FDA Approvals: Lupus Nephritis

Background: The U.S. approval of voclosporin was based on multi-national clinical trials, including the AURORA-1 phase 3 and AURA-LV phase 2 studies.6-8 Voclosporin’s label carries a boxed warning, stating that patients taking the treatment may have an increased risk for developing

lymphomas and other malignancies, particularly of the skin, and serious infections. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any

specific agent.⁵

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Mok CC, Kwok RC, Yip PS. Effect of renal disease on the standardized mortality ratio and life expectancy of patients with systemic lupus erythematosus. Arthritis Rheum. 2013

   Aug;65(8):2154–2160.

2. FDA approves GSK’s Benlysta as the first medicine for adult patients with active lupus nephritis in the U.S. [news release] GlaxoSmithKline plc. 2021 Dec 17.
3. Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med. 2020 Sep 17;383(12):1117–1128.
4. FDA Approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis. [news release] Aurinia Pharmaceuticals Inc. 2021 Jan 22.
5. Highlights of prescribing information: Lupkynis (voclosporin) capsules. U.S. Food & Drug Administration. 2021 Jan 22. https://tinyurl.com/yg6mdab6.
6. Ginzler EM, Kaplan J, Lisk L, et al. Integrated efficacy of the AURORA 1 and AURA-LV trials

   confirms voclosporin rapid proteinurea reduction in the presence of low-dose steroids [abstract 1843]. Arthritis Rheumatol. 2020 Oct;72(suppl 10).

7. Rovin BH, Solomons N, Pendergraft WF 3rd, et al. A randomized, controlled double-blind study

   comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney Int. 2019 Jan;95(1):219–231.

8. Arriens C, Polyakova S, Adzerikho I, et al. Aurora phase 3 study demonstrates voclosporin statistical superiority over standard of care in lupus nephritis (LN) [abstract OP0277]. Ann Rheum Dis. 2020;79(Suppl 1):172–173.

Excerpted from https://www.therheumatologist.org/article/fda-approvesbelimumab-voclosporin-for-lupus-nephritis.