Table 3.
AD exploratory efficacy outcomes at week 12
| Pooled | 12 μg/kg | 24 μg/kg | ||
|---|---|---|---|---|
| n | Placebo | REZPEG | REZPEG | |
| EASI % change from baseline, (SEM) | 7, 12, 12 | -47.2 (8.72) | -65.1 (6.57) | −83.0 (6.38) |
| Treatment difference (95% CI) | --- | -17.9 (-40.13, 4.38) | -35.8 (-57.78, -13.76) | |
| p-value | 0.112 | 0.002 | ||
| BSA % change from baseline, (SEM) | 7, 12, 12 | -36.4 (12.0) | -52.8 (8.90) | -73.1 (8.66) |
| Treatment difference (95% CI) | --- | -16.4 (-46.85, 13.98) | -36.7 (-66.84, -6.59) | |
| p-value | 0.279 | 0.019 | ||
| vIGA-AD % change from baseline, (SEM) | 7, 12, 12 | -29.7 (10.6) | -40.9 (7.80) | -56.0 (7.69) |
| Treatment difference (95% CI) | --- | -11.2 (-56.76, -25.02) | -26.3 (-71.63, -40.31) | |
| p-value | 0.400 | 0.053 | ||
| Itch NRS % change from baseline, (SEM) | 7, 12, 12 | -19.2 (12.5) | -52.0 (9.31) | -52.5 (9.25) |
| Treatment difference (95% CI) | --- | -32.8 (-71.06, -32.91) | -33.4 (-71.47, -33.56) | |
| p-value | 0.045 | 0.041 | ||
| POEM % change from baseline, (SEM) | 7, 12, 12 | -15.9 (14.5) | -44.2 (10.8) | -51.3 (10.5) |
| Treatment difference (95% CI) | --- | -28.4 (-65.31, 8.56) | -35.4 (-72.02, 1.17) | |
| p-value | 0.127 | 0.057 | ||
| DLQI % change from baseline, (SEM) | 7, 12, 12 | -10.9 (18.3) | -46.8 (13.4) | -76.1 (13.3) |
| Treatment difference (95% CI) | --- | -35.8 (-82.22, 10.53) | -65.1 (-111.41, -18.84) | |
| p-value | 0.125 | 0.008 | ||
| EASI-50, n (%) | 10, 16, 17 | 3 (30.0) | 11 (68.8) | 12 (70.6) |
| Treatment difference | --- | 38.8 | 40.6 | |
| EASI-75, n (%) | 10, 16, 17 | 2 (20.0) | 4 (25.0) | 7 (41.2) |
| Treatment difference | --- | 5.00 | 21.2 | |
| EASI-90, n (%) | 10, 16, 17 | 2 (20.0) | 2 (12.5) | 4 (23.5) |
| Treatment difference | --- | -7.50 | 3.50 | |
| vIGA-ADa, n (%) | 10, 16, 17 | 2 (20.0) | 3 (18.8) | 5 (29.4) |
| Treatment difference | --- | -1.20 | 9.40 | |
| Itch NRSb, n (%) | 10, 15, 15 | 4 (40.0) | 8 (53.3) | 7 (46.7) |
| Treatment difference | --- | 13.3 | 6.70 | |
| POEMc, n (%) | 10, 16, 17 | 3 (30.0) | 8 (50.0) | 11 (64.7) |
| Treatment difference | --- | 20.0 | 34.7 | |
| DLQId, n (%) | 10, 13, 16 | 3 (30.0) | 6 (46.2) | 12 (75.0) |
| Treatment difference | --- | 16.2 | 45.0 |
A mixed model for repeated measures (MMRM) was used to generate least-squares (LS) means for percent change from baseline in continuous efficacy variables with baseline score as the covariate, treatment arm and protocol-defined visit time and their interaction as the fixed factors. Visit time is also used as repeated measure to account for within-subject variability. Differences and their p-values were derived for treatment vs placebo based on LS means. Missing data were imputed with NRI for categorical endpoints. 10 ug/kg REZPEG group data were not included due to small sample size. BSA; body surface area; CI, confidence interval; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI-50, patients with a 50% decrease in EASI score; EASI-75, patients with a 75% decrease in EASI score; EASI-90, patients with a 90% decrease in EASI score; LS, least-squares; MMRM, Mixed Model for Repeated Measures; NRI, non-responder imputation; NRS, numeric rating scale; PBO, placebo; POEM, Patient-Oriented Eczema Measure; SEM, standard error of the mean; vIGA-AD, Validated Investigator Global Assessment for Atopic Dermatitis. aPatients with post-baseline vIGA-AD scores of 0 or 1, with ≥ 2-point improvement from baseline. bProportion with post-baseline itch scale reduced by ≥ 4 points among patients with baseline score ≥ 4. cProportion with post-baseline POEM score reduced by ≥ 4 points among patients with baseline score ≥ 4. dProportion with post-baseline DLQI score reduced by ≥ 4 points among patients with baseline score ≥ 4.