APPENDIX 2.

Summary of change from baseline in the ACR core set measures at Week 104 (intent-to-treat population).

SJC, 66 Joint CountTJC, 68 Joint CountPatient Global VAS, mmPhysician Global VAS, mmPatient Pain VAS, mmCRP, mg/dlESR, mm/hHAQ-DI
Placebo-MTX, n = 393
  n391391137139137139139127
  Mean−3.5−5.9−33.2−43.9−25.6−1.6346−30.7−0.50
  SD11.6517.0726.3521.5524.442.2800122.260.612
  Median−2.0−3.0−33.0−47.0−28.0−0.8890−30.0−0.50
  Minimum-maximum−58 to 43−65 to 42−89 to 29−87 to 25−78 to 45−14.927 to 1.150−108 to 30−2.3 to 1.4
4 mg/kg tocilizumab-MTX, n = 399
  n399399228229228231231218
  Mean−9.0−13.6−31.6−49.1−26.6−1.6863−35.4−0.58
  SD10.7616.5327.0520.3325.392.2096525.070.608
  Median−8.0−13.0−32.0−50.0−26.0−1.0820−32.0−0.50
  Minimum-maximum−57 to 21−68 to 35−100 to 60−94 to 22−100 to 36−12.240 to 5.140−117 to 55−3.0 to 1.1
8 mg/kg tocilizumab-MTX, n = 398
  n397397248250248251247231
  Mean−11.3−17.7−33.9−48.7−28.9−2.3068−36.9−0.61
  SD11.3116.7326.6022.2025.472.6525623.390.661
  Median−10.0−17.0−32.5−50.0−27.0−1.5400−33.0−0.50
  Minimum-maximum−62 to 48−67 to 48−95 to 39−97 to 48−96 to 34−19.281 to 3.359−114 to 57−2.9 to 1.5
  • Last-observation-carried-forward was used for TJC and SJC; no imputation was used for missing HAQ score, CRP, ESR, and VAS assessments. All assessments were set to missing from the time a patient receives escape therapy, and only pre-escape therapy joint count assessments were carried forward. CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire Disability Index; SJC: swollen joint count; TJC: tender joint count; VAS: visual analog scale; ACR: American College of Rheumatology; MTX: methotrexate.