FDA Approves Belimumab & Voclosporin for Lupus Nephritis

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.

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