- ACR20 response: RINVOQ 15 mg + MTX vs Placebo + MTX at Week 12
SELECT RANKED SECONDARY ENDPOINTS2
At Week 12 vs Placebo + MTX
- Change from baseline in DAS28-CRP
- Change from baseline in HAQ-DI
- Change from baseline in SF-36 (PCS)
- DAS28-CRP ≤ 3.2 (LDA)
- DAS28-CRP < 2.6 (CR)
At Week 12 vs Adalimumab + MTX
- ACR50 response (superiority)
- Change from baseline in Patient's assessment of pain (superiority)
- Change from baseline in HAQ-DI (superiority)
At Week 26 vs Placebo + MTX
- Change from baseline mTSS
SELECT PRESPECIFIED NONRANKED ENDPOINTS5-7
- ACR20/50/70 response rates at all visits (except those that were ranked timepoints)
- Proportion of patients achieving CR based on DAS28-CRP, DAS28-ESR, SDAI, CDAI, and Boolean criteria at all visits (except those that were ranked timepoints).
- Proportion of patients with no radiographic progression (mTSS ≤ 0) at Week 26
- Change from baseline in mTSS at Week 48
- Change from baseline in joint space narrowing score and joint erosion score at Week 26 and Week 48
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
SELECT-COMPARE was not designed to evaluate the efficacy of HUMIRA + MTX vs placebo + MTX. No conclusions regarding this comparison can be made.