Adverse events (AEs)
| Patients (n (%)) | ||
|---|---|---|
| Parameter | Adalimumab+MTX (n=171) | MTX (n=163) |
| Any AE | 138 (80.7) | 117 (71.8) |
| Severe AE | 1 (0.6) | 1 (0.6) |
| Serious AE | 7 (4.1) | 4 (2.4) |
| Infectious AE | 59 (34.5) | 48 (29.4) |
| Serious infection | 2 (1.2) | 1 (0.6) |
| AEs leading to study drug discontinuation | 7 (4.1) | 6 (3.7) |
| AEs of interest | ||
| Elevated liver function test level | 32 (18.7)† | 21 (12.9)† |
| Injection-site reaction | 18 (10.5)* | 6 (3.7) |
| Haematological event | 7 (4.1) | 8 (4.9) |
| Allergic reaction | 1 (0.6) | 2 (1.2) |
| Interstitial lung disease | 1 (0.6) | 1 (0.6) |
| Lupus-like syndrome | 0 | 1 (0.6) |
| Opportunistic infection | 0 | 1 (0.6) |
*p=0.02 versus MTX.
†≥94% of events were mild in severity.
MTX, methotrexate.