Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.
Timeline
- Start
- 2012-07-12
- Primary completion
- 2019-07-25
- Completion
- 2020-03-12
Outcome
Met primary endpoint
registry NUMBER Placebo: 32.3 Percentage of participants NUMBER Belimumab 10 mg/kg: 43.0 Percentage of participants NCT01639339 ↗
registry analysis (other test); Placebo vs Belimumab 10 mg/kg; p = 0.0311; Odds Ratio (OR) 1.55 (95% CI 1.04 to 2.32) NCT01639339 ↗
release “The Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) study, involving 448 patients, met its primary endpoint” gsk.com ↗
release “The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients. The study met its primary endpoint” gsk.com ↗
Publications
- Furie R, Anders HJ, Bertsias G, Delgado A, Levy RA, Curtis P, O'Shea C, Tomlinson R, Rovin B. A post hoc analysis of BLISS-LN found Belimumab plus mycophenolate mofetil improves kidney outcomes versus placebo plus mycophenolate mofetil in active lupus nephritis. Kidney Int. 2026 May 21:S0085-2538(26)00397-2. doi: 10.1016/j.kint.2026.03.030. Online ahead of print.
- Anders HJ, Furie R, Malvar A, Zhao MH, Hiromura K, Weinmann-Menke J, Green Y, Jones-Leone A, Negrini D, Levy RA, Lightstone L, Tanaka Y, Rovin BH. Effect of belimumab on kidney-related outcomes in patients with lupus nephritis: post hoc subgroup analyses of the phase 3 BLISS-LN trial. Nephrol Dial Transplant. 2023 Nov 30;38(12):2733-2742. doi: 10.1093/ndt/gfad167.
- Sada K, Kurita N, Noma H, Matsuki T, Quasny H, Levy RA, Jones-Leone AR, Gairy K, Yajima N. MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT. Lupus Sci Med. 2022 Sep;9(1):e000746. doi: 10.1136/lupus-2022-000746.
- Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.
- Yu X, Chen N, Xue J, Mok CC, Bae SC, Peng X, Chen W, Ren H, Li X, Noppakun K, Gilbride JA, Green Y, Ji B, Liu C, Madan A, Okily M, Tang CH, Roth DA. Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population. Am J Kidney Dis. 2023 Mar;81(3):294-306.e1. doi: 10.1053/j.ajkd.2022.06.013. Epub 2022 Sep 2.
- Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.
- Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Azathioprine | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Methylprednisolone | Other / unclassified | 500 mg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 1000 mg | Intravenous |
| Background | Mycophenolate Sodium | Unknown | — | — |