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Table 1 Demographic and disease characteristics at baseline for the overall patient population (mITT) in the open-label period and for the treatment group subpopulations (mITT) in the randomized, double-blind period [6]

From: Predictors of remission with etanercept-methotrexate induction therapy and loss of remission with etanercept maintenance, reduction, or withdrawal in moderately active rheumatoid arthritis: results of the PRESERVE trial

  Open-label population Randomized population
Demographic/disease characteristics at baseline ETN 50 mg + MTX
N = 834
ETN 50 mg + MTX
n = 202
ETN 25 mg + MTX
n = 202
MTX
n = 200
Age, years 48.4 (11.9) 48.1 (12.0) 46.4 (12.2) 48.3 (12.2)
Female, n (%) 694 (83.2) 164 (81.2) 157 (77.7) 167 (83.5)
Prior tobacco use, n (%) 158 (18.9) 42 (20.8) 31 (15.4) 39 (19.5)
Disease duration, years 6.9 (7.0) 6.8 (7.2) 6.4 (7.1) 7.3 (6.7)
ACPA positive, n (%) 642 (77.6) 161 (80.1) 156 (77.6) 156 (78.8)
RF positive, n (%) 603 (72.7) 147 (73.1) 142 (70.7) 147 (74.2)
Clinical and patient-reported characteristics at baseline and randomization ETN 50 mg + MTX
N = 834
ETN 50 mg + MTX
n = 201
ETN 25 mg + MTX
n = 201
MTX
n = 197
Week 0 Week 0 Week 36 Week 0 Week 36 Week 0 Week 36
DAS28 4.4 (0.4) 4.3 (0.5) 2.0 (0.6) 4.4 (0.4) 2.1 (0.6) 4.3 (0.4) 2.1 (0.6)
SDAI 19.1 (5.1) 18.7 (4.8) 4.7 (3.6) 19.2 (5.1) 4.8 (3.2) 18.8 (5.4) 4.8 (3.2)
CDAI 17.8 (5.0) 17.5 (4.6) 4.1 (3.5) 17.9 (5.0) 4.2 (3.2) 17.8 (5.3) 4.3 (3.2)
TJC, 0–28 5.1 (2.9) 4.7 (2.7) 0.6 (1.2) 5.2 (2.9) 0.7 (1.3) 5.1 (2.9) 0.7 (1.2)
SJC, 0–28 3.8 (2.6) 3.9 (2.7) 0.6 (1.5) 3.8 (2.6) 0.6 (1.2) 4.0 (2.7) 0.6 (1.1)
CRP, mg/L 12.3 (16.4) 11.9 (13.9) 5.9 (5.9) 12.8 (18.0) 6.0 (6.5) 10.4 (13.1) 5.2 (3.3)
ESR, 0–100 mm/hour 22.2 (13.1) 22.2 (12.9) 9.9 (7.2) 21.7 (13.4) 10.7 (8.6) 20.4 (12.1) 9.6 (6.0)
PGA, 0–10 4.1 (1.3) 4.0 (1.3) 1.1 (0.9) 4.0 (1.3) 1.2 (1.1) 4.2 (1.3) 1.1 (0.8)
PtGA, 0–10 4.9 (1.7) 4.9 (1.8) 1.8 (1.7) 4.8 (1.7) 1.8 (1.5) 4.6 (1.7) 1.9 (1.6)
General health VAS, 0–100 mm 43.4 (17.0) 43.2 (17.3) 14.1 (15.8) 41.5 (15.5) 14.8 (15.0) 40.9 (15.6) 15.1 (15.5)
Pain VAS, 0–100 mm 45.5 (17.4) 46.1 (17.8) 12.8 (15.5) 43.1 (16.1) 13.8 (14.8) 44.1 (16.3) 14.2 (15.6)
Total HAQ, 0–3 1.1 (0.6) 1.1 (0.6) 0.5 (0.5) 1.1 (0.6) 0.5 (0.5) 1.1 (0.6) 0.5 (0.4)
Radiographic characteristics at baseline and randomization ETN 50 mg + MTX
N = 709
ETN 50 mg + MTX
n = 184
ETN 25 mg + MTX
n = 184
MTX
n = 167
Week 0 Week 0 Week 36 Week 0 Week 36 Week 0 Week 36
mTSS (0–448) 39.3 (55.3) 42.6 (58.8) 42.7 (58.8) 39.1 (60.3) 38.9 (59.8) 42.3 (47.5) 42.4 (47.6)
Erosion score (0–280) 24.8 (33.2) 25.8 (34.6) 25.8 (34.6) 24.7 (36.8) 24.7 (36.5) 26.2 (28.1) 26.1 (28.1)
JSN score (0–168) 14.5 (23.6) 16.8 (25.3) 16.9 (25.4) 14.4 (24.8) 14.2 (24.6) 16.1 (21.1) 16.1 (21.2)
  1. ACPA anti-citrullinated peptide antibody, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score based on a 28-joint count, ESR erythrocyte sedimentation rate, ETN etanercept, HAQ health assessment questionnaire, JSN joint space narrowing, mITT modified intention-to-treat, mTSS modified total Sharp score, MTX methotrexate, PGA physician global assessment, PtGA patient global assessment, RF rheumatoid factor, SDAI Simplified Disease Activity Index, SJC swollen joint count, TJC tender joint count, VAS visual analog scale