Benlysta for lupus nephritis: Studies show it is effective

Hot off the press SEP 2020! The future is very bright for lupus treatments!

Anatomical drawing of a kidney with artery, vein, and ureter

 

 

 

 

The future is brighter for lupus patients! Benlysta for lupus nephritis

We have 3 drugs that are vying for FDA approval soon: Benlysta for lupus nephritis, voclosporin for lupus nephritis, and anifrolumab for systemic lupus erythematosus (SLE). All three were successful in the final research studies (called phase 3 clinical trials). In medical-speak, we say that “they met their primary endpoints.”

My (Don Thomas, MD) prediction:
Though meeting the primary endpoints in phase III clinical trials never guarantees FDA-approval (many do not), these did so well, I predict they will be the next 3 FDA-approved therapies! They all did so well, along with having excellent safety profiles (low side effects for the amount of benefits they provided).

SHARE this with all lupus patients. Everyone needs some optimism.

Why is this so joyous? In March 2011, Benlysta was the very first FDA-approved drug for lupus since President Eisenhower was president (it took over 50 years!). That is a travesty. However, the approval of Benlysta showed pharmaceutical companies that it was worth their time, effort, and money to actively research lupus in more depth and that drugs could be proven to be helpful in treating SLE. And now… we have possibly 2 new drugs just around the corner (voclosporin and anifrolumab)? Yes, it is time to rejoice, hope, and pray that the FDA finds the research results to be as good as they appear.

This post, though, is all about Benlysta. Just this week, the New England Journal of Medicine published the positive results of their research study called BLISS-LN (Link to the study is below). This stands for “BeLImumab in Subjects with SLE with Lupus Nephritis study.” It showed that Benlysta is effective for lupus nephritis.

​Let’s 1st briefly discuss lupus nephritis …    

 

Gold balloons in the shape of 50 in sunlight

 

 

 

When lupus attacks a person’s kidneys it is called lupus nephritis (nephr– refers to kidneys, –itis means inflammation). Depending on the study, overall, approximately 50% of SLE patients will get this major problem. In some populations it is much more common (such as in over 70% of Caribbean-African people with SLE), and as low as 30% in Caucasians with SLE. When caught early and treated quickly, most patients go into low disease activity or remission. If not, it can cause kidney failure, the need for dialysis, and the need for kidney transplantation. Along this very hard road, lots of deaths occur.

 

This is why rheumatologists ask to see their patients every 3 months. We want a urine sample to evaluate and make sure our patient isn’t getting lupus nephritis. When I see it as a possibility, I pounce on it and treat it aggressively. Using this approach, my only patients who have gone into kidney failure and dialysis, and then kidney transplantation were my patients who were poorly adherent to their therapy.  By the way, don’t let that happen to you! 

Read and abide by my Lupus Secrets. If you follow them, you’ll successfully fight your lupus. 

A drawing of a doctor in white labcoat with stethoscope looking at image of kidneys on laptop

 

 

 

Now for the study, in brief.

They had 224 patients in the placebo group and 224 patients on Benlysta. However, it wasn’t really placebo. The “placebo” group was getting standard of care (steroids plus either cyclophosphamide or CellCept, mycophenolate). Those who received Benlysta had their Benlysta in addition to the “standard of care.”

It had some impressive results after 104 weeks:
30% of the Benlysta group had a complete response to therapy while 20% of the placebo group did. That is 50% greater in the Benlysta group compared to standard of care plus placebo group. This is impressive. The “placebo group” is how we currently treat lupus nephritis patients! Imagine getting a 50% higher response rate by adding another medicine.

By the way, you may think, well an additional drug! That could mean more side effects. Guess what? … Serious adverse events occurred in 30% of those on standard of care treatment plus placebo, while 26% of those on Benlysta plus standard of care had serious side effects. This is actually less in the Benlysta group. However, that does not mean that Benlysta causes less side effects. This is actually not statistically significant. 

Also, don’t think this is “horrible” that 30% of patients had “serious adverse events.” Guess what would have happened without these treatments? … virtually 100% serious adverse events would have occurred due to the lupus nephritis leading to kidney failure, dialysis, kidney transplantations and deaths. (the benefits of the medicines greatly outweigh their potential side effects compared to this).

By the way, there were other impressive positive results in the study, but I wanted to hone in on the “complete renal response” result above.

Remarkably, there were only 3 deaths (2 on placebo, 1 on Benlysta), only one patient went into complete kidney failure (a placebo patient). Impressive when you realize how horrible the alternative without treatment would have been.

I’ve been using Benlysta since 2011, and I have many SLE patients who are in low disease activity and remission after failing other treatments. This includes quite a few lupus nephritis patients. In my experience, it is one of the safest medicines we have for SLE. Plaquenil is probably the only safer drug.

 

Stacks of 100 dollar bills sitting on a table

 

 

 

The primary downside of Benlysta:  EXPENSIVE! 

It comes in two forms of dosing … a self injectable every other week form, or a monthly IV (intravenous form). According to UpToDate.com, the self-injectable form costs close to US$ 30,000 a year. The IV form is more expensive (nurses, IV equipment, etc.)

So some big, important questions are:
Which patients will benefit the most?
Can we figure out which patients are at highest risk for not responding completely to standard of care therapy (CellCept and cyclophosphamide)?

If we could figure this out, then those patients should be the ones who get it.

It will be interesting to see what happens if it gets FDA-approved for lupus nephritis. I cannot imagine it not getting FDA approval, by the way. The study was that impressive.

Bottom Line?: Lots of exciting stuff happening in lupus!

