Table 2 Clinical characteristics of the study sample at 6 months, 1 year, and 2 years
|  | IFX + MTX n = 38 | MTX n = 36 | PL n = 16 |
|---|---|---|---|
Clinical remission (primary endpoint), no. of patients in remission (%) | |||
 6 months | 10 (26%) | 6 (17%) | 0 |
 1 year | 12 (32%) | 5 (14%) | 0 |
 2 years | 9 (24%) | 1 (3%) | 3 (19%) |
Other definitions of remission, no. of patients in remission (%) | |||
 Disease Activity Score 28 (DAS28) |  | ||
  6 months | 20 (53%) | 11 (31%) | 1 (6%) |
  1 year | 24 (63%) | 13 (36%) | 3 (19%) |
  2 years | 23 (61%) | 11 (31%) | 5 (31%) |
 Simplified Disease Activity Index (SDAI) | |||
  6 months | 16 (42%) | 9 (25%) | 1 (6%) |
  1 year | 18 (47%) | 13 (36%) | 1 (6%) |
  2 years | 18 (47%) | 13 (36%) | 4 (25%) |
 ACR/EULAR Boolean | |||
  6 months | 15 (40%) | 8 (22%) | 0 |
  1 year | 13 (34%) | 9 (25%) | 1 (6%) |
  2 years | 13 (34%) | 10 (28%) | 4 (25%) |
 ACR improvement, responders |  | ||
  ACR20 |  | ||
   6 months | 20 (53%) | 18 (50%) | 4 (25%) |
   1 year | 22 (58%) | 22 (61%) | 3 (19%) |
   2 years | 19 (50%) | 19 (53%) | 3 (19%) |
  ACR50 | |||
   6 months | 16 (42%) | 13 (36%) | 1 (6%) |
   1 year | 17 (45%) | 16 (44%) | 3 (19%) |
   2 years | 14 (37%) | 15 (42%) | 3 (19%) |
  ACR70 | |||
   6 months | 15 (40%) | 6 (17%) | 1 (6%) |
   1 year | 14 (37%) | 11 (31%) | 2 (13%) |
   2 years | 13 (34%) | 11 (31%) | 3 (19%) |
Other secondary outcome parameters (mean ± SD) | |||
 Pain |  | ||
  6 months | 17.3 ± 20.3 | 22.5 ± 25.2 | 42.7 ± 31.0 |
  1 year | 20.9 ± 23.8 | 18.3 ± 25.3 | 45.7 ± 31.8 |
  2 years | 23.0 ± 25.1 | 23.3 ± 29.8 | 43.5 ± 32.8 |
 Swollen joints (28 joints) | |||
  6 months | 2.3 ± 5.2 | 2.1 ± 4.5 | 4.9 ± 5.6 |
  1 year | 2.3 ± 5.2 | 2.1 ± 4.3 | 5.0 ± 5.6 |
  2 years | 2.8 ± 5.6 | 2.4 ± 4.5 | 5.1 ± 5.6 |
 Tender joints (28 joints) | |||
  6 months | 2.9 ± 5.9 | 4.9 ± 6.2 | 7.0 ± 6.4 |
  1 year | 2.5 ± 5.6 | 4.2 ± 6.0 | 7.2 ± 6.8 |
  2 years | 3.4 ± 6.5 | 4.0 ± 6.1 | 7.1 ± 7.0 |
 Patient global visual analogue scale (VAS; mm) | |||
  6 months | 17.7 ± 6.5 | 23.1 ± 24.6 | 35.1 ± 28.2 |
  1 year | 21.2 ± 24.0 | 18.4 ± 24.7 | 38.0 ± 29.3 |
  2 years | 24.3 ± 25.3 | 24.8 ± 30.0 | 35.6 ± 29.5 |
 Evaluator global VAS (mm) | |||
  6 months | 16.1 ± 22.0 | 17.2 ± 24.1 | 34.6 ± 28.0 |
  1 year | 14.1 ± 20.8 | 17.7 ± 24.6 | 39.3 ± 29.8 |
  2 years | 16.6 ± 24.1 | 18.4 ± 24.7 | 34.5 ± 31.3 |
 C-reactive protein (mg/dl) | |||
  6 months | 0.5 ± 0.9 | 0.6 ± 1.0 | 0.8 ± 0.9 |
  1 year | 0.5 ± 0.9 | 0.5 ± 1.0 | 0.7 ± 0.8 |
  2 years | 0.6 ± 1.1 | 0.6 ± 1.0 | 0.5 ± 0.8 |
 Erythrocyte sedimentation rate (mm) | |||
  6 months | 14.6 ± 12.2 | 17.8 ± 12.5 | 14.9 ± 6.9 |
  1 year | 14.6 ± 12.3 | 18.7 ± 13.0 | 18.3 ± 9.7 |
  2 years | 16.5 ± 14.1 | 17.6 ± 11.2 | 16.5 ± 10.7 |
 Health Assessment Questionnaire (HAQ) | |||
  6 months | 0.30 ± 0.45 | 0.57 ± 0.64 | 0.54 ± 0.67 |
  1 year | 0.33 ± 0.46 | 0.52 ± 0.62 | 0.61 ± 0.66 |
  2 years | 0.41 ± 0.52 | 0.58 ± 0.61 | 0.62 ± 0.65 |
 X-raysa | |||
  6 months | −0.02 ± 0.88 | 0.07 ± 0.23 | 0.41 ± 1.53 |
  1 year | 0.18 ± 1.06 | 0.16 ± 0.44 | 0.0 ± 0.41 |
  2 years | 0.36 ± 0.95 | 0.28 ± 0.67 | 0.63 ± 1.31 |