Table 2.

Clinical studies of epratuzumab in SLE

Study	Study design	Duration	Effectiveness	Safety
Initial clinical trial [34]	Phase II open-label, non-randomized single centre study; n = 14; 4 × 360 mg m−2 every other week with analgetic/antihistamine premedication; low-dose corticosteroids permitted during study	32 weeks	B-cell depletion (median of 35% at 18 weeks) in 11/11 pts within 6–32 weeks; Total BILAG score decreased by ≥50% in 14/14 patients at some point within 6–32 weeks	Well tolerated; five infections, six mild transient infusional reactions
SL0003 and SL0004 [35, 41–43]	Phase III randomized placebo controlled multicentre studies; n = 90; 360 mg m−2 (n = 42) or 720 mg m−2 (n = 11) at weeks 0,1,2 and 3; subsequently two infusions 1 week apart every 12 weeks; up to four treatment cycles; placebo (n = 37); antimalarials/immunosuppresives unchanged; corticosteroids increased at baseline, tapering initiated at week 4	48 weeks	B-cell depletion: 35% (360 mg m−2), 71,5% (720 mg m−2), 19% (placebo) at week 24; significantly greater reductions of total BILAG scores vs. placebo at 4–48 weeks	Well tolerated; nine vs. eight (placebo) serious infections; nine vs. seven mild infusion reactions
NCT00383513 [44]	Phase III open-label multicentre re-treatment trial for patients previously randomized into SL0003 and SL0004 trials; n = 30 (estimated); 360 mg m−2; two consecutive weekly administrations followed by 12 week maintenance cycles	4 years (time frame for primary and secondary outcome measures)	Not published (estimated study completion date: 2014)	Not published

BILAG, British Isles Lupus Assessment Group.