Please COMMENT in “LEAVE A REPLY” below.
​Are you on Benlysta? How are you doing? What is your experience like? Do you have lupus nephritis? How have you done?

I love giving good news!
– Don Thomas, MD

 

P.S. Remember to download my Lupus Secrets to learn more!

 

Reference:

Furie R, et al. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. NEJM SEP 2020;383:1117-1128
DOI: 10.1056/NEJMoa2001180

 

Disclosure: I am on the Speaker’s Bureau for GSK, maker of Benlysta. This is the only pharmaceutical Speaker’s Bureau I am on. I truly believe in Benlysta as being a great therapy for SLE patients. It is not for everyone, but many do great on it. 

Don Thomas, MD

I specialize in taking care of patients with systemic lupus. I enjoy sharing helpful, practical information for them to use and be better able to live with and successfully fight against their disease. Make sure to read and follow my Lupus Secrets

9 thoughts on “Benlysta for lupus nephritis: Studies show it is effective

  • September 17, 2020 at 7:34 pm
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    Would a lupus patient with class 3 nephritis who has been stable on mycophenolate, hydroxychlorquine, and losartan but still has a PCR of .5 – .8 benefit by adding Benlysta or voclosporin?
    Thank you, Dr. Thomas!

    Reply
    • September 17, 2020 at 9:25 pm
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      Dear Ann: Studies show that if the random urine protein to creatinine ratio (PCR for anyone reading your question) is less than 700, then the long term prognosis is low as far as proceeding towards end stage renal disease. My only problem with this is that these studies did not follow people over many decades. If I were 30 years old and in your shoes, I’d be thinking, “I’d love to make it to my 90s as long as I’m healthy. So does this really apply to me? What if I were still having active inflammation? Couldn’t continued damage occur, though maybe at a very slow rate? Can’t we slow it down?” … If I had a patient like this, I’d offer them the option of doing a kidney biopsy and base the decision off of that. If significant inflammation is present, then proceed with therapy as you mention (such as adding Benlysta). Great question. These are the sorts of things we deal with all the time. The research studies don’t really answer them well for us. Thanks for reading my blog… Don Thomas, MD

      Reply
      • September 17, 2020 at 9:50 pm
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        Thank you so much for your thoughtful reply. I love your book. I am a physician myself (OB) and believe it is the absolute best resource for lupus patients. This young girl is 17, diagnosed 2.5 years ago, the activity index was 4/24 and the chronicity index was 4/12. I suspect this is exactly what her nephrologist will recommend.

        Reply
  • September 21, 2020 at 2:03 pm
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    Hello! Great seeing you on the LFA Call today. Here is my poem and I have another one that I performed at the Lupus Gala last year:
    You think you own me
    Squeezed my life in your palms
    Taken over my body
    You think you are me
    Lupus
    You think because
    You’ve hijacked this vessel that you’re captain
    You think you can get away with mutiny
    But see
    I’m still the same me
    The same beautiful butterfly floating on the breeze
    I ain’t scared to wrestle the wind
    To battle Raynauds thorns
    Not afraid to diss this disease
    To find peace
    Be at ease with this disease
    I miss my old life but I’m fashioning a new one with this disease
    In no way am I saying this is easy
    The way my cells fight themselves
    That my chest being in a cage of pleurisy
    That my scalp cries strands of my hair
    That the pain in my knees which interfere with my prayers
    Make it hard to sometimes find the joy in life
    Makes the sun less bright
    But I know no matter what
    There’s nothing that’ll take away my fight
    When it seems to make my day feel like night
    I’ll still reach for a star
    When it seems my world spins left
    I’ve resolved to force it to revolve right
    And even if my limbs refuse to move
    My spirit will still dance
    Every day I’m going to
    Choose to enhance this universe with my presence
    In any way I can
    Lupus is not me
    But it’s the spark that created a flame
    My disease is not me
    But it’s the source of my vanity
    Lupus you can’t damage me
    Because my body isn’t all I possess
    I still have a purpose
    A reason to smile
    I’m still living my life with no regrets.
    Copyright Shanelle Gabriel

    Reply
    • September 23, 2020 at 6:42 pm
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      Shanelle: Love your poem, and it was wonderful to see you on the Lupus Foundation’s online get together as well. I shared your post; I hope you don’t mind my “stealing” your pic from your website:
      https:/www.lupusencyclopedia.com/blog/a-poem-by-lupus-warrior-and-advocate

      Reply
  • October 1, 2020 at 12:26 pm
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    Thank share Great info!

    Reply
  • October 7, 2020 at 12:15 pm
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    Hi
    Happy to hear of the new info for Benlysta. I actually just started my first infusion on Friday.
    I tolerated it very well, but late Saturday into Monday got increasingly significant fatigue and arthalgias. In general is this something that can be due to the Benlysta and is it likely to become less of an issue with time or was I just unlucky enough to start into a flare right away?
    Secondly, any upcoming data to show that those on Benlysta without current renal issues have any protection from progressing to renal involvement by being treated with Benlysta?
    Thanks! Love to read your blog – very informative!

    Reply
    • October 7, 2020 at 2:06 pm
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      Chrystal: Any time we use a medicine that calms down the immune system, occasionally a mild flare can occur. Benlysta is very slow to work. If it ends up working, it can take 6-12 months for the full effects. Thus far, the 7-year long extension studies have shown significantly less organ damage in patients taking Benlysta plus their usual lupus meds compared to lupus patients who take standard of care medications without Benlysta. This is very exciting. If it works, nephritis should not occur. I’ve used it in many SLE patients since 2011 and have never had a patient develop nephritis while on it. I hope you have a good result using it as one of your lupus medications.
      Thanks so much for reading my blog and commenting

      Reply
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