Table 2.
Major characteristics of included studies
| Study | Treatment (intravenous) | N | Mean age (SD) years | SELENA-SLEDAI at entry | Geographical distribution of patients | Ethnic make-up of trial participants |
Number and location of Study Centres | ||
|---|---|---|---|---|---|---|---|---|---|
| L02 2006 Phase II 52 week | Bel 1 mg/kg | 114 | 42 (11) | >4 points | USA (98%), | Caucasian | NR | 69.9% | 59 in N America |
| Bel 4 mg/kg | 111 | Canada (2%) | African American | NR | 24.7% | ||||
| Bel 10 mg/kg | 111 | Latino | NR | 18.5% | |||||
| Placebo | 113 | ||||||||
| BLISS-52 2009 Phase III 52 week | Bel 1 mg/kg | 288 | 36 (11) | >6 points | Latin America (50%), | Caucasian | 229 | 27% | 90 in Pacific Asia. |
| Bel 10 mg/kg | 290 | Asia (38%), | Asian | 327 | 38% | 11 in S America and E Europe | |||
| Placebo | 287 | E Europe and Australia (13%) | Black/African Am | 30 | 4% | ||||
| Alaskan Nat/Am Indian | 279 | 32% | |||||||
| Nat Hawaiian/Pacific Islander | 0 | 0% | |||||||
| Multiracial | 5 | 1% | |||||||
| BLISS-76 2009 Phase III 76 week | Bel 1 mg/kg | 271 | 40 (12) | >6 points | USA and Canada (53%), | Caucasian | 569 | 70% | 136 in |
| Bel 10 mg/kg | 273 | W Europe (25%) | Asian | 28 | 3% | N America and Europe | |||
| Placebo | 275 | E Europe (11%) | Black/African Am | 118 | 14% | ||||
| Latin America (11%) | Alaskan Nat/Am Indian | 103 | 13% | ||||||
| Nat Hawaiian/Pacific Islander | 1 | 0% | |||||||
| Multiracial | 8 | 1% | |||||||
NR, not reported; SELENA-SLEDAI, Safety of Estrogen in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index.