LAUSR

Recently, two different studies1 2 applied the criteria of the Lupus Low Disease Activity State (LLDAS)3 to the data sets of the BLISS-524 and BLISS-765 phase III trials of belimumab. The studies reported similar LLDAS attainment frequencies at key time points; however, not identical. We herein discuss possible explanations in order to guide future usage of the LLDAS. In the study by Parodis et al ,1 LLDAS at week 52 was achieved by 10.0% of the patients in BLISS-52 and 7.1% in BLISS-76, with a greater percentage within patients who received belimumab 10 mg/kg compared with patients who received placebo in BLISS-52 (11.9% vs 6.2%; p=0.030), but not in BLISS-76 (8.3% vs 6.4%; p=0.473). In the study by Oon et al ,2 LLDAS at week 52 was attained by 12.5% and 14.4% in the belimumab 10 mg/kg arm versus 5.8% and 7.8% in the placebo arm in BLISS-52 (p=0.02) and BLISS-76 (p=0.04), respectively. The small-scale differences …