Table 3.
Summary of AEs, SAEs and AESIs (mITT or safety population)*
| cSLE study | Pooled aSLE studies | |||
| Placebo (n=40) |
Belimumab 10 mg/kg intravenously (n=53) |
Placebo (n=1355) |
Belimumab 1, 4 and 10 mg/kg intravenously and 200 mg subcutaneously (n=2815) |
|
| Number of patients with ≥1 AE, n (%) | ||||
| AE | 33 (82.5) | 42 (79.2) | 1184 (87.4) | 2440 (86.7) |
| Treatment-related AE | 15 (37.5) | 19 (35.8) | 463 (34.2) | 1019 (36.2) |
| SAE | 14 (35.0) | 9 (17.0) | 230 (17.0) | 421 (15.0) |
| AE resulting in study agent discontinuation | 5 (12.5) | 3 (5.7) | 109 (8.0) | 184 (6.5) |
| Death | 1 (2.5) | 0 (0.0) | 6 (0.4) | 16 (0.6) |
| Number of patients with ≥1 AESI, n (%)† | ||||
| Infections‡ | 3 (7.5) | 7 (13.2) | 97 (7.2) | 173 (6.1) |
| Serious infections | 1 (2.5) | 1 (1.9) | 17 (1.3) | 40 (1.4) |
| All opportunistic infections§ | 0 (0.0) | 1 (1.9) | 92 (6.8) | 157 (5.6) |
| Serious opportunistic infections | 0 (0.0) | 0 (0.0) | 14 (1.0) | 25 (0.9) |
| Active tuberculosis | 0 (0.0) | 1 (1.9) | 5 (0.4) | 4 (0.1) |
| Serious active tuberculosis | 0 (0.0) | 0 (0.0) | 3 (0.2) | 3 (0.1) |
| All herpes zoster | 3 (7.5) | 5 (9.4) | 59 (4.4) | 106 (3.8) |
| Serious herpes zoster | 1 (2.5) | 1 (1.9) | 5 (0.4) | 15 (0.5) |
| Sepsis | 0 (0.0) | 0 (0.0) | 10 (0.7) | 20 (0.7) |
| Serious sepsis | 0 (0.0) | 0 (0.0) | 6 (0.4) | 18 (0.6) |
| Malignancies (including NMSC) | 0 (0.0) | 0 (0.0) | 3 (0.2) | 12 (0.4) |
| Solid tumour | 0 (0.0) | 0 (0.0) | 2 (0.1) | 8 (0.3) |
| Haematological | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Skin | 0 (0.0) | 0 (0.0) | 1 (<0.1) | 4 (0.1) |
| Malignancies (excluding NMSC) | 0 (0.0) | 0 (0.0) | 2 (0.1) | 8 (0.3) |
| Depression/suicide/self-injury | 4 (10.0) | 1 (1.9) | 92 (6.8) | 210 (7.5) |
| Serious depression | 1 (2.5) | 0 (0.0) | 2 (0.1) | 6 (0.2) |
| Serious suicide/self-injury | 2 (5.0) | 0 (0.0) | 4 (0.3) | 4 (0.1) |
| Post-infusion systemic reactions | 3 (7.5) | 4 (7.5) | 110 (8.1) | 286 (10.2) |
| Serious post-infusion systemic reactions/hypersensitivity | 0 (0.0) | 0 (0.0) | 2 (0.1) | 13 (0.5) |
*mITT population for PLUTO, BLISS-52, BLISS-76, LBSL02 and BLISS-SC, and safety population for BLISS-NEA and EMBRACE.
†AESI occurring in ≥1 patient in both treatment groups in either PLUTO or the pooled adult studies.
‡Infections of special interest only (opportunistic infections, herpes zoster, tuberculosis and sepsis).
§Per sponsor adjudication.
AE, adverse event; AESI, adverse events of special interest; aSLE, adult-onset systemic lupus erythematosus; cSLE, childhood-onset systemic lupus erythematosus; mITT, modified intention-to-treat; NMSC, non-melanoma skin cancer; SAE, serious adverse event.