Table 5.
Efficacy assessment
| Efficacy assessment | Dupilumab 300 mg qw/q2w (N = 2677) | |||
|---|---|---|---|---|
| Week 52 (n = 2207) |
Week 100 (n = 1065) |
Week 148 (n = 557) |
Week 204 (n = 352) |
|
| Patients achieving IGA score 0 or 1 | 480/893 (53.8) | 593/1019 (58.2) | 53/71 (74.6) | 65/101 (64.4) |
| Patients achieving a reduction in IGA score of ≥2 PSBL [n/N2 (%)] | 659/882 (74.7) | 772/999 (77.3) | 63/71 (88.7) | 80/99 (80.8) |
| Patients achieving EASI-50 | 860/883 (97.4) | 984/999 (98.5) | 70/71 (98.6) | 94/99 (94.9) |
| Patients achieving EASI-75 | 784/883 (88.8) | 913/999 (91.4) | 69/71 (97.2) | 90/99 (90.9) |
| Patients achieving EASI-90 | 604/883 (68.4) | 729/999 (73.0) | 62/71 (87.3) | 75/99 (75.8) |
| EASI (primary analysis) (observed value) | 3.15 ± 4.57 | 2.60 ± 3.63 | 1.39 ± 3.01 | 2.46 ± 3.98 |
| OC (sensitivity analysis) | 3.4 (0.26) | 2.2 (0.16) | 1.4 (0.39) | 0.9 (0.53) |
| LOCF (sensitivity analysis) | 3.82 (0.31) | 2.87 (0.28) | 2.74 (0.29) | 3.63 (0.35) |
| Change in EASI from PSBL (observed value) | −29.10 ± 13.43 | −31.36 ± 14.09 | −29.20 ± 13.23 | −32.94 ± 14.50 |
| OC (sensitivity analysis) | −27.8 (0.72) | −29.0 (0.75) | −27.4 (1.91) | −29.7 (4.04) |
| LOCF (sensitivity analysis) | −27.52 (0.71) | −28.47 (0.71) | −28.60 (0.71) | −27.71 (0.74) |
| Percent change in EASI from PSBL (%) | −90.01 ± 14.18 | −91.54 ± 12.54 | −95.51 ± 8.70 | −91.07 ± 18.10 |
| Weekly Pruritus NRS score (primary analysis) (observed value) | 2.37 ± 1.78 | 2.32 ± 1.84 | 2.11 ± 1.75 | 2.10 ± 1.83 |
| OC (sensitivity analysis) | 2.3 (0.12) | 2.2 (0.12) | 2.1 (0.14) | 2.6 (0.42) |
| LOCF (sensitivity analysis) | 2.41 (0.09) | 2.26 (0.10) | 2.12 (0.10) | 2.77 (0.11) |
| Change in weekly Pruritus NRS score from PSBL (primary analysis) (observed value) | −4.76 ± 2.31 | −4.69 ± 2.32 | −4.62 ± 2.29 | −4.83 ± 2.34 |
| OC (sensitivity analysis) | −4.1 (0.16) | −4.2 (0.17) | −4.2 (0.19) | −4.0 (0.62) |
| LOCF (sensitivity analysis) | −4.13 (0.13) | −4.27 (0.13) | −4.43 (0.13) | −3.78 (0.14) |
| Percent change in weekly Pruritus NRS score from PSBL (%) | −65.18 ± 29.11 | −65.71 ± 30.11 | −67.61 ± 26.68 | −68.74 ± 29.85 |
| Patients achieving ≥3-point reduction in weekly Pruritus NRS score from PSBL | 1258/1609 (78.2) | 702/893 (78.6) | 336/429 (78.3) | 159/202 (78.7) |
| Patients achieving ≥4-point reduction in weekly Pruritus NRS score from PSBL | 1076/1609 (66.9) | 587/893 (65.7) | 278/429 (64.8) | 143/202 (70.8) |
| Patients who switched from dupilumab 300 qw to 300 q2w | ||||
| Patients with IGA score 0 or 1 | ||||
| 48 weeks before BL of q2w dosing | 75/114 (65.8) | |||
| BL of q2w dosing | 170/226 (75.2) | |||
| 48 weeks after BL of q2w dosing | 119/156 (76.3) | |||
| EASI | ||||
| 48 weeks before BL of q2w dosing | 2.58 ± 3.72 | |||
| BL of q2w dosing | 1.92 ± 3.53 | |||
| 48 weeks after BL of q2w dosing | 1.93 ± 4.48 | |||
| Weekly Pruritus NRS score | ||||
| 48 weeks before BL of q2w dosing | 2.16 ± 1.73 | |||
| BL of q2w dosing | 2.15 ± 1.84 | |||
| 48 weeks after BL of q2w dosing | 2.24 ± 1.90 | |||
BL of q2w dosing is defined as the last assessment on qw dose. Data are presented as n/N1 (%), mean (standard error), or mean ± standard deviation unless otherwise indicated
BL baseline, EASI Eczema Area and Severity Index, EASI-50/-75/-90 ≥50%/75%/90% reduction in EASI from BL, IGA Investigator’s Global Assessment, LOCF last observation carried forward, N1 number of patients with non-missing values, N2 number of patients with IGA score ≥2 at PSBL, NRS numerical rating scale, OC observed cohort, PSBL parent study BL, q2w every 2 weeks, qw weekly