Abstract: TH-OR069

Effects of Blisibimod, a Selective Inhibitor of B-Cell Activating Factor, on Urinary Protein:Creatinine Ratio (UPCR) in Subjects with Renal Manifestations of Systemic Lupus Erythematosus (SLE)

Session Information

Category: Glomerular

  • 1005 Clinical Glomerular Disorders

Authors

  • Merrill, Joan T, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
  • Martin, Renee, Anthera Pharmaceuticals, Inc., Hayward, California, United States
  • Shanahan, William, Anthera Pharmaceuticals, Inc., Hayward, California, United States
  • Kalunian, Kenneth, UCSD, La Jolla, California, United States
  • Wofsy, David, University of California, San Francisco, California, United States
Background

The CHABLIS-SC1 trial (NCT01395745) was a Phase 3 trial of blisibimod in 442 patients with active systemic lupus, 135 of whom had UPCR≥0.5 mg/mg at study entry.

Methods

Subjects in the CHABLIS-SC1 trial were randomized to receive weekly subcutaneous blisibimod (200 mg) or placebo. All subjects had anti-nuclear or anti-dsDNA antibodies and SLEDAI score ≥10 on standard of care medications. Patients with renal manifestations were eligible unless proteinuria exceeded 6 g/24hour or disease severity was likely to require escalation of immunosuppressive therapy. This report evaluates the effects of blisibimod in the subgroup of subjects with baseline UPCR≥0.5 mg/mg.

Results

In the renal subgroup, greater decreases in UPCR from baseline were observed in the blisibimod arm (Figure). Significantly more subjects who received blisibimod achieved >50% reduction in UPCR from baseline (59.7% vs 30.8%, p=0.006). A higher proportion also achieved UPCR<0.5 (53.2% and 30.8%, p=0.021). No treatment effects were noted on eGFR and serum creatinine, which typically were within normal ranges throughout the trial.
Across all 442 enrolled subjects, adverse events were balanced between treatment arms excepting mild or moderate injection site erythema and injection site reaction which occurred more frequently with blisibimod.

Conclusion

The reduction in proteinuria in SLE subjects with clinical evidence of nephritis suggests that blisibimod may have therapeutic potential in lupus nephritis and, perhaps, other B-cell-associated renal diseases.

Treatment Effects on UPCR

Funding

  • Commercial Support