TEAEs of special interest regardless of relationship to study treatment in the PLANETRA main study and the extension study (safety population)
| TEAE, n (%) | Maintenance group* (n=159) | Switch group† (n=143) |
|---|---|---|
| Main study period | ||
| Infusion-related reactions | 8 (5.0) | 13 (9.1) |
| TB | 0 | 0 |
| Latent TB‡ | 12 (7.6) | 6 (4.2) |
| Serious infection§ | 2 (1.3) | 1 (0.7) |
| Pneumonia§ | 1 (0.6) | 1 (0.7) |
| Drug-induced liver injury | 0 | 0 |
| Vascular disorders | 12 (7.2) | 7 (4.9) |
| Malignancies | 0 | 0 |
| Extension study period | ||
| Infusion-related reactions | 11 (6.9) | 4 (2.8) |
| TB | 0 | 0 |
| Latent TB‡ | 11 (6.9) | 7 (4.9) |
| Serious infection | 4 (2.5) | 3 (2.1) |
| Pneumonia | 1 (0.6) | 0 |
| Drug-induced liver injury | 0 | 0 |
| Vascular disorders | 4 (2.5) | 3 (2.1) |
| Malignancies | 2 (1.3) | 3 (2.1) |
*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.
‡There were three patients (two in the maintenance group, one in the switch group) with three events of latent TB, which were reported both in the main study and in the extension study; this was because all three events started during week 62 (part of the end-of-study period of the main study).
§There was one patient in the maintenance group with a serious AE of pneumonia, which was included as a ‘Serious infection’ and ‘Pneumonia’ during the main study.
AE, adverse event; RP, reference product; TB, tuberculosis; TEAE, treatment-emergent adverse event.