Table 1.
Patient baseline demographics and clinical characteristics
| Characteristic | FAS (n = 304) | IGA > 1 subgroup (n = 227) | ||||
|---|---|---|---|---|---|---|
| Dupilumab 200 mg q2w + TCS (n = 59) | Dupilumab 300 mg q4w + TCS (n = 122) | Placebo + TCS (n = 123) | Dupilumab 200 mg q2w + TCS (n = 36) | Dupilumab 300 mg q4w + TCS (n = 82) | Placebo + TCS (n = 109) | |
| Age (years), mean (SD) | 9.5 (1.36) | 8.5 (1.74) | 8.3 (1.76) | 9.7 (1.33) | 8.5 (1.81) | 8.4 (1.76) |
| Male, n (%) | 33 (55.9) | 57 (46.7) | 61 (49.6) | 22 (61.1) | 38 (46.3) | 52 (47.7) |
| Weight (kg), mean (SD) | 40.2 (9.99) | 31.0 (9.40) | 31.5 (10.82) | 41.5 (10.97) | 31.4 (10.43) | 31.7 (10.89) |
| BMI, mean (SD), kg/m2 | 20.2 (4.03) | 17.6 (2.93) | 17.9 (3.90) | 20.7 (4.54) | 17.7 (3.21) | 18.0 (3.90) |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 9 (15.3) | 16 (13.1) | 13 (10.6) | 7 (19.4) | 8 (9.8) | 12 (11.0) |
| Race, n (%) | ||||||
| White | 45 (76.3) | 89 (73.0) | 77 (62.6) | 27 (75.0) | 59 (72.0) | 65 (59.6) |
| Black or African American | 8 (13.6) | 19 (15.6) | 23 (18.7) | 6 (16.7) | 13 (15.9) | 21 (19.3) |
| Asian | 4 (6.8) | 5 (4.1) | 13 (10.6) | 1 (2.8) | 3 (3.7) | 13 (11.9) |
| Other | 1 (1.7) | 8 (6.6) | 9 (7.3) | 1 (2.8) | 7 (8.5) | 9 (8.3) |
| Not reported/missing | 1 (1.7) | 1 (0.8) | 1 (0.8) | 1 (2.8) | 0 | 1 (0.9) |
| Duration of AD (years), mean (SD) | 8.1 (2.25) | 7.4 (2.44) | 7.2 (2.15) | 8.4 (2.25) | 7.4 (2.57) | 7.3 (2.04) |
| Disease severity and QoL, mean (SD) unless otherwise noted | ||||||
| IGA score 4, n (%) | 59 (100.0) | 121 (99.2) | 123 (100.0) | 36 (100.0) | 81 (98.8) | 109 (100) |
| EASI total score (0–72) | 37.1 (11.77) | 37.4 (12.45) | 39.0 (12.01) | 38.6 (13.30) | 39.4 (12.95) | 39.8 (12.01) |
| Peak pruritus NRS score, mean (SD) (0–10) | 7.6 (1.49) | 7.8 (1.58) | 7.7 (1.54) | 7.5 (1.56) | 8.0 (1.56) | 7.8 (1.55) |
| BSA affected by AD (%) | 53.9 (20.17) | 54.8 (21.58) | 60.2 (21.46) | 56.9 (21.46) | 58.1 (22.02) | 61.1 (21.99) |
| SCORAD total score (0–103) | 71.2 (11.29) | 75.6 (11.71) | 72.9 (12.01) | 72.6 (11.89) | 77.5 (11.36) | 73.7 (12.22) |
| GISS (0–12) | 10.3 (1.34) | 10.3 (1.38) | 10.2 (1.54) | 10.3 (1.31) | 10.4 (1.41) | 10.3 (1.52) |
| CDLQI (0–30) | 13.0 (6.25) | 16.2 (7.85) | 14.6 (7.41) | 14.1 (6.40) | 16.9 (7.78) | 14.8 (7.45) |
| POEM score (0–28) | 19.9 (5.33) | 21.3 (5.51) | 20.7 (5.48) | 19.9 (5.48) | 21.7 (5.50) | 21.2 (5.32) |
