Treatment-related TEAEs that were reported in at least 1% of patients in either the maintenance group or the switch group (safety population)
| TEAE, n (%) | Maintenance group* (n=159) | Switch group† (n=143) | Total (n=302) |
|---|---|---|---|
| Main study period | |||
| Infusion-related reaction | 8 (5.0) | 13 (9.1) | 21 (7.0) |
| Abnormal liver function test | 11 (6.9) | 6 (4.2) | 17 (5.6) |
| Upper respiratory tract infection | 11 (6.9) | 6 (4.2) | 17 (5.6) |
| Latent TB | 8 (5.0) | 5 (3.5) | 13 (4.3) |
| Urinary tract infection | 6 (3.8) | 6 (4.2) | 12 (4.0) |
| Flare in RA activity | 6 (3.8) | 1 (0.7) | 7 (2.3) |
| Lower respiratory tract infection | 2 (1.3) | 4 (2.8) | 6 (2.0) |
| Anaemia | 1 (0.6) | 3 (2.1) | 4 (1.3) |
| Headache | 2 (1.3) | 1 (0.7) | 3 (1.0) |
| Herpes virus infection | 2 (1.3) | 1 (0.7) | 3 (1.0) |
| Vaginitis | 3 (1.9) | 0 | 3 (1.0) |
| Contusion | 2 (1.3) | 0 | 2 (0.7) |
| Diarrhoea | 2 (1.3) | 0 | 2 (0.7) |
| Psoriasis | 2 (1.3) | 0 | 2 (0.7) |
| Fever | 0 | 2 (1.4) | 2 (0.7) |
| Rash | 0 | 2 (1.4) | 2 (0.7) |
| Rhinitis | 0 | 2 (1.4) | 2 (0.7) |
| Uterine haemorrhage | 0 | 2 (1.4) | 2 (0.7) |
| Extension study period | |||
| Infusion-related reaction | 11 (6.9) | 4 (2.8) | 15 (5.0) |
| Latent TB | 9 (5.7) | 4 (2.8) | 13 (4.3) |
| Upper respiratory tract infection | 6 (3.8) | 3 (2.1) | 9 (3.0) |
| Lower respiratory tract infection | 4 (2.5) | 4 (2.8) | 8 (2.6) |
| Abnormal liver function test | 1 (0.6) | 4 (2.8) | 5 (1.7) |
| Urinary tract infection | 2 (1.3) | 2 (1.4) | 4 (1.3) |
| Bursitis | 2 (1.3) | 0 | 2 (0.7) |
| Urticaria | 0 | 2 (1.4) | 2 (0.7) |
*Patients treated with CT-P13 during the 54 weeks of the main study and the 48-week extension study.
†Patients treated with RP during the 54 weeks of the main study and then switched to CT-P13 during the 48-week extension study.
RA, rheumatoid arthritis; RP, reference product; TB, tuberculosis; TEAE, treatment-emergent adverse event.