Phase 2 CALIBRATE Study Indicates Benlysta as Additional Therapy for Lupus Nephritis is Safe
Results from the Phase 2 CALIBRATE study found that a maintenance treatment regimen that includes Benlysta (belimumab) after treatment with Rituxan (rituximab) and cyclophosphamide (CYC) immunosuppressive therapy is safe for people with lupus nephritis (LN). Additionally, the combination therapy may also stop B cells from developing and evolving. In people with lupus, B cells can produce autoantibodies which cause inflammation and tissue damage.
The “Combination of Antibodies in Lupus Nephritis: Belimumab and Rituximab Assessment of Tolerance and Efficacy” (CALIBRATE) study assessed 43 people with recurrent or refractory LN (LN that did not respond to first-line immunosuppressive drugs or quickly relapsed after remission) who previously received standard treatment. At week 48, complete or partial renal response occurred in 52% of those receiving Benlysta vs. 41% who did not. At week 60, B cell depletion occurred in both groups and remained lower in those who continued to receive Benlysta with no clinically significant differences between the two groups.
Sam Lim, MD, MPH, study author and member of the Lupus Foundation of America Medical-Scientific Advisory Council, notes, “This study is important because we clearly need more treatments for those with lupus nephritis. Though cyclophosphamide and mycophenolate mofetil have greatly improved outcomes and people’s lives, there are still significant numbers of people who do not completely respond to current therapies or cannot take them for various reasons.”
He adds, “Instead of simply looking at another type of medication, this study is looking at how a biologic therapy (Rituximab) in combination with a current medication (cyclophosphamide) might be given safely and effectively. Although the safety was good, the outcomes did not improve with the combination therapy. However, this paves the way for other novel combination treatments to be looked at more closely, potentially providing new and safe options for many who desperately need it.”
“CALIBRATE studied a novel approach of giving sequential therapy with B cell depletion (Rituximab) followed by an anti-BAFF agent (belimumab) and showed that giving these two biologic agents was safe,” said Cynthia Aranow, MD, another study author. “It also gave us important insights into its mechanism of action.” Further research is needed for combination drug therapies; continue to follow the Lupus Foundation of America for updates.