Table 2.
Summary of efficacy outcomes at week 4
| Vehicle | n | Difamilast 0·3% | n | P‐valuea | Difamilast 1% | n | P‐valuea | |
|---|---|---|---|---|---|---|---|---|
| Success rate in IGA score (%) | 18·1 | 83 | 44·6 | 83 | < 0·001 | 47·1 | 85 | < 0·001 |
| EASI 50 responder rateb,c | 26 (31·3) | 83 | 58 (69·9) | 83 | < 0·001 | 58 (68·2) | 85 | < 0·001 |
| EASI 75 responder rateb,c | 15 (18·1) | 83 | 36 (43·4) | 83 | < 0·001 | 49 (57·7) | 85 | < 0·001 |
| EASI 90 responder rateb,c | 6 (7·2) | 83 | 27 (32·5) | 83 | < 0·001 | 35 (41·2) | 85 | < 0·001 |
| Mean (SE) LS percentage change from baseline in overall EASI scores | –1·5 (8·6) | 59 | –43·8 (8·0) | 77 | < 0·001 | –62·6 (8·0) | 77 | < 0·001 |
| Mean (SE) LS mean change from baseline in overall EASI score | 0·35 (0·90) | 59 | –4·97 (0·84) | 77 | < 0·001 | –6·07 (0·84) | 77 | < 0·001 |
| Erythema subscale scored | –0·67 (0·28) | 59 | –2·57 (0·26) | 77 | < 0·001 | –3·10 (0·26) | 77 | < 0·001 |
| Induration/papulation subscale scored | –0·55 (0·28) | 59 | –2·17 (0·26) | 77 | < 0·001 | –2·55 (0·26) | 77 | < 0·001 |
| Excoriation subscale scored | –0·60 (0·28) | 59 | –2·27 (0·26) | 77 | < 0·001 | –2·62 (0·26) | 77 | < 0·001 |
| Lichenification subscale scored | –0·42 (0·25) | 59 | –1·97 (0·23) | 77 | < 0·001 | –2·31 (0·23) | 77 | < 0·001 |
| Mean (SE) LS change from baseline in VRS for pruritus score (for patients aged 7–14 years) | –0·33 (0·13) | 33 | –0·80 (0·12) | 38 | 0·01 | –0·68 (0·12) | 41 | 0·048 |
| Mean (SE) LS change from baseline in POEM score | –0·21 (0·64) | 59 | –3·54 (0·59) | 77 | < 0·001 | –3·98 (0·59) | 77 | < 0·001 |
| Mean (SE) LS change from baseline in percentage of affected BSA | 0·72 (1·63) | 59 | –8·37 (1·52) | 77 | < 0·001 | –10·99 (1·52) | 77 | < 0·001 |
BSA, Body Surface Area; EASI, Eczema Area and Severity Index; IGA, Investigator Global Assessment; LS, least square; POEM, Patient‐Oriented Eczema Measure; VRS, Verbal Rating Scale. a P‐values are for the comparison between each difamilast group and the vehicle group. bData are number of responders (%). cThe responder rates of EASI 50, EASI 75 and EASI 90 represent the percentages of patients who indicated at least 50%, 75% and 90% improvements in overall EASI score at week 4, respectively. dLS mean change from baseline in each EASI subscale score at week 4 (SE).