Table 2

Patients in clinical remission at week 24/26 based on DAS28(CRP)<2.6 or SDAI≤3.3

DAS28(CRP)<2.6SDAI≤3.3
ADA+MTXPBO+MTXADA+MTXPBO+MTX
DE019 (MTX-IR) n=202n=191n=202n=191
Proportion in remission at week 2423%5%*10%2%*
Characteristics of patients in remission at week 24, mean (SD)n=46n=9n=21n=4
  DAS28(CRP)2.11 (0.33)2.06 (0.40)1.88 (0.32)1.65 (0.08)
  mTSS57.4 (58.1)41.4 (26.8)45.2 (46.7)41.6 (33.2)
  HAQ-DI0.40 (0.45)0.51 (0.68)0.33 (0.41)0.50 (0.84)
PREMIER (MTX-naive) n=267n=252n=267n=252
Proportion in remission at week 2637%19%*23%12%**
Characteristics of patients in remission at week 26, mean (SD)n=98n=48n=62n=31
  DAS28(CRP)1.95 (0.35)2.00 (0.35)1.78 (0.29)1.82 (0.27)
  mTSS17.2 (19.4)23.1 (24.9)15.5 (17.0)21.9 (28.6)
  HAQ-DI0.25 (0.40)0.22 (0.35)0.18 (0.28)0.18 (0.36)
OPTIMA (MTX-IR†) n=348NAn=348NA
Proportion in remission at week 2634%NA18%NA
Characteristics of patients in remission at week 26, mean (SD)n=120NAn=61NA
  DAS28(CRP)2.0 (0.37)NA1.71 (0.27)NA
  mTSS13.4 (19.9)NA14.9 (23.3)NA
  HAQ-DI0.47 (0.50)NA0.31 (0.40)NA
  • *p<0.0001 and **p=0.001 vs ADA+MTX, Fisher’s exact test; the last observation carried forward method was used to impute missing data for patients with postbaseline DAS28(CRP).

  • OPTIMA enrolled MTX-naive patients; the Rescue ADA arm included patients treated with placebo+MTX who did not achieve stable low disease activity (ie, MTX-IR patients) at week 22 or 26, and received open-label ADA+MTX for an additional 52 weeks.

  • ADA, adalimumab; DAS28(CRP), 28-joint Disease Activity Score based on C-reactive protein; HAQ-DI, Health Assessment Questionnaire Disability Index; IR, inadequate response; mTSS, modified total Sharp score; MTX, methotrexate; NA, not applicable; PBO, placebo; SDAI, Simplified Disease Activity Index.