Table 2.
TEAEs, serious AEs, and AESIs in AQP4–IgG–seropositive participants receiving inebilizumab for ⩾4 years.
| Event | Participants (n = 75) |
|---|---|
| TEAE, n (%) | |
| Any TEAE | 70 (93.3) |
| Related to inebilizumab | 29 (38.7) |
| Grade ⩾3 | 16 (21.3) |
| Leading to treatment discontinuation | 0 |
| Leading to dose interruption a | 4 (5.3) |
| Death | 0 |
| Serious b | 7 (9.3) |
| Serious b and related to inebilizumab | 2 (2.7) |
| AESI, n (%) | |
| Any AESI | 62 (82.7) |
| Infusion-related reaction | 11 (14.7) |
| Anaphylactic reaction | 0 |
| Hypersensitivity | 0 |
| Infection | 59 (78.7) |
| Hepatic function abnormality | 4 (5.3) |
| Cytopenia | 4 (5.3) |
| Opportunistic infection | 0 |
| Progressive multifocal leukoencephalopathy | 0 |
| Treatment-emergent AESI rate after inebilizumab, incidence per 100 PY (95% CI) | |
| Any AESI | 88.8 (79.1–99.3) |
| Infusion-related reaction | 13.9 (10.3–18.5) |
| Infection | 71.4 (62.7–80.9) |
| Treatment-emergent infection rate after inebilizumab, incidence per 100 PY (95% CI) | |
| Overall | 71.4 (62.7–80.9) |
| Year 1 | 112.0 (89.3–138.7) |
| Year 2 | 69.3 (51.8–90.9) |
| Year 3 | 56 (40.4–75.7) |
| Year 4 | 56 (40.4–75.7) |
AE: adverse event; AESI: adverse event of special interest; AQP4: aquaporin-4; Ig: immunoglobulin; PY: person-year; TEAE: treatment-emergent AE; CI: confidence interval.
Three dose interruptions were related to infusion-related reactions: one participant received a full dose in 101 minutes; one received a full dose in 92 minutes; and one received a partial dose for 18 minutes.
Serious AE criteria include death, life-threatening, required inpatient hospital stay, prolongation of existing hospital stay, persistent or significant disability/incapacity, important medical event, and congenital anomaly/birth defect in the offspring of the participant.