Table 2.
Study | n e | n c | Subject | Mean age (year) | Follow-up period (week) | Treatment | Disease activity | Flare | Prednisone dose | Immunologic parameters | Adverse effect | Conclusion |
Explorer | 169 | 88 | Moderately to severely active extra renal SLE | 40.2 | 56 | Rituximab 1 000 mg 2 infusions at entry, again at 6 months, continue with prednisone dose | Low disease activity was achieved prior to Week 52 in 58 (66.0%) patients in the placebo group and in 127 (75.1%) patients in the rituximab group | No difference of median time to first moderate or severe flare and flare rate between two groups | The rate of prednisone rescue for A flare was similar | The decrease in rituximab was greater than that in the placebo group | Infusion related adverse effect similar in two groups. Four serum sickness adverse events in rituximab group | Explorer study did not meet the primary and secondary points, but suggested that rituximab may lessen severe flares as defined by BILAG A criteria |
Lunar | 72 | 72 | Class III/IV and active lupus nephritis | 30 | 52 | Rituximab on Days 1, 15, 168, and 182 | There were no statistically significant differences in the primary or clinical secondary end points | Not registered | Rituximab had a greater effect on levels of anti-dsDNA and complement at Week 52 | Serious adverse events were similar in two groups | Lunar did not show a statistically significant difference in primary or clinical secondary end points |
n e: number enrolled; n c: control number