5) |
| Height (cm), mean (SD)a | 101.2 (10.2) | 99.8 (12.7) |
| Weight (kg), mean (SD) | 17.0 (3.7) | 17.2 (4.5) |
| Weight group (kg), n (%) | ||
| 5 to < 15 | 18 (29.0) | 18 (28.6) |
| 15 to < 30 | 44 (71.0) | 45 (71.4) |
| BMI, mean (SD)b | 16.3 (2.0) | 17.2 (6.3) |
| Country, n (%) | ||
| Germany | 2 (3.2) | 4 (6.3) |
| Poland | 15 (24.2) | 15 (23.8) |
| UK | 5 (8.1) | 4 (6.3) |
| USA | 40 (64.5) | 40 (63.5) |
| Clinical characteristics | ||
| Age at disease onset, n (%) | ||
| < 6 months | 44 (71.0) | 36 (57.1) |
| ≥ 6 months | 18 (29.0) | 27 (42.9) |
| Duration of AD, mean (SD; range), years | 3.5 (1.3; 0–6) | 3.3 (1.4; 0–6) |
| Duration of AD, n (%) | ||
| < 3 years | 22 (35.5) | 23 (36.5) |
| ≥ 3 years | 40 (64.5) | 40 (63.5) |
| EASI, mean (SD; range) | 35.4 (12.0; 12–72) | 38.8 (13.7; 18–72) |
| SCORAD, mean (SD; range) | 74.8 (10.8; 50–98) | 76.7 (11.5; 50–98) |
| BSA of AD, mean (SD; range) | 58.9 (21.4; 14–100) | 63.1 (21.1; 19–100) |
| Weekly average of daily worst scratch/itch score, mean (SD; range) | 7.6 (1.6; 2–10) | 7.6 (1.4; 4–10) |
| Caregiver Global Impression of Disease, n (%) | ||
| Moderate | 9 (14.5) | 7 (11.1) |
| Severe | 31 (50.0) | 31 (49.2) |
| Very severe | 22 (35.5) | 25 (39.7) |
| POEM, mean (SD; range) | 23.4 (4.0; 9–28) | 23.7 (3.9; 14–28) |
| CDLQI, mean (SD; range)*c | 17.8 (6.4; 5–28) | 17.5 (5.5; 7–29) |
| IDQOL, mean (SD; range)*d | 17.4 (5.4; 5–28) | 18.4 (5.1; 10–29) |
| GISS, mean (SD; range) | 10.1 (1.5; 7–12) | 10.3 (1.5; 7–12) |
| DFI, mean (SD; range) | 17.4 (7.5; 3–29) | 17.6 (6.0; 5–30) |
| Weekly average of daily skin pain NRS score, mean (SD; range)e | 7.1 (1.9; 2–10) | 6.9 (1.9; 1–10) |
| Weekly average of daily patient's sleep quality score, mean (SD; range)f | 4.7 (2.0; 0–9) | 4.9 (2.0; 0–9) |
| Weekly average of daily caregiver's sleep quality score, mean (SD; range)g | 4.8 (2.0; 0–9) | 5.1 (2.0; 0–9) |
| Patients with ≥ 1 concurrent allergic condition, n (%) | ||
| Food allergy (self-reported) | 46 (74.2) | 42 (66.7) |
| Allergic rhinitis | 31 (50.0) | 25 (39.7) |
| Asthma | 18 (29.0) | 14 (22.2) |
| Hives | 16 (25.8) | 15 (23.8) |
| Allergic conjunctivitis | 4 (6.5) | 4 (6.4) |
| Chronic rhinosinusitis | 2 (3.2) | 0 |
| Eosinophilic esophagitis | 2 (3.2) | 2 (3.2) |
| Nasal polyps | 0 | 0 |
| Other allergies | 35 (56.5) | 34 (54.0) |
| Prior systemic medications for AD, n (%) | 17 (27.4) | 20 (31.8) |
| Prior systemic corticosteroids | 10 (16.1) | 13 (20.6) |
| Prior systemic non-steroidal immunosuppressants | 10 (16.1) | 12 (19.1) |
| Cyclosporine | 7 (11.3) | 9 (14.3) |
| Methotrexate | 5 (8.1) | 5 (7.9) |
| Mycophenolate | 2 (3.2) | 2 (3.2) |
| Azathioprine | 1 (1.6) | 1 (1.6) |
AD atopic dermatitis, BMI body mass index, BSA body surface area, CDLQI Child Dermatology Life Quality Index, DFI Dermatitis Family Impact, EASI Eczema Area and Severity Index, EASI-75 75% decrease in EASI, GISS Global Individual Signs Score, IDQOL Infants' Dermatitis Quality of Life Index, IGA Investigator’s Global Assessment, LS least squares, NRS Numerical Rating Scale, POEM Patient-Oriented Eczema Measure, q4w every 4 weeks, SCORAD SCORing Atopic Dermatitis, SD standard deviation, TEAE treatment-emergent adverse event, TCS topical corticosteroids
*IDQOL for patients aged < 4 years; CDLQI for patients aged ≥ 4 years, aPlacebo group n = 61, dupilumab group n = 63. bPlacebo group n = 61, dupilumab group n = 63. cPlacebo group n = 32, dupilumab group n = 38. dPlacebo group n = 30, dupilumab group n = 25. ePlacebo group n = 61, dupilumab group n = 62. fPlacebo group n = 62, dupilumab group n = 62. gPlacebo group n = 62, dupilumab group n = 62