Table 2.
Summary of (a) significant baseline factors predictive of DAS28, SDAI, and CDAI remission induction after 36 weeks of full-dose etanercept-methotrexate therapy in the open-label period and (b) significant post-baseline factors predictive of DAS28, SDAI, and CDAI remission loss at a single time point in all treatment groups in the double-blind period of the PRESERVE trial
| (a) | ||
| Baseline predictors of remission induction | ||
| DAS28 | SDAI | CDAI |
| Continuous variables | ||
| • Younger age | • Younger age | • Younger age |
| • Lower BMI | • Lower BMI | • Lower BMI |
| • Lower DAS28, SDAI, and CDAI | • Lower DAS28, SDAI, and CDAI | • Lower DAS28, SDAI, and CDAI |
| • Lower HAQ | • Lower HAQ | • Lower HAQ |
| • Lower PGA and PtGA | • Lower PGA and PtGA | |
| Categorical variables | ||
|
Younger age (>40 vs. ≤40 years;
>40 to ≤65 vs. ≤40 years) |
Younger age (>40 vs. ≤40 years;
>40 to ≤65 vs. ≤40 years; ≥65 vs. <65 years) |
Younger age (>40 vs. ≤40 years;
>40 to ≤65 vs. ≤40 years; ≥65 vs. <65 years) |
| • Lower DAS28 (≤4.1) | • Lower SDAI (≤15.5) | • Lower CDAI (≤14.5) |
| • Lower HAQ (>0.5 to ≤1.0 vs. ≤0.5; >1.0 to ≤1.5 vs. ≤0.5; >1.5 vs. ≤0.5) | • Lower HAQ (>1.5 vs. ≤0.5) | • Lower HAQ (>1.5 vs. ≤0.5) |
| (b) | ||
| Post-baseline predictors of remission loss | ||
| DAS28 | SDAI | CDAI |
| • Lack of sustained DAS28 remission | ||
| • DAS28 at wk 36 | ||
| • DAS28, SDAI, and CDAI at wk 40 | • DAS28, SDAI, and CDAI at wk 40 | • DAS28 and CDAI at wk 40 |
| • ∆ in DAS28, SDAI, and CDAI from wk 36-40 | • ∆ in DAS28, SDAI, and CDAI from wk 36 to 40 | • ∆ in DAS28 and CDAI from wk 36 to 40 |
| • TJC and SJC at wk 40 | • TJC at wk 40 | |
| • ∆ in TJC and SJC from wk 36 to 40 | • ∆ in TJC from wk 36 to 40 | |
| • ESR at wk 40 | ||
| • ∆ in ESR from wk 36 to 40 | ||
| • ∆ in HAQ from wk 36 to 40 | • ∆ in HAQ from wk 36-40 | |
| • PGA, PtGA, general health VAS, and pain VAS at wk 40 | • PGA, PtGA, general health VAS, and pain VAS at wk 40 | • PGA, PtGA, general health VAS, and pain VAS at wk 40 |
| • ∆ in PGA, PtGA, general health VAS, and pain VAS from wk 36 to 40 | • ∆ in PGA, PtGA, general health VAS, and pain VAS from wk 36 to 40 | • ∆ in PGA, PtGA, general health VAS, and pain VAS from wk 36 to 40 |
Bold face denotes predictors of remission induction and remission loss across all three sets of criteria, i.e., Disease Activity Score in 28 joints (DAS28), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI)
BMI body mass index, HAQ Health Assessment Questionnaire, PGA physician global assessment, PtGA patient global assessment, TJC tender joint count, SJC swollen joint count, VAS visual analog scale