Efficacy Outcomes at Wk 52
| Endpoints, % response unless specified otherwise | SEC 300 mg (N=426) | ADA 40 mg (N=427) | P-value (unadjusted)* |
|---|---|---|---|
| ACR20 | 67·4 | 61·5 | 0·0719 |
| aACR20 | 66·9 | 59·5 | 0·0239 |
| Key Secondary | |||
| bPASI 90 | 65·4 | 43·2 | <0·0001 |
| ACR50 | 49·0 | 44·8 | 0·2251 |
| HAQ-DI mean change from baseline ± SE | -0·58 ± 0.03 | -0·56 ± 0.03 | 0·5465 |
| cResolution of enthesitis (based on LEI) | 60·5 | 54·2 | 0·1498 |
| Exploratory | |||
| MDA | 43·0 | 37·9 | 0·1498 |
| VLDA | 18·1 | 16·6 | 0·6107 |
| DAPSA LDA+Remission | 61·7 | 53·1 | 0·0178 |
| PASDAS LDA+Remission | 51·1 | 44·1 | 0·0557 |
*Unadjusted P-values vs ADA
Binary variables were analysed using logistic regression. Pts who discontinued study treatment prematurely or took csDMARDs after week-36 were considered non-responders. Multiple imputation was used for all other missing data. HAQ-DI mean change from baseline was analysed using mixed-effect model repeated measures
aNon-responder imputation was used for pre-specified sensitivity analysis
bN=215 in SEC and N=202 in ADA in psoriasis subset
cN=234 in SEC and N=264 in ADA in enthesitis subset