Table 2.
Efficacy Outcomes.
| A. | ||||
|---|---|---|---|---|
| Placebo (N=20) | Dupilumab (N=40) | P-value | ||
| Change in SALT from baseline to week 24 (SE) | −6.3 (4.2) | 2.3 (3) | 0.049 | |
| Key secondary endpoints: | ||||
| Change in SALT from baseline to week 48 in the drug-first arm (SE) | NA | 13.7 (3) | <0.0001 | |
| Change in SALT from week 24 to week 48 in the placebo-first arm (SE) | 15.9 (4.7) | NA | 0.0006 | |
| Change in SALT from week 24 to week 48 in the placebo-first arm versus change in SALT from baseline to week 24 in the placebo-first arm (SE) | 22.3 (5.2) | NA | <0.0001 | |
| Change in SALT from week 24 to week 48 in the drug-first arm versus change in SALT from baseline to week 24 in the placebo-first arm (SE) | NA | 17.4 (7.3) | 0.019 | |
| Proportion of patients achieving SALT30/50/75/90 at week 24 | ||||
| ≥30% (SALT30) | 2 (10%) | 7 (17.5%) | 0.66 | |
| ≥50% (SALT50) | 0 (0%) | 4 (10%) | 0.23 | |
| ≥75% (SALT75) | 0 (0%) | 2 (5%) | 0.55 | |
| ≥90% (SALT90)3 | 0 (0%) | 1 (2%) | 1 | |
| Proportion of patients achieving SALT30/50/75/90 at week 48 (compared to placebo-first arm at week 24) | ||||
| ≥30% (SALT30) | 4 (20%) | 13 (32.5%) | 0.067 | |
| ≥50% (SALT50) | 3 (15%) | 9 (22.5%) | 0.02 | |
| ≥75% (SALT75) | 1 (5%) | 6 (15%) | 0.17 | |
| ≥90% (SALT90) 3 | 1 (5%) | 4 (10%) | 0.29 | |
| Proportion of patients achieving SALT30/50/75/90 after 24 weeks of dupilumab treatment 1 | ||||
| Placebo arm after weeks 24–48 (open-label Dupilumab treatment) (N=20) | Drug arm after weeks 0–24 (N=40) | All patients after 24 weeks of dupilumab treatment (N=60) | ||
| ≥30% (SALT30) | 4 (20%) | 7 (17.5%) | 11 (18.3%) | 0.19 |
| ≥50% (SALT50) | 3 (15%) | 4 (10%) | 7 (11.7%) | 0.08 |
| ≥75% (SALT75) | 1 (5%) | 2 (5%) | 3 (5%) | 0.54 |
| ≥90% (SALT90)3 | 1 (5%) | 1 (2%) | 2 (3.3%) | 0.55 |
| B. | ||||
| Proportion of patients achieving SALT30/50/75/90 in the drug arm at week 24 based on baseline IgE level (threshold: 200IU/ml) 2 | ||||
| Low IgE (N=27) | High IgE (N=13) | Entire drug arm (N=40) | ||
| ≥30% (SALT30) | 2 (7.4%) | 5 (38.5%) | 7 (17.5%) | 0.03 |
| ≥50% (SALT50) | 0 (0%) | 4 (30.8%) | 4 (10%) | 0.008 |
| ≥75% (SALT75) | 0 (0%) | 2 (15.4%) | 2 (5%) | 0.1 |
| ≥90% (SALT90)3 | 0 (0%) | 1 (7.7%) | 1 (2%) | 0.32 |
| Proportion of patients achieving SALT30/50/75/90 in the drug arm at week 48 based on baseline IgE level (threshold: 200IU/ml) 2 | ||||
| Low IgE (N=27) | High IgE (N=13) | All drug arm (N=40) | ||
| ≥30% (SALT30) | 6 (22.2%) | 7 (53.8%) | 13 (32.5%) | 0.07 |
| ≥50% (SALT50) | 3 (11.1%) | 6 (46.2%) | 9 (22.5%) | 0.04 |
| ≥75% (SALT75) | 1 (3.7%) | 5 (38.5%) | 6 (15%) | 0.009 |
| ≥90% (SALT90)3 | 1 (3.7%) | 3 (23.1%) | 4 (10%) | 0.09 |
SALT denotes severity of alopecia tool, SE standard error. Bolded values show P<0.05.
1
P-values represent comparison between all patients completing 24 weeks of dupilumab treatment versus placebo arm at week 24.
2
P-values for comparisons by IgE levels are between high and low IgE subgroups.
3
All four patients achieving SALT90 at week 48 had complete hair regrowth, which means they could also be regarded as SALT100.