medwireNews: Adding belimumab to standard therapy improves renal outcomes among patients with lupus nephritis, indicate findings from the BLISS-LN trial presented at the EULAR 2020 E-Congress.
This is “the largest lupus nephritis study performed to date,” showing that “the addition of belimumab safely provided benefit beyond that of standard therapy alone,” said lead investigator Richard Furie (Northwell Health, Great Neck, New York, USA).
Furie explained that all patients received standard treatment comprising induction therapy with high-dose corticosteroids plus either cyclophosphamide or mycophenolate mofetil, followed by maintenance therapy with low-dose corticosteroids plus azathioprine or mycophenolate mofetil. Participants were randomly assigned to receive once-monthly intravenous treatment with add-on belimumab 10 mg/kg or placebo.
At the 104-week follow-up, 43.0% of the 223 participants in the belimumab group achieved the primary endpoint of Primary Efficacy Renal Response (PERR), defined as urine protein:creatinine ratio (uPCR) of 0.7 or lower, estimated glomerular filtration rate (eGFR) no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73m2, and no treatment failure.
This was significantly higher than the PERR rate of 32.3% for the 223 patients given placebo, with a significant odds ratio (OR) of 1.55.
The proportion of patients achieving a Complete Renal Response (uPCR<0.5, eGFR no worse than 10% below the pre-flare value or ≥90 mL/min per 1.73m2, and no treatment failure) at week 104 was also significantly higher in the belimumab than the placebo arm (30.0 vs 19.7%; OR=1.74), as was the PERR rate at week 52 (46.6 vs 35.4%; OR=1.59). A significantly lower proportion of patients in the belimumab group experienced renal-related events or death (15.7 vs 28.3%).
Furie reported that “there were no outstanding safety issues” in the BLISS-LN trial, “despite the fact that belimumab was added to background therapy consisting of mycophenolate or cyclophosphamide along with sterioids.”
A total of 54.9% and 53.1% of participants in the belimumab and placebo groups, respectively, experienced treatment-related adverse events (AEs), and the corresponding rates of treatment-related serious AEs were 10.3% and 11.2%.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group