Adverse events and RA disease activity
| MTX continue (n=156) | MTX hold (n=160) | P values | |
| Any AE (%) | 34 (21.8) | 45 (28.1) | 0.194 |
| SAE (%) | 0 (0) | 0 (0) | 1.000 |
| AE occurring in >1% of patients (%) | |||
| Upper respiratory infection | 12 (7.7) | 9 (5.6) | 0.461 |
| Myalgia | 5 (3.2) | 10 (6.3) | 0.203 |
| Injection site reaction | 4 (2.6) | 6 (3.8) | 0.750 |
| Abdominal pain | 3 (1.9) | 1 (0.6) | 0.366 |
| Rash | 2 (1.3) | 2 (1.3) | 1.000 |
| Fatigue | 0 (0) | 2 (1.3) | 0.498 |
| Sore throat | 0 (0) | 2 (1.3) | 0.498 |
| Dizziness | 2 (1.3) | 0 (0) | 0.243 |
| DAS28 at visit 1 (0–100) | 2.2 (0.9) | 2.3 (1.1) | 0.517 |
| DAS28 at visit 2 (1–100) | 2.3 (0.9) | 2.4 (1.1) | 0.220 |
| Rescue medication (%) | 7 (4.5) | 10 (6.3) | 0.487 |
| RA flare at visit 2 (%) | 8 (5.1) | 17 (10.6) | 0.070 |
The data are expressed as mean (SD) or number (%). 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; MTX, methotrexate; RA, rheumatoid arthritis; SAE, serious adverse event.