Table 3.
Efficacy assessment
| Dupilumab 300 mg qw [N = 2677] | |||
|---|---|---|---|
| Week 100 [n = 1028] | Week 124 [n = 529] | Week 148a [n = 347] | |
| Patients achieving IGA 0 or 1 [n/N1 (%)] | 589/1014 (58.1) | 271/458 (59.2) | 43/58 (74.1) |
| Patients achieving a reduction in IGA of ≥ 2 from baseline of the parent study [n/N1 (%)] | 769/996 (77.2) | 359/457 (78.6) | 58/66 (87.9) |
| Patients achieving EASI-50 [n/N1 (%)] | 979/994 (98.5) | 445/453 (98.2) | 57/58 (98.3) |
| Patients achieving EASI-75 [n/N1 (%)] | 908/994 (91.3) | 416/453 (91.8) | 56/58 (96.6) |
| Patients achieving EASI-90 [n/N1 (%)] | 724/994 (72.8) | 337/453 (74.4) | 51/58 (87.9) |
| EASI (primary analysis), observed values [mean (SD)] | 2.6 (3.6) | 2.3 (3.5) | 1.4 (3.2) |
| OC (sensitivity analysis) [mean (SE)] | 2.6 (0.1) | 2.3 (0.2) | 1.5 (0.4) |
| LOCF (sensitivity analysis) [mean (SE)] | 3.6 (0.2) | 3.6 (0.2) | 3.6 (0.2) |
| MI (sensitivity analysis) [mean (SE)] | 2.9 (0.1) | 2.8 (0.1) | 3.5 (0.1) |
| Change in EASI from baseline of the parent study, observed values [mean (SD)] | − 31.3 (14.1) | − 30.0 (13.6) | − 29.2 (14.2) |
| LOCF (sensitivity analysis) [mean (SE)] | − 29.8 (0.4) | − 29.8 (0.4) | − 29.8 (0.4) |
| MI (sensitivity analysis) [mean (SE)] | − 30.6 (0.4) | − 30.7 (0.4) | − 30.1 (0.4) |
| Percentage change in EASI from baseline of the parent study, % [mean (SD)] | − 91.5 (12.6) | − 92.3 (11.0) | − 95.4 (9.3) |
| Weekly Pruritus NRS (primary analysis), observed values [mean (SD)] | 2.3 (1.9) | 2.3 (1.8) | 2.2 (1.8) |
| OC (sensitivity analysis), mean (SE) | 2.3 (0.1) | 2.3 (0.1) | 2.1 (0.1) |
| LOCF (sensitivity analysis), mean (SE) | 2.5 (0.1) | 2.6 (0.1) | 2.6 (0.1) |
| MI (sensitivity analysis), mean (SE) | 2.4 (0.1) | 2.6 (0.1) | 2.5 (0.1) |
| Change in weekly Pruritus NRS from baseline of the parent study (primary analysis), observed values [mean (SD)] | − 4.7 (2.3) | − 4.5 (2.4) | − 4.4 (2.4) |
| LOCF (sensitivity analysis) [mean (SE)] | − 4.7 (0.1) | − 4.6 (0.1) | − 4.6 (0.1) |
| MI (sensitivity analysis) [mean (SE)] | − 4.8 (0.1) | − 4.6 (0.1) | − 4.7 (0.1) |
| Percent change in weekly Pruritus NRS from baseline of the parent study, % [mean (SD)] | − 65.7 (30.2) | − 64.2 (33.4) | − 65.4 (28.5) |
| Patients achieving ≥ 3 reduction in weekly Pruritus NRS from baseline of the parent study [n/N1 (%)] | 604/764 (79.1) | 313/416 (75.2) | 168/224 (75.0) |
| Patients achieving weekly average Pruritus NRS ≤ 3 [n/N1 (%)] | 686/888 (77.3) | 395/510 (77.5) | 217/265 (81.9) |
| POEM score [mean (SD)] | 5.4 (5.1) | 5.1 (5.3) | N/A |
| DLQI [mean (SD)] | 2.9 (3.9) | 2.9 (4.3) | N/A |
DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, EASI-50 ≥ 50% reduction in EASI from baseline, EASI-75 ≥ 75% reduction in EASI from baseline, EASI-90 ≥ 90% reduction in EASI from baseline, IGA Investigator’s Global Assessment, LOCF last observation carried forward, MI multiple imputation, N1 number of patients with non-missing values, NRS Numerical Rating Scale, POEM Patient-Oriented Eczema Measure, OC observed cohort, qw weekly, SD standard deviation, SE standard error
aThe relatively low patient numbers at week 148 for IGA and EASI resulted from the temporary removal of these assessments from the end-of-treatment visit with the adoption of Amendment 6 that were restored as of Amendment 7