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FDA approves Benlysta for lupus nephritis!

posted in All on December 17, 2020 by

Donald Thomas

1st drug ever FDA-approved to treat lupus nephritis

​Historic mile-stone!

December 16, 2020: The FDA approved on Wednesday DEC 16, 2020…  Benlysta for lupus nephritis as the first drug ever FDA-approved to treat lupus nephritis (inflammation of the kidneys).
What should lupus patients know about lupus nephritis?

It is common
Lupus nephritis (LN) occurs in approximately 40% – 45% of people who have systemic lupus erythematosus (SLE). It occurs in some ethnicities more than others. For example, while 30% of Caucasian women with SLE will have LN, close to 80% of Caribbean women of African ancestry with SLE will develop LN.  

It can occur at any time 
When we look at people with LN, 1 out of 3 have LN when first diagnosed with SLE. It most commonly develops within the 1st 5 years. However, it can occur at any time, including after having SLE for many years.

It is why rheumatologists ask you for a urine sample every 3 months
It is diagnosed most commonly by finding an increased amount of protein in the urine. We want to catch it at the earliest stages possible when it is easiest to treat. Identifying it quickly increases the chances for remission.

The most common symptoms of lupus nephritis = you feel perfectly normal
Yes, that is correct. Early on with LN, there are no symptoms what-so-ever. By the time you feel any, you already have some significant kidney damage going on. Symptoms of LN once it gets to that more advanced stage include fatigue, swelling of the ankles that gets worse later on in the day (edema), weight gain (fluid retention), urinating more often at night time when in bed, foamy urine (from the increased protein in the urine).

We want to catch it when you feel completely normal. That is why it is so important to see your rheumatologist regularly when you feel great and give us that cup of urine.

Remission can and does happen! Here are the tricks to achieve remission:
– Help your rheumatologist catch it quickly by giving us a urine sample every 3 months.
– Get a kidney biopsy as quick as possible, and begin treatment as soon as possible if the urine sample is abnormal.
– Work hard on maintaining normal body weight.
– Do not smoke cigarettes. (Follow everything else in the Lupus Secrets)
– Take hydroxychloroquine (Plaquenil) religiously. It makes you 3-times more likely to go into remission.
– Take other prescribed medicines religiously (such as mycophenolate and azathioprine)
– If not on an ACE inhibitor or ARB blood pressure medicine, ask your doctor if you should, especially if you have increased protein in your urine.
– Ask your doctor to help you get your BP perfect. Have the top number (systolic) around 110 mmHg; have the bottom number less than 80 mmHg
– Keep your cholesterol perfect (take a statin if it is high)
– Exercise regularly
– Consider eating an anti-inflammatory diet (it has not been proven to put nephritis into remission because it has not been studied. However, there is good data that it can help decrease lupus inflammation in non-renal lupus.)
– Follow-up with your rheumatologist or nephrologist (kidney doctor) regularly. Your goal is to get your urine protein to creatinine ratio below 0.7 g/g (or < 700 mg:mg).

How effective is Benlysta for lupus nephritis?

In the phase III clinical trials, Benlysta IV (intravenous form) was added to the medicines we normally use to treat lupus nephritis (called standard of care, SOC).  Some patients in the study got Benlysta + mycophenolate +/- hydroxychloroquine + steroids, some got Benlysta + cyclophosphamide + steroids +/- hydroxychloroquine, while others got Placebo plus mycophenolate or cyclophosphamide ( plus steroids +/- HCQ).

Results were remarkable. The most important of which is the “complete renal response” meaning marked reduction of protein in the urine close to normal (<0.5 g/g) by week 100 and no worsening of kidney function.

Complete renal response rates at week 100 (bottom left graph):

Placebo + standard of care = 20% complete response
Benlysta + standard of care = 30% complete response

Note that this is a 50% higher amount of complete responses compared to standard of care (30% is 50% greater than 20% mathematically).

That is remarkable. (However, a caveat… we still need better treatments for that other 70% who did not go into complete remission! … read my comments at the bottom of this article for a possibility)

Graphs above come from the BLISS-LN trial published in the NEJM referenced below

How safe was Benlysta?

Benlysta continues to be one of our safest options for treating systemic lupus! There was not any statistically significant differences among side effects between the Benlysta group and the placebo group.

The most common side effects seen in the research studies were infections. However, it is important to remember that all patients were also treated with high dose steroids plus either mycophenolate or cyclophosphamide, which are strong immunosuppressant drugs. Interestingly, 0.7% of the patients who got Benlysta had infections while 1% of those on placebo did. (in other words, the other drugs, such as steroids, played the largest role in this).

Allergic reactions were seen as with any medication, but not common. For example, 0.9% of patients who received the placebo infusion had an infusion reaction, while 1.6% of those who got Benlysta did.

How is Benlysta dosed for lupus nephritis?

The IV form is the same as for other lupus problems (10mg/kg given 3 times in the first month; then 1 infusion monthly after that)

Interestingly, the self injectable subcutaneous form is different than for other types of lupus. It is recommended to do 2 injections weekly of 200 mg each (total of 400 mg) for the 1st four weeks. After that, it is just one injection weekly.

My prediction for the near future for lupus nephritis treatments

Voclosporin will probably be the next FDA-approved drug to treat lupus nephritis, and it will probably happen soon. It is a pill taken once a day.

How well did it do?
In the phase III clinical trial:
41% of the voclosporin + standard of care group had a complete response!
23% of the placebo + SOC group had a complete response

That is pretty close to twice as many patients going into remission compared to standard of care.

And voclosporin was safe! It is in the same group of drugs called calcineurin inhibitors (cyclosporine and tacrolimus) and it is safer than those two.

And what would happen if we were to use both voclosporin and Benlysta both together? They work through different mechanisms. We could potentially see even great remission rates.

As you can probably tell. I am pretty excited about the future of better therapies for lupus! They are not possibilities… they are actually happening right now.


Don Thomas, MD, author of The Lupus Encyclopedia and The Lupus Secrets


Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180. PMID: 32937045.

1 Comment

  1. Benlysta is too large of a molecule to be taken by pill form. The stomach and intestines would just destroy it and absorb just parts of it. Therefore, it is a self-injectable and an IV treatment for lupus instead. If you are reading this before your Benlysta first infusion

    or injection, that is wonderful! But, make sure to learn more by reading other Benlysta reviews as well. ​Yet, during infections, the immune system can still make lots of BLyS so that the important, needed B-cells can fight off the infection.

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