Belimumab add on improves renal response in lupus nephritis patients: NEJM
USA: The addition of belimumab to standard therapy improved renal outcomes in patients with lupus nephritis, according to a recent study in the New England Journal of Medicine.
Brad H. Rovin, Ohio State University, and colleagues aimed to determine the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide–azathioprine), in patients with active lupus nephritis.
For the purpose, the researchers conducted a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial at 107 sites in 21 countries. 448 patients were assigned to receive intravenous belimumab (at a dose of 10 mg per kilogram of body weight) -- belimumab group (n=224) or matching placebo (n=224), in addition to standard therapy.
The primary end point at week 104 was a primary efficacy renal response (a ratio of urinary protein to creatinine of ≤0.7, 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).
Key findings of the study include:
- At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6) and a complete renal response (30% vs. 20%; odds ratio, 1.7).
- The risk of a renal-related event or death was lower among patients who received belimumab than among those who received placebo (hazard ratio, 0.51).
- The safety profile of belimumab was consistent with that in previous trials.
"In this trial involving patients with active lupus nephritis, more patients who received belimumab plus standard therapy had a primary efficacy renal response than those who received standard therapy alone," concluded the authors.
"Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis," is published in the New England Journal of Medicine.