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Table 2 Clinical characteristics of the study sample at 6 months, 1 year, and 2 years

From: Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial

  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
  1. Missing data for continuous variables were imputed using last observation carried forward (LOCF). LOCF was also applied from the time points onwards when patients received other DMARDs as rescue therapy. The denominator for the percentages given is the number of patients initially included in each group and stays consistent for each year
  2. ACR American College of Rheumatology, EULAR European League Against Rheumatism, IFX infliximab, MTX methotrexate, PL placebo
  3. aMean change of scores ± SD from baseline of Sharp-van-der-Heijde (SvdH) for patients with complete follow-up data at each time point