TABLE 3.
Summary of adverse events in all patients.
| Telitacicept 160 mg (N = 14) | Telitacicept 240 mg (N = 15) | All patients (N = 29) | |
|---|---|---|---|
| AE, n (%) | 11 (78.6) | 15 (100.0) | 26 (89.7) |
| ADR, n (%) | 9 (64.3) | 12 (80.0) | 21 (72.4) |
| SAE, n (%) | 1 (7.1) | 0 (0) | 1 (3.4) |
| SADR, n (%) | 0 (0) | 0 (0) | 0 (0) |
| AE leading to dosing interruption, n (%) | 1 (7.1) | 1 (6.7) | 2 (6.9) |
| ADR leading to dosing interruption, n (%) | 1 (7.1) | 1 (6.7) | 2 (6.9) |
| AE leading to discontinuation n (%) | 0 (0) | 0 (0) | 0 (0) |
| Withdrawal owing to AE, n (%) | 0 (0) | 0 (0) | 0 (0) |
| Severe AE, n (%) | 1 (7.1) | 0 (0) | 1 (3.4) |
| Severe ADR, n (%) | 1 (7.1) | 0 (0) | 1 (3.4) |
| Death, n (%) | 0 (0) | 0 (0) | 0 (0) |
| Most common TEAEs (occurring in ≥2 patients in any group), n (%) | |||
| Upper respiratory tract infection | 4 (28.6) | 3 (20.0) | 7 (24.1) |
| Blood immunoglobulin M decreased | 3 (21.4) | 4 (26.7) | 7 (24.1) |
| Blood immunoglobulin A decreased | 2 (14.3) | 4 (26.7) | 6 (20.7) |
| Diarrhea | 2 (14.3) | 3 (20.0) | 5 (17.2) |
| Blood immunoglobulin G decreased | 3 (21.4) | 2 (13.3) | 5 (17.2) |
| Injection site reactions | 1 (7.1) | 4 (26.7) | 5 (17.2) |
| Immunoglobulin decreased | 1 (7.1) | 2 (13.3) | 3 (10.3) |
| Urinary tract infection | 1 (7.1) | 2 (13.3) | 3 (10.3) |
| Dizziness | 0 (0) | 2 (13.3) | 2 (6.9) |
| Blood glucose increased | 0 (0) | 2 (13.3) | 2 (6.9) |
| Hemorrhoids | 2 (14.3) | 0 (0) | 2 (6.9) |
| Natural killer cell count decreased | 0 (0) | 2 (13.3) | 2 (6.9) |
Abbreviations: ADR, adverse drug reaction; AE, adverse event; SADR, serious adverse drug reaction; SAE, serious adverse event; TEAE, treatment emergent adverse event.