Table 2. Changes in clinical efficacy endpoints from baseline to week 16.
| Outcome | Placebo (n = 25) | Autologous total IgG (n = 26) | Difference in percentage change for autologous total IgG vs placebo, LS mean (95% CI) | P value | ||||
|---|---|---|---|---|---|---|---|---|
| Baseline, mean (SD) | Week 16, mean (SD) | Percentage change from baseline, LS mean (95% CI) | Baseline, mean (SD) | Week 16, mean (SD) | Percentage change from baseline, LS mean (95% CI) | |||
| EASI score | 37.3 (12.3) | 29.6 (18.9) | −20.3% (−32.0 to −8.7) | 40.5 (10.9) | 14.1 (10.2) | −64.8% (−76.2 to −53.4) | −44.4% (−60.7 to −28.2) | < 0.001 |
| SCORAD score | 77.5 (11.7) | 64.8 (22.2) | −16.8% (−24.4 to −9.2) | 79.4 (8.7) | 49.3 (18.6) | −37.8% (−45.2 to −30.3) | −21.0% (−31.6 to −10.3) | < 0.001 |
| DLQI score | 18.2 (7.4) | 16.2 (9.4) | −14.4% (−26.4 to −2.4) | 17.6 (5.8) | 11.2 (7.2) | −35.4% (−47.2 to −23.7) | −21.0% (−37.8 to −4.2) | 0.015 |
| Body surface area affected (%) | 61.4 (14.7) | 50.7 (26.3) | −19.1% (−29.3 to −8.9) | 64.0 (14.8) | 29.6 (18.1) | −53.9% (−63.9 to −43.9) | −34.8% (−49.1 to −20.5) | < 0.001 |
| EASI-50 at week 16* | 7/24 (29.2) | 18/25 (72.0) | - | 0.003 | ||||
| EASI-75 at week 16* | 3/24 (12.5) | 12/25 (48.0) | - | 0.007 | ||||
| Reduction in IGA score ≥ 2 points from baseline at week 16* | 6/24 (25.0) | 14/25 (56.0) | - | 0.027 | ||||
Data are presented as mean (standard deviation, SD) or number (%).
EASI, Eczema Area and Severity Index; SCORAD, SCORing Atopic Dermatitis; DLQI, Dermatology Life Quality Index; IGA, Investigator's Global Assessment; LS, least squares; CI, confidence interval; IgG, immunoglobulin G; EASI-50, proportion of patients achieving at least a 50% reduction in the EASI score from baseline; EASI-75, proportion of patients achieving at least a 75% reduction in the EASI score from baseline.
*The number of patients with EASI and IGA scores at week 16 was 24 for the placebo group and 25 for the autologous total IgG group.