Voclosporin in Black Patients With Lupus Nephritis: AURORA Studies

Black patients with lupus nephritis commonly have more severe disease, are often refractory to treatment, and experience worse long-term outcomes. Treatment with voclosporin in conjunction with low-dose glucocorticoids and mycophenolate mofetil (MMF) has been shown to have significant benefit across ancestries and classes of lupus nephritis.

During a poster session at the American Society of Nephrology Kidney Week 2023, Gabriel Contreras and colleagues reported on outcomes of up to 3 years of follow-up in patients identifying as Black who were treated with voclosporin during the phase 3 AURORA studies. The poster was titled Long-term Safety and Efficacy of Voclosporin in Black Patients With Lupus Nephritis.

Inclusion criteria for the parent AURORA 1 study were biopsy-proven lupus nephritis, urine protein creatinine ratio (UPCR) ≥15 g/g (≥2 g/g for Class V), and estimated glomerular filtration rate (eGFR) >45 mL/min/1.73 m². Participants who completed AURORA 1 were eligible to enter AURORA 2, a continuation study on the same blinded therapy of voclosporin or placebo in combination with MMF and glucocorticoids for an additional 2 years.

Study outcomes of programmed complete renal response (CRR; UPCR ≤0.5 g/g, stable eGFR, low-dose steroids, and no rescue medication), partial renal response (PRR; reduction in UPCR of ≥50% from baseline), and safety were assessed in a subgroup of patients who self-identified as Black or mixed Black.

In the voclosporin arm of AURORA 1, 14.5% of participants (26/179) self-identified as Black or mixed Black; in the control arm, 10.6% of participants (19/178) self-identified as Black or mixed Black. The two arms were similar in baseline characteristics. At 1 year, CRR rates numerically favored voclosporin (46.2% vs 15.8%; odds ratio [OR], 3.92; P=.0597). PRR rates also favored voclosporin at 1 year (69.2% vs 47.4%; OR, 2.62; P=.1422).

A total of 18 patients in the voclosporin arm and seven in the control arm in the Black subgroup continued into AURORA 2. At 3 years, response rates continued to numerically favor voclosporin (CRR, 44.4% vs 14.3%; OR, 4.17; P=.2276 and PRR, 66.7% vs 42.9%; OR, 1.67; P=.6094).

Over the 3-year period, there were greater reductions in mean UPCR in the voclosporin arm (change from baseline, –3.4 g/g vs –1.5 g/g; P=.0349). Over the 3 years of treatment, mean eGFR remained stable and in the normal range.

“Black patients treated with a voclosporin-based regimen achieved higher rates of renal response than patients treated with MMF and glucocorticoids alone,” the researchers said. “For patients entering the continuation study, the response was largely durable for up to 3 years.”

Source: Contreras G, Baker MG, Hodge LS, Yap E. Long-term safety and efficacy of voclosporin in Black patients with lupus nephritis. SA-PO876. Abstract of a poster presented at the American Society of Nephrology Kidney Week 2023; November 4, 2023; Philadelphia, Pennsylvania. Funding was provided by Aurinia Pharmaceuticals Inc.