Table 1.
Baseline demographics (effectiveness set; n=893)
| UST (n=438) | TNFi (n=455) | |
| Age years | 51.0 (12.5) (49.9; 52.2) | 48.5 (12.5) (47.3; 49.7) |
| Female, n (%) | 246 (56.2) (51.4; 60.9) | 248 (54.5) (49.8; 59.1) |
| BMI, kg/m2 | 28.6 (6.2) (27.9; 29.2) | 27.7 (5.3) (27.2; 28.2) |
| Disease duration since initial diagnosis, years | 7.5 (8.1) (6.7; 8.3) | 6.2 (6.6) (5.6; 6.9) |
| Line of bDMARD treatment, n (%) | ||
| First-line | 197 (45.0) (40.3; 49.8) | 251 (55.2) (50.5; 59.8) |
| Second-line | 151 (34.5) (30.0; 39.1) | 149 (32.7) (28.4; 37.3) |
| Third-line | 90 (20.5) (16.9; 24.6) | 55 (12.1) (9.2; 15.4) |
| csDMARD exposure, n (%) | ||
| Previous exposure | 384 (87.7) (84.2; 90.6) | 421 (92.5) (89.7; 94.8) |
| Ongoing exposure at baseline | 173 (39.5) (34.9; 44.2) | 251 (55.2) (50.5; 59.8) |
| MTX exposure ongoing at baseline | 131 (29.9) (25.7; 34.4) | 191 (42.0) (37.4; 46.7) |
| Weekly MTX dose, mg | 15.3 (5.5) (14.3; 16.3) | 15.0 (4.6) (14.3; 15.7) |
| Other treatments exposure ongoing at baseline, n (%) | ||
| NSAIDs | 240 (54.8) (50.0; 59.5) | 313 (68.8) (64.3; 73.0) |
| Glucocorticosteroids | 143 (32.6) (28.3; 37.3) | 156 (34.3) (29.9; 38.8) |
| Comorbidities present, n (%) | 301 (68.7) (64.1; 73.0) | 277 (60.9) (56.2; 65.4) |
| Cardiovascular disease/ metabolic syndrome* |
184 (42.0) (37.3; 46.8) | 162 (35.6) (31.2; 40.2) |
| Anxiety or panic disorders | 18 (4.1) (2.5; 6.4) | 18 (4.0) (2.4; 6.2) |
| Depression | 40 (9.1) (6.6; 12.2) | 29 (6.4) (4.3; 9.0) |
| GI disease or medical history of IBD | 55 (12.6) (9.6; 16.0) | 49 (10.8) (8.1; 14.0) |
| FiRST score suggestive of chronic widespread pain (scores ≥5) | 163 (39.0) (34.3; 43.9) | 126 (29.4) (25.2; 34.0) |
Data are mean (SD) (95% CI of the mean) unless otherwise stated; % is that of available data. Variables in bold indicate non-overlapping 95% CI.
*Hypertension, myocardial infarction, congestive heart failure, stroke or transient ischaemic attack, peripheral vascular disease, hyperlipidaemia, type 1 or type 2 diabetes or angina pectoris.
bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FiRST, Fibromyalgia Rapid Screening Tool; GI, gastrointestinal; IBD, inflammatory bowel disease; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; TNFi, tumour necrosis factor inhibitor; UST, ustekinumab.