Benlysta First Agent Approved for Lupus Nephritis Save

After the successful completion of the BLISS-LN trial and previewing the results at EULAR 2020 and ACR Convergence, GlaxoSmithKline announced yesterday that the FDA has approved belimumab (Benlysta) for use in adults with active lupus nephritis (LN) receiving background/standard therapy.

Belimumab was first approved in March 2011 for use in systemic lupus erythematosus (SLE) and received its' second indication for pediatric (children over age 5 yrs) SLE in April 2019. The drug is also approved for use in children and adults as and intravenous (10 mg/kg) and subcutaneous (200 mg weekly) dose.  

Several agents are underdevelopment with lupus nephritis as an indication, including voclosporin (from Aurinia) and obintuzumab (from Genentech), but belimumab is the first to be approved specifically for lupus nephritis.

FDA approval is based on the results of the BLISS-LN phase 3 study conducted in 448 active adults LN patients. The study met its primary renal endpoint with statistically significant more patients achieving Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) with belimumab plus standard therapy compared compared with placebo plus standard therapy (43% vs 32%, p=0.0311).  Patients on belimumab had a 49% lower risk a renal-related event. Subanalyses of this study presented at ACR 2020 showed favorable responses with class III and class IV LN, but not with class V GN> 

In this trial, background standard therapy included either mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids.

Belimumab is not recommended in patients with severe active central nervous SLE.