Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis
In the phase 3 BLISS-LN trial, adding intravenous belimumab to standard therapy significantly improved renal responses in active lupus nephritis and lowered the risk of a renal-related event or death over 104 weeks.
Background
Lupus nephritis is a serious manifestation of systemic lupus erythematosus, and a substantial proportion of patients progress to kidney failure despite standard immunosuppression. Belimumab, an anti-BAFF monoclonal antibody already approved for SLE, had not been formally evaluated in active lupus nephritis when this trial was designed. BLISS-LN tested whether adding belimumab to standard therapy could improve renal outcomes.
Study design
This was a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial. A total of 448 adults with biopsy-proven, active lupus nephritis were randomized 1:1 to intravenous belimumab 10 mg per kilogram or matching placebo, each added to standard therapy with mycophenolate mofetil or cyclophosphamide followed by azathioprine. The primary endpoint was a primary efficacy renal response at week 104, with complete renal response as the major secondary endpoint.
Key findings
At week 104, significantly more patients receiving belimumab achieved a primary efficacy renal response (43% vs 32%; odds ratio 1.6, 95% CI 1.0 to 2.3; P=0.03) and a complete renal response (30% vs 20%; odds ratio 1.7, 95% CI 1.1 to 2.7; P=0.02). The risk of a renal-related event or death was lower with belimumab (hazard ratio 0.51, 95% CI 0.34 to 0.77; P=0.001). The safety profile was consistent with previous belimumab trials.
Clinical implications
These results supported the addition of belimumab to standard therapy as a means of improving renal response rates and reducing the risk of renal events in active lupus nephritis. Subsequent post hoc analyses suggested benefit was most apparent in patients with proliferative disease and lower baseline proteinuria, informing how the therapy is positioned within the treatment algorithm.
Category
Research
Source
N Engl J Med
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