A combination of voclosporin and standard therapy eliminated the inflamed-kidney condition lupus nephritis in twice as many patients as those who received standard care alone, according to a Phase 2b clinical trial.
The voclosporin combo also lengthened the time it took for lupus nephritis to re-emerge, its maker, Aurinia Pharmaceuticals, reported. Aurinia presented the updated findings at the European Congress of Rheumatology convention in Madrid, June 14-17.
Voclosporin inhibits calcineurin, a protein that activates T-cells. Inhibiting the immune-system cells stops the inflammation they trigger.
When combined with standard-of-care treatment, the drug can improve both near- and long-term outcomes in lupus nephritis patients.
Participants in the AURA-LV clinical trial (NCT02141672) were randomly assigned to a combo therapy. One group received a low dose of voclosporin twice a day and a standard-of-care therapy—mycophenolate mofetil and steroids. Another group received a high dose of voclosporin and standard of care, and a third a placebo and standard of care.
At 24 and 48 weeks, the kidney inflammation in the low-dose voclosporin group was much better than in the placebo arm. In fact, 49 percent of the low-dose group had no inflammation at 48 weeks—twice the 24 percent of the placebo group.
Patients whose inflammation was gone at week 24 remained inflammation-free at week 48, indicating that their response to low-dose voclosporin was durable.
The inflammation of those who took the high dose of voclosporin was also better at 48 weeks.
In addition, voclosporin prolonged the duration of patients’ remission to nearly twice the time seen in the placebo group. The measure they used to assess duration was the protein count in urine. The lower the count, the lower the rate of progression to chronic kidney disease.
Voclosporin was safe, and patients tolerated it well, researchers said. There were no reports of unexpected safety concerns.
“Not only have more patients on voclosporin achieved complete remission, but they have done so faster,” Dr. Vladimir Dobronravov, who presented the results at the convention, said in a press release. “Patients on low-dose voclosporin are also maintaining remission for a longer duration—nearly twice that of the control group, on average.
“The quicker we can bring patients into remission and keep them there, the more likely we are to delay or even prevent the deleterious effects of prolonged inflammation which can lead to irreversible kidney damage,” he concluded.