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) |