Table 2.
Efficacy outcomes at week 16
| Placebo + TCS (N = 62) | Dupilumab 200/300 mg q4w + TCS (N = 63) | ∆ vs. placebo (95% CI) | P value vs. placebo | |
|---|---|---|---|---|
| Patients with IGA ≤ 1 (score range 0–4), n (%) | 1 (1.6) | 9 (14.3) | 12.7 (3.4, 21.9) | 0.0085 |
| Patients with IGA ≤ 2 (score range 0–4), n (%) | 5 (8.2) | 27 (42.9) | 34.7 (20.6, 48.7) | < 0.0001 |
| Patients with EASI-75 (score range 0–72), n (%) | 4 (6.6) | 29 (46.0) | 39.5 (25.7, 53.3) | < 0.0001 |
| Percent change from baseline in EASI, LS mean (SE) | − 20.1 (3.84) | − 63.5 (3.81) | − 43.5 (− 53.66, − 33.32) | < 0.0001 |
| Percent change from baseline in Worst Scratch/Itch NRS (score range 0–10), LS mean (SE) | − 4.7 (5.07) | − 44.9 (4.99) | − 40.2 (− 53.41, − 27.00) | < 0.0001 |
| Patients with improvement of weekly average of daily Worst Scratch/Itch NRS ≥ 4, n (%) | 5 (8.8) | 27 (42.3) | 33.5 (19.0, 48.0) | 0.0002 |
| Patients with improvement of weekly average of daily Worst Scratch/Itch NRS ≥ 3, n (%) | 6 (9.5) | 29 (45.4) | 35.9 (21.0, 50.8) | < 0.0001 |
| Patients with EASI-50, n (%) | 12 (19.2) | 38 (60.3) | 41.1 (25.3, 56.9) | < 0.0001 |
| Patients with EASI-90, n (%) | 0 (0) | 10 (15.9) | 15.5 (6.2, 24.8) | 0.0043 |
| Change from baseline in percent BSA affected by AD, LS mean (SE) | − 7.6 (3.0) | − 29.4 (2.9) | − 21.8 (− 30.0, − 13.6) | < 0.0001 |
| Change from baseline in POEM (scale range 0–28), LS mean (SE) | − 2.5 (1.0) | − 10.6 (0.9) | − 8.1 (− 10.7, − 5.5) | < 0.0001 |
| Percent change from baseline in SCORAD (score range 0 − 103), LS mean (SE) | − 11.1 (3.5) | − 44.6 (3.4) | − 33.4 (− 43.0, − 23.9) | < 0.0001 |
| Change from baseline in patient’s sleep quality NRS* (0–10), LS mean (SE) | 0.2 (0.2) | 1.7 (0.3) | 1.5 (0.8, 2.2) | < 0.0001 |
| Change from baseline in patient’s skin pain NRS (range 0–10), LS mean (SE) | − 0.3 (0.3) | − 3.4 (0.3) | − 3.1 (− 3.9, − 2.3) | < 0.0001 |
| Change from baseline in DFI (0–30), LS mean (SE) | − 2.1 (0.8) | − 9.1 (0.8) | − 7.1 (− 9.4, − 4.8) | < 0.0001 |
| Change from baseline in CDLQI (0–30), LS mean (SE)a | − 2.6 (1.2) | − 9.1 (1.1) | − 6.6 (− 9.7, − 3.4) | < 0.0001 |
| Change from baseline in IDQOL (0–30), LS mean (SE)b | − 0.6 (1.1) | − 9.1(1.3) | − 8.5 (− 11.8, − 5.1) | < 0.0001 |
BSA body surface area, CDLQI Children’s Dermatology Life Quality Index, DFI Dermatitis Family Impact, EASI Eczema Area and Severity Index, EASI-75 75% decrease in EASI, 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, SE standard error, TEAE treatment-emergent adverse event, TCS topical corticosteroids
*Increase in score means improvement. aPlacebo group n = 32, dupilumab group n = 37. bPlacebo group n = 30, dupilumab group n = 26