The addition of voclosporin to mycophenolate mofetil and low-dose steroids for the treatment of lupus nephritis resulted in improved protein-to-creatinine ratio, according to research presented at the European Alliance of Associations for Rheumatology (EULAR) Congress 2022. 

“These data show that treatment with voclosporin can help patients with lupus nephritis successfully achieve urine protein creatinine ratio treatment targets as recommended by the [EULAR] and the European Renal Association (ERA) – a high bar to achieve and clinically meaningful,” Hans-Joachim Anders, MD, from the University of Munich said in a release about the study.

Voclosporin is a novel, structurally modified calcineurin inhibitor, which works as an immunosuppressant by inhibiting T-cell activation and cytokine production and promoting podocyte stability in the kidney. 

The pooled analysis of the AURA-LV and AURORA 1 trials included 268 patients who received 23.7 mg twice daily of voclosporin, mycophenolate mofetil and low-dose steroids. The control arm included 266 patients who received mycophenolate mofetil and steroids. 

EULAR/ERA treatment targets were defined as: 

• at least a 25% reduction in UPCR at 3 months;

• at least a 50% reduction in UPCRat 6 months; 

• a UPCR of 0.7 mg/mg or less at 12 months; and 

• a steroid dose 7.5 mg/day or less at 3, 6, and 12 months.

Anders and colleagues noted that at 3 months, 78.4% of patients in the voclosporin arm achieved at least a 25% reduction in UPCR compared with 62.4% in the control arm (OR = 2.25; 95% CI CI, 1.52-3.33; P < .0001). The percentage of patients achieving a reduction of 50% or more at 6 months was also significantly greater in the drug arm at 66% compared to 47% (OR = 2.24; CI 1.57-3.21; P < .0001). After 1 year of treatment, 56.2% of patients in the drug arm achieved a UPCR of 0.7mg/mg or less compared with 33.1% (OR = 2.52; CI 1.75-3.63; P < .0001). 

The study had a protocol-defined target dose for steroids of 2.5 mg/day by week 16. At 3 and 6 months, Anders and colleagues noted over 90% of patients in both groups achieved the recommended dose. At 12 months,  89.6% of patients in the voclosporin arm and 82.8% in the control arm reached the recommended dose. 

Overall, 37.3% of patients in the voclosporin arm achieved all EULAR/ERA treatment targets compared to 23.3% in the control group (OR 2.11; CI 1.43-3.10; P = .0001). 

Serious adverse events were reported in 21% of patients in both arms. The most common adverse reactions included decreased glomerular filtration rate, hypertension, diarrhea, and headache. 

“We are thrilled to see voclosporin has met the [EULAR/ERA’s] guidelines indicated for urine protein creatinine ratio treatment targets,” Neil Solomons, MD, chief medical officer at Aurinia, said in the release. “We’ve already demonstrated the many benefits of treatment with voclosporin for patients with lupus nephritis through our studies at Aurinia, and analyses such as this one builds additional evidence and confidence for rheumatologists and nephrologists to offer patients this important treatment option.” 

Disclosures: Solomons and some of the authors are employees of Aurinia. See full study for details. 

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