Treatment-related TEAEs reported in at least 1% of patients in total, n (%) (safety population)
| TEAE | Maintenance group* (n=90) | Switch group† (n=84) | Total (N=174) |
|---|---|---|---|
| Main study period | |||
| Abnormal liver function test | 9 (10.0) | 8 (9.5) | 17 (9.8) |
| Upper respiratory tract infection | 8 (8.9) | 6 (7.1) | 14 (8.0) |
| Infusion-related reaction | 4 (4.4) | 7 (8.3) | 11 (6.3) |
| Latent tuberculosis | 6 (6.7) | 3 (3.6) | 9 (5.2) |
| Urinary tract infection | 4 (4.4) | 2 (2.4) | 6 (3.4) |
| Neutropenia | 3 (3.3) | 2 (2.4) | 5 (2.9) |
| Rash | 2 (2.2) | 3 (3.6) | 5 (2.9) |
| Headache | 3 (3.3) | 1 (1.2) | 4 (2.3) |
| Elevated serum creatine kinase | 2 (2.2) | 2 (2.4) | 4 (2.3) |
| Sinusitis | 2 (2.2) | 1 (1.2) | 3 (1.7) |
| Dizziness | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Herpes virus infection | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Hypertension | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Weight increased | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Leucopenia | 0 | 2 (2.4) | 2 (1.1) |
| Extension study period | |||
| Infusion-related reactions | 7 (7.8) | 6 (7.1) | 13 (7.5) |
| Abnormal liver function test | 4 (4.4) | 4 (4.8) | 8 (4.6) |
| Latent tuberculosis | 2 (2.2) | 4 (4.8) | 6 (3.4) |
| Upper respiratory tract infection | 3 (3.3) | 2 (2.4) | 5 (2.9) |
| Elevated serum creatine kinase | 2 (2.2) | 1 (1.2) | 3 (1.7) |
| Lower respiratory tract infection | 2 (2.2) | 1 (1.2) | 3 (1.7) |
| Back pain | 0 | 3 (3.6) | 3 (1.7) |
| Cough | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Hypophosphataemia | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Tuberculosis | 1 (1.1) | 1 (1.2) | 2 (1.1) |
| Weight decreased | 1 (1.1) | 1 (1.2) | 2 (1.1) |
*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.
RP, reference product; TEAE, treatment-emergent adverse event.