The efficacy and safety of belimumab is maintained for at least an additional 6 months beyond 2 years in patients with active lupus nephritis, investigators report.
In an open-label extension of the BLISS-LN trial, all eligible patients received 10 mg/kg intravenous belimumab for 28 weeks, including 132 previously receiving belimumab and 123 previously receiving placebo. No medications were prohibited.
The proportion of patients achieving a primary efficacy renal response (PERR), one of the study’s endpoints, increased from 60% to 67% in the group switched from placebo and from 70% to 75% in the group continuing belimumab, Richard Furie, MD, of Northwell Health in Great Neck, New York, and colleagues reported in the Clinical Journal of the American Society of Nephrology. Dr Furie’s team defined PERR as a urine protein-creatinine ratio (UPCR) of 0.7 or less, an estimated glomerular filtration rate (eGFR) no more than 20% below the open-label baseline value or 60 mL/min/1.73 m2 or more.
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In addition, the proportion of patients achieving a complete renal response, another endpoint, increased from 36% to 48% in the switched group and from 48% to 62% in the continuation group, the investigators reported. They defined complete renal response as a UPCR less than 0.5, eGFR no more than 10% below open-label baseline value, or 90 mL/min/1.73 m2 or higher.
UPCR and eGFR values did not differ at 28 weeks compared with baseline.
Adverse events and serious adverse events were experienced by 62% and 4% of switched patients, respectively, and by 70% and 8% of continuation patients, respectively. One death occurred in the switched group.
According to the investigators, data suggest that continuation or initiation of belimumab in addition to standard therapy at 104 weeks can be beneficial in patients with lupus nephritis with no new safety signals.
Disclosure: This research was supported by GlaxoSmithKline. Please see the original reference for a full list of disclosures.
Reference
Furie R, Rovin BH, Houssiau F, et al. Safety and efficacy of belimumab in patients with lupus nephritis: open-label extension of BLISS-LN study. Clin J Am Soc Nephrol. 17(11): 1620-1630. doi:10.2215/CJN.02520322
