Merrill JT, et al. - This trial was conducted in order to assess the effectiveness and safety of blisibimod (a BAFF inhibitor) in a population of patients with systemic lupus erythematosus (SLE) enriched for high disease activity. Findings suggested good tolerability of blisibimod. Upper respiratory tract infection, urinary tract infection, injection site erythema/reaction and diarrhea were the most common adverse event. Blisibimod was noted to be related to successful steroid reduction, decreased proteinuria and biomarker responses, however, the SLE Responder Index-6 (SRI-6) endpoint was not met.

Methods

• Authors randomised 442 patients having SLE with antinuclear antibodies or anti-dsDNA and Safety of Estrogen in Lupus Erythematosus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥10 on standard-of-care medications to receive weekly subcutaneous blisibimod (200 mg) or placebo.
• From week 8 corticosteroid taper was encouraged.
• Herein the primary end point was the week 52 SLE Responder Index-6 (SRI-6).

Results

• As per the data, the SRI-6 primary end point was not met.
• Researchers noted a statistically significant steroid-sparing impact, and corticosteroid taper was achieved by significantly more blisibimod-treated subjects.
• In subjects who achieved a concomitant decrease in corticosteroid dose from baseline, an increased blisibimod treatment effect on SRI-6 was observed.
• Findings suggested that in subjects with baseline urinary protein:creatinine ratio (UPCR) ≥56.5 mg/mmol, notably higher proportions of blisibimod subjects achieved >50% reduction in UPCR and/or UPCR <56.5 mg/mmol.
• With blisibimod, reductions in SLE autoantibodies and B cells, and increases in complement C3 and C4 were noted.
• There was a good tolerability of blisibimod.
• Upper respiratory tract infection, urinary tract infection, injection site erythema/reaction and diarrhoea were the most common adverse events.