Benlysta Proving Helpful for Lupus Nephritis

Lupus is an autoimmune disease that can affect many parts of your body. Lupus can affect your:1

Your kidneys’ job is to maintain the right amount and types of fluids, remove waste, and regulate hormones that control blood pressure and blood volume.1

A new study shows that a medicine called Benlysta® (belimumab) can improve kidney function in adults with lupus nephritis. The U.S. Food and Drug Administration (FDA) approved Benlysta to treat lupus in 2011. At the time, it was the first drug approved for lupus in 50 years. Now, a new study shows that Benlysta can help people with lupus nephritis.2

Lupus nephritis occurs when lupus causes inflammation in the kidneys. This makes your kidneys unable to do their job of removing waste and controlling fluids. The inflammation happens in the part of your kidneys called the nephrons. If lupus nephritis is not treated, complications like scarring, permanent kidney damage, and end-stage renal disease (ESRD) can occur. Dialysis or a transplant may be necessary.1

What were the findings in the study of Benlysta?

The international study was called BLISS-LN, and it was published in the New England Journal of Medicine (NEJM). The Phase 3 trial showed that Benlysta significantly improved kidney function in people with lupus nephritis.2

The study looked at 448 people with lupus. The people participating in the study took Benlysta plus a usual treatment for lupus: mycophenolate, or cyclophosphamide, and azathioprine. Benlysta was given by IV (intravenous, or into the vein). Half of the people in the study took Benlysta, and the other half took a placebo (inactive medicine).2,3

The BLISS-LN study was a randomized, double-blind, placebo-controlled study. The study took place in 21 countries at 107 sites and lasted for 104 weeks (2 years).3

In the people who took Benlysta in addition to their regular medicine, 43 percent had significantly improved kidney function. Also, 30 percent of people in this treatment group showed a complete renal response. This is a lab measurement that tells how much protein is in the urine and blood.2

In the people who only took their regular medicine (placebo group), only 32 percent had significantly improved kidney function. In this group, 20 percent showed complete renal response.2

People who took Benlysta also had a lower risk of a kidney-related event or death. The study showed that the safety of Benlysta was consistent with previous trials.3

The findings of this study could lead to Benlysta becoming the first FDA-approved drug for lupus nephritis.4

Why is this approval important for people with lupus nephritis?

The approval of Benlysta could make a major impact in the treatment of lupus nephritis.1,2,4

  • About 60 percent of adults with lupus and up to 66 percent of children with lupus will develop lupus nephritis.
  • Lupus nephritis is the most common severe complication of lupus.
  • Even with treatment, 30 percent of people with lupus nephritis will have end-stage renal disease and need dialysis or a transplant.
  • Significant damage may happen before you are even diagnosed with lupus nephritis. It can cause uncomfortable symptoms like swelling in the arms, legs, and eyes; blood in the urine; high blood pressure; and frequent urination.

For more information, read the full prescribing information of Benlysta.

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