Voclosporin therapy reached study endpoints at 48 weeks for patients with lupus nephritis

MADRID — Patients with lupus nephritis who were treated with a voclosporin-based combination therapy met all primary and secondary endpoints, including durable complete remission, according to findings presented at the EULAR Annual Congress.

“Voclosporin [Aurinia Pharmaceuticals] combined with [mycophenolate mofetil] MMF and steroids leads to increased rates and duration of complete response in patients with active lupus nephritis,” Vladimir Dobronravov, MD, of Pavlov First St. Petersburg State Medical University in St. Petersburg, Russian Federation, said. “AURA-LV is the first global study to meet the primary endpoint and all secondary endpoints in patients with active lupus nephritis. A multi-targeted approach allowed for clinical response using a steroid-reduced protocol with an appropriate safety profile.”

In the study, voclosporin was administered with mycophenolate mofetil and steroids. The study drug was assigned at either a low dose of 23.7 mg twice daily to 89 patients or a high dose of 39.5 mg daily to 88 patients. The control group included 88 patients. The primary endpoint was the proportion of patients in complete remission at 24 weeks and at 48 weeks. Partial remission, time to remission and durability of remission served as secondary outcome measures.

Results from 24 weeks showed 33% of patients in the low-dose arm, 28% of those in the high-dose arm and 19% of controls reached a complete response. At 48 weeks, the rates were 49.4% for the low dose (odds ratio [OR] = 3.21 compared with controls), 39.8% (OR = 2.10 compared with controls) for the high dose and 23.9% for controls.

“The study did reach the primary outcome,” Dobronravov said.

The duration of complete response was 123 days for the low dose and 111 days for the high dose, which Dobronravov noted was twice the duration reported for controls.

He also noted a “significant reduction” in the SLE disease activity index score.

Safety data showed 92% of patients experienced at least one adverse event. The most commonly reported events were infections and gastrointestinal disorders. Serious adverse events occurred in 28% of patients in the low-dose arm, in 25% of those in the high-dose arm and in 19% of controls.

“Serious adverse event rates were comparable to other global lupus nephritis studies,” Dobronravov said.

There were 13 deaths. Dobronravov noted 11 of those incidents occurred at sites with compromised access to standard of care.

“Patients who died had a statistically different clinical baseline picture, with more severe lupus nephritis,” he added. — by Rob Volansky

References:

Dobronravov V, et al. Abstract #LB0002. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.

Disclosure: Dobronravov reports receiving grant or research support from Aurinia Pharmaceuticals.