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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