Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis
- PMID: 32937045
- DOI: 10.1056/NEJMoa2001180
Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis
Abstract
Background: In adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine), are unknown.
Methods: In a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial conducted at 107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive intravenous belimumab (at a dose of 10 mg per kilogram of body weight) or matching placebo, 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), and the major secondary end point was a complete renal response (a ratio of urinary protein to creatinine of <0.5, 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). The time to a renal-related event or death was assessed.
Results: A total of 448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group). 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; 95% confidence interval [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 among patients who received belimumab than among those who received placebo (hazard ratio, 0.51; 95% CI, 0.34 to 0.77; P = 0.001). The safety profile of belimumab was consistent with that in previous trials.
Conclusions: 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. (Funded by GlaxoSmithKline; BLISS-LN ClinicalTrials.gov number, NCT01639339.).
Copyright © 2020 Massachusetts Medical Society.
Comment in
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Belimumab as Add-on Therapy in Lupus Nephritis.N Engl J Med. 2020 Sep 17;383(12):1184-1185. doi: 10.1056/NEJMe2027516. N Engl J Med. 2020. PMID: 32937052 No abstract available.
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Adding belimumab improves lupus nephritis.Nat Rev Rheumatol. 2020 Nov;16(11):601. doi: 10.1038/s41584-020-00520-y. Nat Rev Rheumatol. 2020. PMID: 32994586 No abstract available.
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Belimumab in lupus nephritis.Nat Rev Nephrol. 2020 Dec;16(12):702. doi: 10.1038/s41581-020-00362-7. Nat Rev Nephrol. 2020. PMID: 33024302 No abstract available.
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Belimumab in Lupus Nephritis.N Engl J Med. 2021 Jan 14;384(2):187. doi: 10.1056/NEJMc2032520. N Engl J Med. 2021. PMID: 33497557 No abstract available.
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Belimumab in Lupus Nephritis.N Engl J Med. 2021 Jan 14;384(2):187-188. doi: 10.1056/NEJMc2032520. N Engl J Med. 2021. PMID: 33497558 No abstract available.
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Are new treatments for lupus nephritis on the horizon?Kidney Int. 2021 Feb;99(2):298-300. doi: 10.1016/j.kint.2020.11.020. Kidney Int. 2021. PMID: 33509347 No abstract available.
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