Belimumab is the Second Drug to be Developed for Lupus in Over Fifty Years


Dr. Richard Furie at New York’s Feinstein Institutes recently interviewed with MedPage Today. Dr. Furie discussed the prognosis for lupus nephritis and belimumab (Benlysta), a recently-tested drug that appears to improve patients’ outcomes. An estimated twenty to sixty percent of lupus patients will develop lupus nephritis. These statistics have not changed for the past thirty years. In fact, only one therapy has been approved in the past fifty years.

In an autoimmune disease such as lupus, the immune system in the body will attack its own organs and cells. Lupus nephritis is caused by systemic lupus erythematosus (“lupus” or SLE). It is a chronic, inflammatory, connective tissue disease affecting joints and various organs such as lungs, heart, or nervous system.

Dr. Furie cautions that this condition may worsen and lead to dialysis or a kidney transplant.

About Belimumab (Benlysta)

Belimumab, a monoclonal antibody, inhibits the B-cell survival factor known as the B-cell activating factor. These antibodies are produced artificially through genetic engineering.

Benlysta was originally approved to treat SLE in 2011 based on two clinical trials, BLISS-52 and BLISS-76. But lupus nephritis patients were not included in the studies. Therefore, a phase III trial assessing 448 lupus nephritis patients was conducted during 2012 and 2017. The trials, the largest ever conducted for lupus nephritis, were held at over one hundred sites across twenty-one countries.

The majority of participants were Asian, fourteen percent were Black, and about ninety percent were women. Most patients were diagnosed as having class III or class IV nephritis. The median age was thirty-three with three years since their SLE diagnosis.

The study was published in the New England Journal of Medicine and sponsored by GlaxoSmithKline. Adult patients were assigned intravenous belimumab (Benlysta) or matching placebo in addition to standard therapy.

Trial Results

Dr. Furie reported that patients receiving Benlysta and standard therapy (Cellcept) showed a substantially higher renal response at the two-year mark than the patients receiving standard therapy plus a placebo.

Mycophenolate mofetil (Cellcept) is an immunosuppressant drug that weakens the immune system. It is used to treat autoimmune diseases.

Dr. Furie reported that at week 104, patients treated with belimumab had a forty-three percent renal response compared to thirty-two percent in the placebo group.

The belimumab arm showed a fifty percent lower mortality risk or risk of progressing to end-stage kidney disease.

The investigators point out that only patients who were treated with mycophenolate mofetil (Cellcept) had a renal response as opposed to patients receiving cyclophosphamide-azathioprine. The investigators considered the possibility that patients receiving the latter may have had a more resistant type of nephritis.

Mortality in Trial Arms

The investigators reported that eleven patients died during the trial. Six of the deaths, three in each arm, were infection-related. The deaths were not related to lupus nephritis.

Six of the deceased patients had been in the belimumab group. Thirteen percent of patients in the two groups had to withdraw from the trial due to adverse events.

The researchers noted that there were several limitations to the study. Namely, the low number of patients from the Black community and also data on patient-reported results.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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