Table 2.
Efficacy outcomes at week 16
| 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) | |
| IGA 0/1, n (%) |
23 (39.0) p = 0.0002 |
40 (32.8) p < 0.0001 |
14 (11.4) | N/A | N/A | N/A |
| EASI-50, n (%) |
51 (86.4) p < 0.0001 |
111 (91.0) p < 0.0001 |
53 (43.1) |
28 (77.8) p = 0.0002 |
71 (86.6) p < 0.0001 |
39 (35.8) |
| EASI-75, n (%) |
44 (74.6) p < 0.0001 |
85 (69.7) p < 0.0001 |
33 (26.8) |
21 (58.3) p = 0.0001 |
45 (54.9) p < 0.0001 |
20 (18.3) |
| EASI LS mean percent change from baseline (SE) |
− 80.4 (3.61) p < 0.0001 |
− 82.1 (2.37) p < 0.0001 |
− 48.6 (2.46) |
− 71.4 (4.78) p < 0.0001 |
− 75.7 (3.03) p < 0.0001 |
− 42.5 (2.76) |
| Peak Pruritus NRS score LS mean percent change from baseline (SE) |
− 58.2 (4.01) p < 0.0001 |
− 54.6 (2.89) p < 0.0001 |
− 25.9 (2.90) |
− 48.4 (4.96) p < 0.0001 |
− 50.0 (3.45) p < 0.0001 |
− 23.2 (3.11) |
| Peak Pruritus NRS ≥ 3-point improvement from baseline, n/N (%) |
38/57 (66.7) p < 0.0001 |
73/121 (60.3) p < 0.0001 |
26/123 (21.1) |
19/34 (55.9) p = 0.0008 |
45/81 (55.6) p < 0.0001 |
19/109 (17.4) |
| Peak Pruritus NRS ≥ 4-point improvement from baseline, n/N (%) |
35/57 (61.4) p < 0.0001 |
61/120 (50.8) p < 0.0001 |
15/122 (12.3) |
17/34 (50.0) p < 0.0001 |
36/80 (45.0) p < 0.0001 |
9/108 (8.3) |
| SCORAD-50, n (%) |
44 (74.6) p < 0.0001 |
86 (70.5) p < 0.0001 |
28 (22.8) |
21 (58.3) p < 0.0001 |
46 (56.1) p < 0.0001 |
15 (13.8) |
| SCORAD Sleep VAS LS mean change from baseline (SE) |
− 4.56 (0.384) p < 0.0001 |
− 4.19 (0.245) p < 0.0001 |
− 1.96 (0.260) |
− 4.47 (0.502) p < 0.0001 |
− 4.10 (0.317) p < 0.0001 |
− 1.66 (0.302) |
| GISS LS mean percent change from baseline (SE) |
− 57.7 (3.17) p < 0.0001 |
− 57.0 (2.26) p < 0.0001 |
− 29.1 (2.36) |
− 46.2 (3.60) p < 0.0001 |
− 48.2 (2.50) p < 0.0001 |
− 24.1 (2.33) |
| POEM ≥ 6-point improvement from baseline, n/N (%) |
46/58 (79.3) p < 0.0001 |
98/120 (81.7) p < 0.0001 |
39/122 (32.0) |
23/35 (65.7) p = 0.0002 |
60/81 (74.1) p < 0.0001 |
29/108 (26.9) |
| CDLQI ≥ 6-point improvement from baseline, n/N (%) |
42/52 (80.8) p < 0.0001 |
85/110 (77.3) p < 0.0001 |
47/111 (42.3) |
27/33 (81.8) p < 0.0001 |
54/74 (73.0) p < 0.0001 |
40/98 (40.8) |
| PGID “no” or “mild” symptoms, n (%) |
41 (69.5) p < 0.0001 |
80 (65.6) p < 0.0001 |
21 (17.1) |
20 (55.6) p < 0.0001 |
48 (58.5) p < 0.0001 |
14 (12.8) |
| PGIC “much better,” n (%) |
47 (79.7) p < 0.0001 |
86 (70.5) p < 0.0001 |
33 (26.8) |
25 (69.4) p < 0.0001 |
51 (62.2) p < 0.0001 |
23 (21.1) |
| Use of ≥ 1 rescue medication, n/N (%) | 2/59 (3.4) | 3/120 (2.5) | 23/120 (19.2) | 2/36 (5.6) | 3/80 (3.8) | 23/106 (21.7) |
| Use of ≥ 1 systemic rescue medication, n/N (%) | 1/59 (1.7) | 0 | 7/120 (5.8) | 1/36 (2.8) | 0 | 7/106 (6.6) |
CDLQI Children’s Dermatology Life Quality Index, EASI Eczema Area and Severity Index, EASI-50 improvement from baseline of at least 50% in EASI, EASI-75 improvement from baseline of at least 75% in EASI, FAS full analysis set, GISS Global Individual Signs Score, IGA Investigator’s Global Assessment, LS least squares, N/A not applicable, NRS numerical rating scale, PGIC Patient Global Impression of Change, PGID Patient Global Impression of Disease, POEM Patient-Oriented Eczema Measure, q2w every 2 weeks, q4w every 4 weeks, SCORAD SCORing Atopic Dermatitis, SCORAD-50 SCORing Atopic Dermatitis total score, SE standard error, TCS topical corticosteroids, VAS visual analog scale