Patient Information in easy-to-understand language
Lupus inflammation of the kidneys (lupus nephritis, LN) video below:
- LN affects 40% of SLE patients
- People with LN do not feel badly until it becomes severe
- This is why your rheumatologist asks you to do a urine sample every 3 months (hopefully)
- This is why you should do a frequent urine sample. The faster it is diagnosed, the faster it is treated, the higher the chances for remission
- These are unprecedented times for LN. We have the 1st two ever FDA-approved drugs for LN
Lupkynis (voclosporin, 1/22/21) and Benlysta (belimumab, 12/17/20)
- Both of these drugs greatly increase the chances for remission, allowing less usage of steroids
- WATCH THE VIDEO TO LEARN MORE ABOUT LUPUS NEPHRITIS!
- Brought to you by Aurinia, Lupus Chick, The Lupus Foundation of New England, and Don Thomas, MD
Lupus Question of The Day: Is Benlysta for mild nephritis?
Question of the Day:
"I have lupus nephritis and just heard that Benlysta has been approved to treat it. I have stage 3 disease. Is this medication more for people with mild nephritis?"
Dr. T's Answer:
"It all depends upon what your definition is of "mild nephritis." I would consider ISN/RPS classes 1 (minimal mesangial) and 2 (mesangial proliferative) as mild. They do not need treatment at all (except for Plaquenil/hydroxychloroquine plus often an ARB or ACEi medicine to lower protein in the urine). Podocytopathy could also be considered a "mild" type of lupus nephritis. Usually goes into remission quickly with Plaquenil plus steroids, with a rapid steroid taper. Therefore, for my definitions of "mild" lupus nephritis, Benlysta is not needed.
The Benlysta lupus nephritis clinical trial (called BLISS-LN) showed that when Benlysta was added on top of standard of care (Plaquenil, steroids and either mycophenolate or cyclophosphamide) there were significantly more people who improved on Benlysta plus standard of care compared to those who were treated with standard of care alone. More patients had partial or complete responses (including remissions) compared to standard of care (i.e. how we treat lupus nephritis before Benlysta). Plus... there were no significant differences in side effects, which is amazing. Also, more patients who got placebo plus standard of care died or went into complete kidney failure compared to the Benlysta group.
This is all great news. The lupus community is excited about this landmark event: Benlysta being the first FDA-approved drug for lupus nephritis ever. "
Thanks to Kelli of "More than Lupus" for producing the "Ask Dr. T" series!
Don Thomas, MD, author of "The Lupus Encyclopedia" and "The Lupus Secrets"
Watch YouTube video about lupus nephritis linked below
You will learn:
- Why lupus nephritis is important for all systemic lupus patients
- How to properly collect a urine specimen
- The symptoms of lupus nephritis
Did you know that the most common symptom of early lupus nephritis is no symptoms at all?
- The different kinds of lupus nephritis
- How it is diagnosed
- The importance of diet, exercise, mindfulness
- How it is treated
- What happens when it is not treated
- How to get the most out of virtual online doctor visits
- An online support group for people who have lupus nephritis
Video produced by Lupus Foundation of New England and Marisa Zeppieri "Lupus Chick"
Presented by Dr. Donald Thomas, MD, author of "The Lupus Encyclopedia" and "The Lupus Secrets"
Sponsored by Aurinia Pharmaceuticals
Donald Thomas, MD author of "The Lupus Encyclopedia" and "The Lupus Secrets"
Hot off the press SEP 2020! The future is very bright for lupus treatments!
The future has never been brighter for lupus patients!
We have 3 drugs that are vying for FDA approval soon: Benlysta (belimumab) 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 ...
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.
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.
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
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
Note that Dr. Thomas' posts are for informational purposes only, and are not meant to be specific medical advice for individuals. Always seek the advice of your healthcare provider with any questions regarding your own medical situation.
DONALD THOMAS, MD