Table 2.
Summary of treatment-emergent adverse events and adverse events of special interest (open-label safety population, N=255)
| n (%) | ||
|---|---|---|
| Placebo-to-Belimumab Intravenous 10 mg/kg, N=123 | Belimumab-to-Belimumab Intravenous 10 mg/kg, N=132 | |
| ≥1 AE | 76 (62) | 92 (70) |
| AE by SOC occurring in ≥5% of patients in either treatment group a | ||
| Infections and infestations | 52 (42) | 64 (49) |
| Musculoskeletal and connective tissue disorders | 16 (13) | 16 (12) |
| Skin and subcutaneous tissue disorders | 10 (8) | 17 (13) |
| Gastrointestinal disorders | 11 (9) | 13 (10) |
| Respiratory, thoracic, and mediastinal disorders | 5 (4) | 15 (11) |
| Nervous system disorders | 7 (6) | 10 (8) |
| General disorders and administration site conditions | 8 (7) | 8 (6) |
| Eye disorders | 0 (0) | 8 (6) |
| ≥1 treatment-related AE | 25 (20) | 24 (18) |
| Treatment-related AE by SOC occurring in ≥5% of patients in either treatment group | ||
| Infections and infestations | 17 (14) | 17 (13) |
| ≥1 serious AE | 5 (4) | 10 (8) |
| Serious AE by SOC occurring in ≥5% of patients in either treatment group | ||
| Infections and infestations | 4 (3) | 7 (5) |
| ≥1 AE resulting in study treatment discontinuation | 1 (0.8) | 4 (3) |
| AEs of special interest | ||
| Malignancies | 0 (0) | 0 (0) |
| Postinfusion systemic reactionsb | 4 (3) | 5 (4) |
| Infections of special interest (opportunistic infections, herpes zoster, tuberculosis, sepsis)c | 2 (2) | 6 (5) |
| Serious | 0 (0) | 2 (2) |
| Depression (including mood disorders and anxiety)/suicide/ self-injuryc | 2 (2) | 4 (3)d |
| Death e | 1 (0.8) | 0 (0) |
AE, adverse event; SOC, system organ class.
Patients are counted only once per SOC.
No serious postinfusion systemic reactions were reported.
Per customized Medical Dictionary for Regulatory Activities query (version 22.0).
There was one serious AE of suicidal behavior in a patient diagnosed with an adjustment disorder that occurred 12 days after the first open-label infusion. This patient recovered and completed belimumab treatment throughout the open-label phase.
Occurred 85 days after the first open-label infusion at open-label day 0 and 8 days after the last infusion at open-label week 12. Death was associated with fatal serious AEs of multiple organ dysfunction syndrome, sepsis secondary to nosocomial pneumonia, and CKD. The adjudicated category of death was “SLE related.”