Table 1.
Demographic characteristics, disease history, duration on study and reasons for discontinuation
| Patient # | Race | Disease historya | Prior therapy | Study drug treatment duration (Days) |
Reason for discontinuation | |||
|---|---|---|---|---|---|---|---|---|
| SLE (Months) |
LN (Months) |
Prior renal flare | MMF | CTX | ||||
| 2 | African American | 38 | < 1 | - | - | - | 148 | Leukocytoclastic vasculitis |
| 8 3 |
Caucasian | 46 | 38 | + | + | - | 85 | Study termination |
| African American | < 1 | < 1 | - | - | - | 29 |
H. influenzae pneumonia, IgG < 3 g/l |
|
| 5 | African American | 3 | < 1 | - | - | - | 230 | Study termination |
| 13 | African American | 52 | 52 | + | + | + | 31 | IgG < 3 g/lb |
| 14 | Asian | 32 | < 1 | + | + | + | 18 | IgG < 3 g/l |
Patients' mean (SD) height and weight were 169.3 (9.7) cm and 83.3 (20.8) kg, respectively. Patients #2 and #8 randomized to placebo; Patients #3, #5, #13 and#14 randomized to atacicept 150 mg subcutaneously twice weekly (4 weeks), then 150 mg weekly (48 weeks). aDisease history: time between SLE/LN diagnosis and consent. All patients had Class IV renal disease. bPatient #13 diagnosed with severe Legionella pneumonia on Day 34, 1 day after study discontinuation. CTX, cyclophosphamide; IgG, immunoglobulin G; LN, lupus nephritis; MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus.