Venous thromboembolism in patients on tsDMARDs (randomised controlled trials)
| Study ID (trial) | Follow-up | Intervention | N | VTE (%) | Risk of bias |
| Placebo-controlled trials | |||||
| Burmester 2018 Lancet (SELECT-NEXT)91 | 12 | PBO | 221 | 0 (0) | Low |
| UPA 15 QD | 221 | 0 (0) | |||
| UPA 30 QD | 219 | 0 (0) | |||
| Dougados 2017 Ann Rheum Dis (RA-BUILD)92 | 24 | PBO | 228 | 0 (0.0) | Low |
| BAR 2 QD | 229 | 0 (0.0) | |||
| BAR 4 QD | 227 | 1 (0.4)* | |||
| Genovese 2018 Lancet (SELECT-BEYOND)96 | 24 | PBO | 169 | 0 (0) | Low |
| UPA 15 QD | 164 | 3 (1.8)† | |||
| UPA 30 QD | 165 | 1 (0.6)‡ | |||
| Head-to-head trials | |||||
| Fleischmann 2017 Arthritis Rheumatol (RA-BEGIN)95 | 52 | MTX Q1W mono | 210 | 1 (0.5)§ | Low |
| BAR 4 QD mono | 159 | 0 (0.0) | |||
| BAR 4 QD+MTX Q1W | 215 | 0 (0.0) | |||
| Taylor 2017 N Engl J Med (RA-BEAM)94 | 52 | BAR 4 QD | 487 | 1 (0.2)¶ | Low |
| ADA 40 Q2W | 330 | 0 (0.0) | |||
*Pulmonary embolism.
†One case of pulmonary embolism occurred during the 12-week PBO-controlled phase and two cases (one with concomitant deep venous thrombosis) between week 12 and week 24 in patients who switched from PBO to UPA15 (2/72=2.8%).
‡One case of pulmonary embolism in a patient who switched from PBO to UPA30 after week 12.
§Death by pulmonary thromboembolism.
¶Thrombophlebitis.
mono, monotherapy; QD, once daily; Q1W, once a week.