Surgery News

Expression of BCRP in RA patients may indicate higher disease activity, predict resistance to DMARDs

September 13, 2015

Among patients who were positive for autoantibodies at baseline, significantly greater median percent reductions in autoantibodies were observed in the belimumab treatment groups by Week 52, vs. placebo, including: reductions in anti-dsDNA of 37.6% for belimumab 10 mg/kg, 35.1% for belimumab 1 mg/kg, and 12.3% for placebo (p<0.001 for both doses); reductions in anti-Smith of 56.3% for belimumab 10 mg/kg, 47.0% for belimumab 1 mg/kg, and 29.6% for placebo> A significantly greater percentage of belimumab-treated patients with hypergammaglobulinemia at baseline achieved normalization of IgG at Week 52 (p<0.05). Significantly greater median percent reductions in immunoglobulins were observed in the belimumab treatment groups by Week 52 (with p<0.0001 for both belimumab doses, vs. placebo), including: reductions in IgG of 15.6% for belimumab 10 mg/kg, 14.1% for belimumab 1 mg/kg, and 3.6% for placebo; reductions in IgM of 30.0% for belimumab 10 mg/kg, 28.5% for belimumab 1 mg/kg, and 3.2%% for placebo; and reductions in IgA of 16.0% for belimumab 10 mg/kg, 16.8% for belimumab 1 mg/kg, and 2.7% for placebo. Among patients with low C3 and C4 complement at baseline, significantly greater median percent increases were observed among patients in the belimumab treatment groups vs. the placebo group, with increases observed by Weeks 4-8 that were sustained or increased through Week 52. At Week 52, the median percent increase from baseline in C3 complement was 16.3% for belimumab 10 mg/kg, 10.1% for belimumab 1 mg/kg, and 2.1% for placebo (p<0.0001 and>

Additional BLISS-52 Efficacy Data

Disease activity and flares: The EULAR presentation included BLISS-52 data previously presented at ACR, which demonstrated that belimumab 10 mg/kg also significantly reduced disease activity as measured by SELENA SLEDAI scores and Physicians Global Assessment (PGA); significantly delayed time to severe flare and significantly reduced the risk of 1 BILAG A (severe) organ flare or more than 1 BILAG B (moderate) organ flare. Fatigue and health-related quality of life (HRQOL): The EULAR presentation included previously presented BLISS-52 data, which demonstrated that, in both belimumab treatment groups vs. placebo, significantly greater improvements were achieved by Week 52 in FACIT-Fatigue scores and in SF-36 Health-Related Quality-of-Life Physical Component Summary (PCS), Physical Functioning and Bodily Pain scores.

Safety

In BLISS-52, belimumab was generally well tolerated, with rates of adverse events overall, serious and/or severe adverse events, all infections, serious and/or severe infections, and discontinuations due to adverse events comparable between treatment groups receiving belimumab plus standard of care and the treatment group receiving placebo plus standard of care. Serious and/or severe adverse events were reported in 18.5% of patients on belimumab and 16.7% of patients on placebo. Infections were reported in 67.6% of patients on belimumab and 63.8%% of patients on placebo. Serious and/or severe infections were reported in 6.2% of patients on belimumab and 6.3% of patients on placebo. Serious and/or severe infusion reactions were reported in 1.6% of patients on belimumab and 0.3% of patients on placebo. Discontinuations due to adverse events were 5.4% in the belimumab treatment groups and 6.6% in the placebo treatment group. No malignancies were reported. A total of 9 deaths were reported in the study: 4, 2, and 3 in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively.

SOURCE Human Genome Sciences, Inc.