TEAEs of special interest regardless of relationship to study treatment in the PLANETAS main and extension study, n (%) (safety population)
| TEAE | Maintenance group* (n=90) | Switch group† (n=84) |
|---|---|---|
| Main study period | ||
| Infusion-related reactions | 4 (4.4) | 7 (8.3) |
| Tuberculosis | 0 | 0 |
| Latent tuberculosis | 6 (6.7) | 3 (3.6) |
| Serious infection | 0 | 1 (1.2) |
| Pneumonia | 1 (1.1) | 0 |
| Drug-induced liver injury | 0 | 0 |
| Vascular disorders | 3 (3.3) | 1 (1.2) |
| Malignancies | 0 | 0 |
| Extension study period | ||
| Infusion-related reactions | 7 (7.8) | 6 (7.1) |
| Tuberculosis | 1 (1.1) | 1 (1.2) |
| Latent tuberculosis | 5 (5.6) | 7 (8.3) |
| Serious infection | 2 (2.2) | 1 (1.2) |
| Pneumonia | 0 | 0 |
| Drug-induced liver injury | 0 | 0 |
| Vascular disorders | 3 (3.3) | 2 (2.4) |
| Malignancies | 1 (1.1) | 0 |
*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.