Intravenous Treatment Plus Standard Therapy Yields Renal Response in Patients With Lupus Nephritis
More patients with active lupus nephritis achieved a primary efficacy renal response when receiving intravenous belimumab plus standard therapy compared to patients receiving standard therapy alone.
Researchers conducted a phase 3 trial among 448 patients with biopsy-proven lupus nephritis in 21 countries. Findings were published in The New England Journal of Medicine.
Participants were randomized to receive either intravenous belimumab at a dosage of 10 mg/kg or the same dosage of placebo, plus up to 3 g standard therapy—either mycophenolate mofetil or cyclophosphamide-azathioprine. Belimumab is a recombinant igG1 monoclonal antibody that inhibits B-cell activation.
Significantly more patients in the belimumab group had a primary efficacy renal response (43% vs 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P=.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P=.02) at two years.
Primary efficacy renal response was defined as “a ratio of urinary protein to creatinine of ≤.7, an estimated glomerular filtration rate (eGFR) that was no worse than 20% below the value before the renal flare (pre-flare value) or ≥60 mL per minute per 1.73 m2 of body surface area, and no use of rescue therapy.”
Complete renal response was defined as “a ratio of urinary protein to creatinine of <.5, an eGFR that was no worse than 10% below the pre-flare value or ≥90 mL per minute per 1.73 m2, and no use of rescue therapy.”
Participants who received belimumab also had a lower risk of renal-related adverse events or death compared to those in the placebo group (hazard ratio, 0.51; 95% CI, 0.34 to 0.77; P=.001).
No new safety signals for belimumab were found.
Reference:
Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med. 2021;383(12):1117-1128. doi:10.1056/NEJMoa2001180
