Both patients with newly diagnosed and relapsed active lupus nephritis (LN) benefit from belimumab in addition to standard treatment, according to new study findings presented at the American Society of Nephrology’s Kidney Week 2021.
In a post hoc analysis of the BLISS-LN randomized trial, belimumab treatment (10 mg/kg) led to a higher primary efficacy response rate (PERR) in relapsed (36.0% vs 22.7%) and newly diagnosed (46.6% vs 37.2%) patients, compared with placebo at week 104, Hans-Joachim Anders, MD, of University of Munich in Germany, reported. PERR was defined as a urinary protein to creatinine (UPCR) ratio of 0.7 or less; an estimated glomerular filtration rate (eGFR) no more than 20% below pre-flare value (or 60 mL/min/1.73 m2 or higher); and no need for rescue therapy.
Belimumab also produced higher rates of complete renal response (CRR) in relapsed (22.7% vs 10.7%) and newly diagnosed (33.8% vs 24.3%) patients, compared with placebo. Complete renal response was defined as a UPCR ratio of less than 0.5; eGFR no more than 10% below pre-flare value (or 90 mL/min/1.73 m2 or higher); and no need for rescue therapy.
Belimumab was associated with 2.3- and 3.1-fold increased odds of PERR and CRR, respectively, in the relapsed group and 1.4- and 1.5-fold increased odds of PERR and CRR, respectively, in the newly diagnosed group.
The time to LN flare from week 24 to 104 decreased 55% among relapsed patients and 49% among newly diagnosed patients treated with belimumab vs placebo.
The time to a kidney-related event or death over 104 weeks decreased 53% among relapsed patients and 45% among newly diagnosed patients treated with belimumab vs placebo.
“While the results of this analysis demonstrated benefit of belimumab irrespective of lupus nephritis status, a larger improvement was observed in achieving renal response in relapsed patients compared with newly diagnosed patients,” Dr Anders told attendees. “For prevention of kidney-related events or death and lupus nephritis flares, similar benefits of treatment with belimumab versus placebo were observed in both subgroups.”
This research was supported by GlaxoSmithKline. Please see the original reference for a full list of disclosures.
Anders HJ, Rovin BH, Zhao MH, et al. Effects of Belimumab (BEL) on renal outcomes in patients (pts) with relapsed and newly diagnosed active lupus nephritis (LN). Presented at: Kidney Week 2021, November 2-7, 2021. Presentation: SA-OR32.