| History of atopic comorbidities, n/N1 (%) | ||||||
| Patients with ≥ 1 concurrent allergic condition, excluding AD | 54/58 (93.1) | 107/120 (89.2) | 112/121 (92.6) | 32/35 (91.4) | 72/80 (90.0) | 100/107 (93.5) |
| Allergic conjunctivitis (keratoconjunctivitis) | 6/58 (10.3) | 14/120 (11.7) | 16/121 (13.2) | 3/35 (8.6) | 8/80 (10.0) | 16/107 (15.0) |
| Allergic rhinitis | 42/58 (72.4) | 73/120 (60.8) | 73/121 (60.3) | 26/35 (74.3) | 49/80 (61.3) | 67/107 (62.6) |
| Asthma | 29/58 (50.0) | 55/120 (45.8) | 55/121 (45.5) | 16/35 (45.7) | 34/80 (42.5) | 50/107 (46.7) |
| Chronic rhinosinusitis | 1/58 (1.7) | 5/120 (4.2) | 4/121 (3.3) | 1/35 (2.9) | 3/80 (3.8) | 4/107 (3.7) |
| Eosinophilic esophagitis | 0 | 1/120 (0.8) | 0 | 0 | 0 | 0 |
| Food allergy | 35/58 (60.3) | 75/120 (62.5) | 84/121 (69.4) | 23/35 (65.7) | 53/80 (66.3) | 76/107 (71.0) |
| Hives | 7/58 (12.1) | 14/120 (11.7) | 8/121 (6.6) | 5/35 (14.3) | 11/80 (13.8) | 7/107 (6.5) |
| Nasal polyps | 2/58 (3.4) | 0 | 0 | 1/35 (2.9) | 0 | 0 |
| Other allergies | 33/58 (56.9) | 67/120 (55.8) | 82/121 (67.8) | 22/35 (62.9) | 44/80 (55.0) | 75/107 (70.1) |
| Patients receiving prior systemic medications for AD, n/N1 (%) | 16/58 (27.6) | 42/120 (35.0) | 36/121 (29.8) | 13/35 (37.1) | 31/80 (38.8) | 35/107 (32.7) |
| Patients receiving prior | ||||||
| Systemic corticosteroids | 11/58 (19.0) | 25/120 (20.8) | 17/121 (14.0) | 10/35 (28.6) | 16/80 (20.0) | 16/107 (15.0) |
| Systemic nonsteroidal immunosuppressants | 6/58 (10.3) | 23/120 (19.2) | 22/121 (18.2) | 4/35 (11.4) | 19/80 (23.8) | 22/107 (20.6) |
| Azathioprine | 0 | 2/120 (1.7) | 0 | 0 | 2/80 (2.5) | 0 |
| Cyclosporine | 4/58 (6.9) | 17/120 (14.2) | 12/121 (9.9) | 4/35 (11.4) | 14/80 (17.5) | 12/107 (11.2) |
| Methotrexate | 1/58 (1.7) | 7/120 (5.8) | 11/121 (9.1) | 0 | 6/80 (7.5) | 11/107 (10.3) |
| Mycophenolate | 1/58 (1.7) | 2/120 (1.7) | 2/121 (1.7) | 0 | 2/80 (2.5) | 2/107 (1.9) |
AD atopic dermatitis, BMI body mass index, BSA body surface area, CDLQI Children’s Dermatology Life Quality Index, EASI Eczema Area and Severity Index, FAS full analysis set, GISS Global Individual Signs Score, IGA Investigator’s Global Assessment, POEM Patient-Oriented Eczema Measure, q2w every 2 weeks, q4w every 4 weeks, QoL quality of life, SCORAD SCORing Atopic Dermatitis, SD standard deviation, TCS topical corticosteroids