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]
| 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 |
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| 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 |
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| 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) |
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