Variable | All | ETN+MTX | MTX-TT |
Demographics | |||
Age, years Mean (SD) | 50.0 (12.8) | 49.6 (12.5) | 50.3 (13.2) |
Female % (n/N) | 71 (85) | 65 (39) | 77 (46) |
RA presenting history, % (n/N) (unless otherwise stated) | |||
Symptom duration, weeks, median (Q1, Q3) | 20.3 (13.1 to 30.8) | 19.2 (12.5 to 28.1) | 20.8 (15.9 to 31.9) |
Previous IM steroid | 1 (1/120) | 0 (0/60) | 2 (1/60) |
Previous IA steroid | 0 (0/120) | 0 (0/60) | 0 (0/60) |
Concomitant oral steroid | 3 (3/120) | 0 (0/60) | 5 (3/60) |
Concomitant NSAID | 88 (105/120) | 92 (55/60) | 83 (50/60) |
RA disease phenotype, % (n/N) | |||
RF positive | 73 (87/120) | 70 (42/60) | 75 (45/60) |
ACPA positive | 84 (101/120) | 82 (49/60) | 87 (52/60) |
ANA positive | 15 (18/120) | 18 (11/60) | 12 (7/60) |
RA disease activity components, Median (Q1, Q3) (unless otherwise stated) | |||
TJC28 | 11.0 (7.0, 17.0) | 11.5 (6.0, 20.0) | 10.0 (7.0, 16.0) |
SJC28 | 5.0 (2.0, 9.0) | 5.0 (3.0, 10.5) | 5.0 (2.0, 9.0) |
ESR, mm/hour | 31.5 (18.5 to 51.0) | 30.5 (17.0 to 51.5) | 32.5 (20.5 to 51.0) |
CRP, mg/L | 8.8 (2.3, 24.0) | 10.2 (1.8, 28.0) | 8.0 (2.7, 21.5) |
Disease activity VAS, mm Mean (SD) | 57.1 (22.3) | 60.7 (21.6) | 53.6 (22.6) |
RA disease activity scores, Mean (SD) | |||
DAS28-ESR | 5.7 (1.1) | 5.8 (1.1) | 5.6 (1.0) |
DAS44-ESR | 3.7 (0.8) | 3.7 (0.9) | 3.7 (0.7) |
DAS28-CRP | 5.1 (1.2) | 5.2 (1.2) | 4.9 (1.1) |
DAS44-CRP | 3.4 (0.8) | 3.5 (0.9) | 3.3 (0.8) |
SDAI | 31.6 (13.7) | 34.2 (14.7) | 29.0 (12.3) |
CDAI | 29.8 (12.7) | 32.2 (13.6) | 27.3 (11.2) |
Patient-reported outcome measures, Mean (SD) (unless otherwise stated) | |||
Global pain VAS, mm | 53.5 (24.5) | 59.0 (23.4) | 48.1 (24.6) |
HAQ-DI | 1.2 (0.5) | 1.2 (0.5) | 1.1 (0.5) |
RAQoL | 17.3 (7.3) | 16.8 (7.4) | 17.9 (7.2) |
In paid work % (n/N) | 73 (88/120) | 82 (49/60) | 65 (39/60) |
EQ-5D-3L index | 0.5 (0.3) | 0.4 (0.3) | 0.5 (0.3) |
RAWIS | 18.2 (6.6) | 19.0 (6.7) | 17.3 (6.4) |
Ultrasound scores Median (Q1, Q3) | |||
Total GS score | 2.0 (0.0, 5.0) | 3.0 (0.5, 5.0) | 2.0 (0.0, 5.0) |
Total PD score | 0.0 (0.0, 2.5) | 0.0 (0.0, 3.0) | 0.0 (0.0, 2.0) |
Total erosion score | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) |
Radiographic score median (Q1, Q3) | |||
Total modified Sharp score | 2.5 (0.5, 6.0) | 2.0 (0.5, 5.0) | 2.5 (0.5, 6.3) |
ACPA, anticitrullinated protein antibody; ANA, antinuclear antibody; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, Disease Activity Score 28 joint; EQ-5D-3L, EuroQoL-5 Dimensions-3 Level; ESR, erythrocyte sedimentation rate; ETN, etanercept; GS, Grey Scale; HAQ-DI, Health Assessment Questionnaire Disability Index; IA, intra-articular; IM, intramuscular; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PD, power Doppler; RA, rheumatoid arthritis; RAQoL, Rheumatoid Arthritis Quality of life Questionnaire; RAWIS, Rheumatoid Arthritis Work Instability Scale; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; TT, treat-to-target; VAS, Visual Analogue Scale.