Table 3.
Efficacy outcomes at week 16
| Age ≥ 60 years | Age < 60 years | |||||
|---|---|---|---|---|---|---|
| Placebo qw (n = 56) | Dupilumab 300 mg q2w (n = 54) |
Dupilumab 300 mg qw (n = 73) |
Placebo qw (n = 827) | Dupilumab 300 mg q2w (n = 616) |
Dupilumab 300 mg qw (n = 818) |
|
| Patients achieving IGA 0/1 and ≥ 2-point improvement from baseline, n (%) | 4 (7.1) |
24 (44.4) < 0.0001 |
29 (39.7) < 0.0001 |
100 (12.1) |
233 (37.8) < 0.0001 |
325 (39.7) < 0.0001 |
| Patients achieving EASI-75, n (%) | 8 (14.3) |
34 (63.0) < 0.0001 |
45 (61.6) < 0.0001 |
183 (22.1) |
340 (55.2) < 0.0001 |
494 (60.4) < 0.0001 |
| EASI, LS mean change (SE) | − 10.15 (1.742) |
− 24.77 (1.805) < 0.0001 |
− 23.89 (1.530) < 0.0001 |
− 10.09 (0.436) |
− 23.47 (0.495) < 0.0001 |
− 23.27 (0.436) < 0.0001 |
| Peak Pruritus NRS, LS mean change (SE) | − 1.65 (0.337) |
− 3.80 (0.345) < 0.0001 |
− 3.96 (0.292) < 0.0001 |
− 1.53 (0.079) |
− 3.64 (0.091) < 0.0001 |
− 3.64 (0.080) < 0.0001 |
| Patients achieving ≥ 4-point improvement in Peak Pruritus NRS, n/N1 (%) | 12/47 (25.5) |
23/52 (44.2) 0.0096 |
38/65 (58.5) 0.0003 |
128/776 (16.5) |
262/582 (45.0) < 0.0001 |
353/753 (46.9) < 0.0001 |
| Patients achieving ≥ 4-point improvement in DLQI, n/N1 (%) | 19/50 (38.0) |
43/50 (86.0) < 0.0001 |
50/70 (71.4) 0.0004 |
382/783 (48.8) |
465/579 (80.3) < 0.0001 |
623/783 (79.6) < 0.0001 |
| Patients achieving ≥ 4-point improvement in POEM, n/N1 (%) | 24/56 (42.9) |
42/53 (79.2) < 0.0001 |
60/73 (82.2) < 0.0001 |
343/820 (41.8) |
495/614 (80.6) < 0.0001 |
656/815 (80.5) < 0.0001 |
| SCORAD, LS mean change (SE) | − 14.83 (2.560) |
− 42.21 (2.668) < 0.0001 |
− 40.35 (2.232) < 0.0001 |
− 14.84 (0.686) |
− 37.78 (0.782) < 0.0001 |
− 37.14 (0.687) < 0.0001 |
| SCORAD Sleep VAS, LS mean change (SE) | − 1.28 (0.354) |
− 3.80 (0.369) < 0.0001 |
− 3.74 (0.306) < 0.0001 |
− 1.16 (0.095) |
− 3.45 (0.108) < 0.0001 |
− 3.39 (0.095) < 0.0001 |
| EQ-5D pain/discomfort, LS mean change (SE) | − 0.15 (0.071) |
− 0.54 (0.073) 0.0001 |
− 0.56 (0.062) < 0.0001 |
− 0.21 (0.020) |
− 0.57 (0.022) < 0.0001 |
− 0.57 (0.020) < 0.0001 |
| Total IgE (IU/mL), LS mean change (SE) | 208.60 (429.161) |
− 1833.37 (400.539) 0.0005 |
− 1655.52 (340.953) 0.0006 |
213.63 (121.010) |
− 2635.17 (127.014) < 0.0001 |
− 2375.93 (112.642) < 0.0001 |
| Total IgE (IU/mL), median (Q1–Q3) |
2161.5 (273.0–8445.0) |
731.5 (46.7–3102.0) |
652.5 (67.1–3809.5) |
3966.0 (616.0–10000.0) |
1632.0 (284.0–4923.0) |
1320.5 (283.5–4308.5) |
| TARC (pg/mL) LS mean change (SE) | 956.05 (1564.354) |
− 5770.96 (1489.830) 0.0018 |
− 5671.11 (1249.615) 0.0009 |
− 1071.60 (210.011) |
− 5569.19 (232.172) < 0.0001 |
− 5370.59 (203.903) < 0.0001 |
| TARC (pg/mL), median (Q1–Q3) | 1118.3 (669.0–3882.0) | 422.2 (215.5–657.7) | 393.6 (279.7–696.0) | 1385.0 (648.0–3527.0) | 407.0 (263.1–698.0) | 391.0 (246.5–633.5) |
DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, EASI-75 75% decrease in EASI, EQ-5D EuroQol – 5 Dimension, IGA Investigator’s Global Assessment, IgE Immunoglobulin E, IU international units, LS least squares, mL milliliter, NRS Numerical Rating Scale, N1, number of patients with baseline NRS score ≥ 3, pg picograms, POEM Patient-Oriented Eczema Measure, Q quartile, q2w every 2 weeks, qw every week, SCORAD SCORing Atopic Dermatitis, SE standard error, TARC thymus and activation-regulated chemokine, VAS visual analog scale