Adverse events
| Group 1 (n=54) | Group 2 (n=44) | Group 3 (n=49) | Group 4 (n=52) | |
| Any AE | 30 (55.6) | 27 (61.4) | 26 (53.1) | 17 (32.7) |
| SAE | ||||
| Lung cancer | 0 (0) | 1 (2.3) | 0 (0) | 0 (0) |
| Fracture | 0 | 1 (2.3) | 1 (2.0) | 0 (0) |
| AE occurring in >5% of patients | ||||
| Upper respiratory infection | 26 (48.1) | 18 (40.9) | 20 (40.8) | 16 (30.8) |
| Dizziness | 1 (1.9) | 3 (6.8) | 0 (0) | 1 (1.9) |
| Injection site reaction | 3 (5.6) | 1 (2.3) | 2 (4.1) | 0 (0) |
| Headache | 3 (5.6) | 1 (2.3) | 1 (2.0) | 0 (0) |
| RA flare at any visit | 13 (24.1) | 15 (34.1) | 19 (38.8) | 11 (21.2) |
| RA flare at visit 4 | 4 (7.5) | 6 (14.0) | 9 (19.1) | 6 (12.0) |
| RA flare at last visit | 0 (0) | 0 (0) | 0 (0) | 1 (1.9) |
The data are expressed as num ber (%). RA flare was defined as an increase in DAS28 of >1.2 (or >0.6 if the DAS28 was ≥3.2).
AE, adverse event; DAS28, Disease Activity Score in 28 joints; RA, rheumatoid arthritis; SAE, serious adverse event.