AE reported during the 2-year followup. Values are n (%) unless otherwise indicated.
| AE | Overall, n = 122 | IFX, n = 32 | ADA, n = 90 | p |
|---|---|---|---|---|
| Major AE | 0 | 0 | 0 | |
| Minor AE | ||||
| N events | 35 | 16 | 19 | |
| Patients | 20 (16.4) | 5 (15.6) | 15 (16.7) | > 0.999 |
| IR (95% CI) | 14.3 (10.0–19.9) | 25.0 (14.3–40.6) | 10.6 (6.4–16.5) | 0.008 |
| Infections | 15 (42.9) | 8 (50.0) | 7 (36.8) | 0.433 |
| URTI | 7 (20.0) | 4 (25.0) | 3 (15.8) | 0.677 |
| HZV | 4 (11.4) | 0 (0.0) | 4 (21.1) | 0.109 |
| UTI | 4 (11.4) | 4 (25.0) | 0 (0.0) | 0.035 |
| Infusion reactions | 2 (5.7) | 1 (6.3) | 1 (5.3) | > 0.999 |
| Systemic symptoms | ||||
| Headache | 9 (25.7) | 4 (25.0) | 5 (26.3) | > 0.999 |
| Irritability | 1 (2.9) | 1 (6.3) | 0 (0.0) | 0.457 |
| GI symptoms | 2 (5.7) | 1 (6.3) | 1 (5.3) | > 0.999 |
| Prolonged menses | 1 (2.9) | 0 (0.0) | 1 (5.3) | > 0.999 |
| BMI changes | 1 (2.9) | 1 (6.3) | 0 (0.0) | 0.457 |
| Skin reactions | 3 (8.6) | 0 (0.0) | 3 (15.8) | 0.234 |
| Fatigue | 1 (2.9) | 0 (0.0) | 1 (5.3) | > 0.999 |
AE: adverse events; IFX: infliximab; ADA: adalimumab; IR: incidence rate per 100 patient-years; URTI: upper respiratory tract infection; HZV: herpes zoster virus; UTI: urinary tract infection; GI: gastrointestinal; BMI: body mass index.