New Year May Bring New Lupus Treatments

"It's an exciting time in lupus," Dr. Furie says. "The foray into lupus and lupus nephritis trials started in the early 1990s. The results of our efforts was just one drug and that was belimumab approved by the FDA about 10 years ago. But, it's not for lack of trying. It's just that lupus is incredibly challenging for a lot of different reasons. We're finally starting to see the light at the end of the tunnel in systemic lupus and also lupus nephritis."

Here, Dr. Furie addresses the results of the phase three BLISS lupus nephritis (BLISS-LP) clinical trial. The results of the trial, which began in the late 1990s, showed that after 104 weeks of treatment with belimumab for lupus nephritis, 43 percent of patients in the treatment arm had a primary efficacy renal response as compared to 32 percent of patients in the placebo group. And, 30 percent of treated patients had a complete response as compared to 20 percent in the placebo group.

In previous studies of belimumab, which was approved in March 2011 as a treatment for lupus, Dr. Furie and his team tracked the impact of belimumab on renal disease. The evidence showed improvements in low grade renal disease which was supported by translational evidence eventually leading to the launch of BLISS-LN for lupus patients with biopsy-proven lupus nephritis.

This was a two-year international study in which the primary endpoint being a reduction in proteinuria. By the close of the study, there was an 11 point difference between drug performance and placebo. The secondary endpoint was complete renal response, which ultimately showed an effect size 10 percentage points. The hazard ratio for a complete renal endpoint was a 50 percent reduction in time to renal response.

"This was a history making event because it's the first trial in lupus nephritis to be successful," Dr. Furie said.

So, what's next for this study? It depends on the U.S. Food and Drug Administration which is currently considering extending the approval of belimumab to include lupus nephritis.

In this interview, Dr Furie also addresses B-cell depleters like rituximab, obinutuzumab, voclosporin and anifrolumab.

"What's interesting about lupus drug development is what I call the eclectic approach. This disease has been attacked from many different angles. There are many different pathways involved and now, several possible treatments are rising to the top. Time will tell," Dr. Furie said.

______________

REFERENCE

Click here for a comprehensive look at Dr. Furie's lupus and lupus nephritis clinical trials presented at the American College of Rheumatology 2020 annual meeting.