pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Efficacy outcomes of ECZTRA-7 and CAFE
| ECZTRA-7 | CAFÉ | |||
|---|---|---|---|---|
| Tralokinumab 300 mg Q2W + TCS (n=138) | Placebo+TCS (n=137) | Dupilumab 300 mg Q2W +TCS (n=107) | Placebo+TCS (n=108) | |
| Primary efficacy outcome | ||||
| EASI 75 at week 16 (% (n/N)) | 64.2% | 50.5% | 62.6% | 29.6% |
| (88.6/138) | (69.2/137) | (67/107) | (32/108) | |
| Secondary efficacy outcome | ||||
| Weekly average of worst daily P-NRS | 45.5% | 35.6% | 45.7% | 14.3% |
| reduction of ≥4 at week 16 (% (n/N)) | (61/134) | (48/135) | (43/94) | (13/91) |
| SCORAD score change at week 16 (±SE) | -42.7 (±1.6) | -34.1 (±1.6) | -62.4 (±2.48) | -29.5 (±2.55) |
| DLQI score change at week 16 (±SE) | n=137; -11.2 (± 0.4) | n=134; -9.6 (±0.4) | -9.5 (±0.46) | -4.5 (±0.49) |
| EASI 50 at week 16 (%(n/N)) | 80.0% | 69.5% | 85.0% | 43.5% |
| (110.4/138) | (95.3/137) | (91/107) | (47/108) | |
| EASI 90 at week 16 (%(n/N)) | 41.1% | 29.3% | 45.8% | 12.0% |
| (56.7/138) | (40.2/137) | (49/107) | (13/108) | |
TCS, Topical Corticosteroid; EASI, Eczema Area and Severity Index; P-NRS, Pruritus-Numerical Rating Scale; SCORAD, Scoring Atopic Dermatitis; DLQI, Disease-Specific Quality of Life measure; SE, Standard Error