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. 2012 Sep;13(9):731–744. doi: 10.1631/jzus.B1200057

Table 2.

Characters of 2 RCT studies

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