More serious adverse events occurred in patients treated with voclosporin (both doses). Infections and infestations occurred in 12.4% (n=11) of patients who received low-dose voclosporin, in 13.6% (n=12) of patients who received high-dose voclosporin, and in 8% (n=7) of patients who received placebo. !irteen patients died during the study. More deaths occurred in patients who received low-dose voclosporin (n=10; 11.2%) than among patients who received high-dose voclosporin (n=2; 2.3%) and among those patients who received placebo (n=1; 1.1%).
The efficacy results from the AURORA 1 phase 3 study showed that patients treated with voclosporin were consistent with those seen in the AURA-LV study.9 The data showed a renal response in 40.8% of patients treated with voclosporin compared with 22.5% in the control arm, which was statistically significant (P<0.001). The overall incidence of serious adverse events was similar in both groups (voclosporin: 20.8%; control: 21.3%). Infections were the most commonly reported adverse event, at 10.1% with voclosporin and 11.2% in controls. The overall study mortality was low, with one death in the voclosporin arm and five deaths in the control arm.
The most common adverse effects, which occurred in at least 3% of voclosporin-treated patients, were abdominal pain (5%), alopecia (6%), anemia (12%), cough (11%), decreased appetite (3%), diarrhea (19%), dyspepsia (6%), fatigue (4%), headache (15%), hypertension (19% vs. 9% for placebo), mouth ulceration (4%), tremor (3%) and urinary tract infection (10%).5 Adverse effects of particular note included acute kidney injury (3% vs. 1% for placebo), decreased glomerular filtration rate (26% vs. 9% for placebo) and renal impairment (6% vs. 3% for placebo).
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.6
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
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- News release: FDA Approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis. Aurinia Pharmaceuticals Inc. 2021 Jan 22.
- Highlights of prescribing information: Lupkynis (voclosporin) capsules. U.S. Food & Drug Administration. 2021 Jan 22. https://tinyurl.com/yg6mdab6.
- 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).
- 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.
- 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.
