Blisibimod Seen to Lower Urine Protein Levels in Patients with Renal Involvement in Phase 3 Trial
Results of a Phase 3 clinical trial of blisibimod, by Anthera Pharmaceuticals, found that treatment significantly reduces proteinuria — excess proteins in the urine — in patients with systemic lupus erythematous (SLE).
Like many B-cell mediated autoimmune diseases, lupus is associated with elevated levels of B-cell activating factor (BAFF). Blisibimod is a BAFF-targeting treatment that is currently being developed by Anthera.
Anthera presented data from the CHABLIS-SC1 trial (NCT01395745) at the American Society of Nephrology (ASN) 2017 Annual Meeting, running Oct 31–Nov 5 in New Orleans. The presentation was titled “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)”
CHABLIS-SC1 included 442 patients with active lupus who were randomized to receive a weekly subcutaneous (beneath the skin) dose of 200 mg of blisibimod, or placebo.
Among the participants, the renal subgroup included 135 patients who had a urinary protein to creatinine ratio (UPCR) of 5 mg/mg or above (i.e., those with proteinuria that is equivalent to or more than 0.5 g/day). The study did not include patients who had proteinuria above 6 g/day, or those with severe disease requiring immunosuppressive therapy.
Blisibimod was seen to have a significant effect in this subgroup. More than half (59.7%) of patients had a reduction of 50 percent or more in UPCR from baseline levels, compared to a 30.8 percent reduction among patients given placebo.
More treated patients (53.2%) also saw their urinary protein to creatinine ratio drop below 0.5 g/day than did those in the placebo group (30.8%).
The treatment did not have an effect on the glomerular filtration rate or serum creatinine, and with the exception of mild to moderate injection site reactions, no adverse events were reported as a result of treatment.
The researchers concluded that a “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.”
“This analysis of the CHABLIS-SC1 Phase 3 clinical study showed that treatment with blisibimod elicited clinically-meaningful decreases in urinary protein:creatinine ratio when administered for 1 year with concomitant standard-or-care medication to patients with systemic lupus erythematosus (SLE) with renal manifestations,” Kenneth Kalunian, a professor of medicine at the University of California, San Diego, and a study author, said in a press release.