Belimumab, standard therapy improves outcomes in East Asian patients with lupus nephritis
Click Here to Manage Email Alerts
Belimumab treatment and standard therapy caused greater kidney outcomes among East Asian patients with lupus nephritis compared with standard therapy alone.
Further, researchers reported the combined treatment was “safe and effective.”
“Lupus nephritis is a severe complication of the kidneys in patients with the autoimmune disease systemic lupus erythematosus. Belimumab is used in combination with standard therapy for treatment of patients with lupus nephritis,” Xueqing Yu, MD, PhD, from Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences in China, and colleagues wrote. “As data on belimumab treatment of East Asian patients with lupus nephritis are limited, we assessed the efficacy and safety of belimumab in a subgroup of East Asian patients from the BLISS-LN, a randomized controlled trial.”
In a phase 3, placebo controlled, randomized trial, researchers observed 142 adult patients with active lupus nephritis from mainland China, Hong Kong, South Korea and Taiwan between July 2012 and July 2019.
All patients were randomized (1:1) to receive intravenous belimumab (Benlysta, GlaxoSmithKline) 10 mg/kg (n = 74) or placebo (n = 68), in addition to standard therapy (oral glucocorticoids and either cyclophosphamide for induction followed by azathioprine for maintenance, or mycophenolate mofetil for both induction and maintenance).
During induction, and at the researchers’ discretion, one to three intravenous pulses of methylprednisolone at 500 to 1,000 mg each could be administered. Patients received treatment on days 1, 15 and 29, and then for every 28 days up to week 100.
Researchers considered the Primary Efficacy Renal Response (PERR) of at least 0.7 and an eGFR of 60 mL/min/1.73 m2 or greater at week 104 to be the primary outcome of the trial.
Using a logistic regression model, researchers determined PEER and Complete Renal Responses among patients. Additionally, researchers used a multivariable Cox proportional-hazards regression model to measure time to a renal-related event or death.
Overall, 62.2% of those who received belimumab achieved PERR by week 52 compared with 36.8% of those who received placebo; at week 104, this difference was maintained (52.7% vs. 36.8%). Therefore, belimumab did reduce the risk of a renal-related event or death compared with placebo at any time.
“Our subgroup analysis of East Asian patients participating in the BLISS-LN study demonstrated that the addition of belimumab to standard therapy improved kidney responses compared with standard therapy alone. Efficacy results in the East Asian subgroup were consistent with those of the overall population of the BLISS-LN study,” Yu and colleagues wrote. They added, “Treatment with belimumab resulted in early and sustained improvements in renal outcomes in the East Asian population, with no new safety concerns.”
Collapse
Read more about
Click Here to Manage Email Alerts