Summary of TEAEs
| . | Riliprubart (n [%]) . | |
|---|---|---|
| 15 mg/kg IV (n = 6) . | 30 mg/kg IV (n = 6) . | |
| Patients with any TEAE | 6 (100) | 5 (83.3) |
| Patients with any severe TEAE | 1 (16.7)∗ | 0 |
| Patients with any treatment-emergent SAE | 0 | 0 |
| Patients with any TEAE leading to death | 0 | 0 |
| Patients with any TEAE leading to permanent study intervention discontinuation | 0 | 0 |
| Patients with any TEAE leading to permanent study discontinuation | 0 | 0 |
| Patients with any TEAE of special interest | 2 (33.3)† | 0 |
| . | Riliprubart (n [%]) . | |
|---|---|---|
| 15 mg/kg IV (n = 6) . | 30 mg/kg IV (n = 6) . | |
| Patients with any TEAE | 6 (100) | 5 (83.3) |
| Patients with any severe TEAE | 1 (16.7)∗ | 0 |
| Patients with any treatment-emergent SAE | 0 | 0 |
| Patients with any TEAE leading to death | 0 | 0 |
| Patients with any TEAE leading to permanent study intervention discontinuation | 0 | 0 |
| Patients with any TEAE leading to permanent study discontinuation | 0 | 0 |
| Patients with any TEAE of special interest | 2 (33.3)† | 0 |
Both events were assessed by the investigator as not drug-related.
SAE, serious AE.
Pretreatment severe AE (grade 3) of hemolytic anemia that began prior to riliprubart administration and was ongoing during the treatment period;
One patient reported 2 episodes of polyarthritis; the first episode occurred during the screening period and the second episode on day 34 (grade 2, worsening from baseline symptoms); 1 patient reported a positive anti–dsDNA laboratory test result at baseline prior to administration of riliprubart, remaining positive throughout the study; the patient had no clinical signs of SLE.