Table 3.
Efficacy end points by ITT (MMRM) analysis.
| All patients (N=60) | Severe AD (Baseline SCORAD≥50) (N=32) (a) |
Non-Severe AD (Baseline SCORAD<50) (N=28) (a) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug (N=40) |
Placebo (N=20) |
p- value |
Drug (N=20) |
Placebo (N=12) |
p- value |
Drug (N=20) |
Placebo (N=8) |
p- value |
|
| SCORAD Decline (Mean ±SEM) | |||||||||
| Week 12 | −13·8 ±2·7 | −8·0 ±3·1 | 0·134 | −21·6 ±3·8 | −9·6 ±4·2 | 0·029 | −6·0 ±3·2 | −5·7 ±4·6 | 0·764 |
| Week 20 | −18·8 ±2·9 | −11·7 ±3·9 | 0·049 | −27·4 ±3·9 | −11·5 ±5·1 | 0·010 | −10·2 ±3·4 | −11·9 ±6·4 | 0·639 |
| SCORAD Improvement (Mean ±SEM) | |||||||||
| Week 12 | −24·4% ±5·0% | −14·7% ±5·9% | 0·175 | −34·4% ±6·1% | −15·8% ±7·4% | 0·039 | −14·3% ±7·4% | −13·1% ±10·1% | 0·897 |
| Week 20 | −34·1% ±5·4% | −23·0% ±7·4% | 0·072 | −43·9% ±6·6% | −20·6% ±8·8% | 0·028 | −24·2% ±8·0% | −26·6% ±13·8% | 0·794 |
| SCORAD30 (b) | |||||||||
| Week 12 | 42·5% | 20·0% | 0·150 | 55·0% | 16·7% | 0·062 | 30·0% | 25·0% | 1·000 |
| Week 20 | 52·5% | 30·0% | 0·168 | 65·0% | 16·7% | 0·012 | 40·0% | 50·0% | 0·691 |
| SCORAD50 (c) | |||||||||
| Week 12 | 22·5% | 15·0% | 0·734 | 30·0% | 16·7% | 0·676 | 15·0% | 12·5% | 1·000 |
| Week 20 | 37·5% | 25·0% | 0·395 | 45·0% | 16·7% | 0·139 | 30·0% | 37·5% | 1·000 |
| BSA Decline (Mean ±SEM) | |||||||||
| Week 12 | −12·4 ±2·4 | −6·2 ±2·7 | 0·009 | −15·7 ±3·6 | −6·3 ±4·5 | 0·011 | −9·0 ±3·1 | −6·1 ±1·6 | 0·347 |
| Week 20 | −17·7 ±3·2 | −7·6 ±2·9 | 0·001 | −23·3 ±4·7 | −6·8 ±4·7 | 0·009 | −12·2 ±4·2 | −8·8 ±1·9 | 0·357 |
| BSA Decline > 15 (d) | |||||||||
| Week 12 | 37.5% | 10.0% | 0.034 | 45.0% | 16.7% | 0.139 | 30.0% | 0.0% | 0.141 |
| Week 20 | 42.5% | 10.0% | 0.017 | 55.0% | 16.7% | 0.062 | 30.0% | 0.0% | 0.141 |
| IGA Decline (Mean ±SEM) | |||||||||
| Week 12 | −0·6 ±0·1 | −0·3 ±0·1 | 0·119 | −0·7 ±0·2 | −0·3 ±0·1 | 0·034 | −0·5 ±0·2 | −0·4 ±0·3 | 0·684 |
| Week 20 | −0·9 ±0·2 | −0·6 ±0·2 | 0·127 | −1·2 ±0·2 | −0·4 ±0·2 | 0·014 | −0·7 ±0·2 | −0·8 ±0·3 | 0·724 |
| IGA Complete Response (e) | |||||||||
| Week 12 | 15.0% | 5.0% | 0.407 | 20.0% | 0.0% | 0.271 | 10.0% | 12.5% | 1.000 |
| Week 20 | 25.0% | 15.0% | 0.513 | 35.0% | 8.3% | 0.204 | 15.0% | 25.0% | 0.606 |
Summary of responses by treatment arm at primary endpoint (week 12), and at end of study (week 20). Statistical significance of difference in mean decline between treatment arms was assessed by MMRM. Statistical significance of difference in % response between treatment arms was assessed by Fisher’s exact test. Significant results (p≤0·05) are in bold.
Severe patients are defined as patients with a SCORAD≥50 at week 0.
SCORAD30 is defined as SCORAD improvement >30% compared to week 0; a 30% threshold was selected because it is the 95% percentile of pre-treatment variation.
SCORAD50 is defined as SCORAD improvement >50% compared to week 0.
BSA (body surface area) decline threshold of 15 points was selected because it is the 95% percentile of pre-treatment variation.
IGA (Investigator Global Assessment) complete response is defined as IGA≤1 or IGA decline≥2 at the respective end-point.