Aurinia Pharmaceuticals Inc (AUPH) オプション

New guidelines coming out

Healio: What were the strong recommendations in the new document?

Sammaritano: Our strong recommendations rely on a combination of evidence, clinical expertise, and patient panel input. They are important in preventing serious adverse outcomes and are applicable to almost all people with lupus nephritis.

Strong recommendations include screening at least every 6 to 12 months for proteinuria in people with SLE without known kidney disease, or when experiencing extra-renal flares, as well as quantifying proteinuria at least every 3 months in those with lupus nephritis who have not achieved complete renal response, and every 3 to 6 months in those with sustained complete renal response.

For those with active lupus nephritis who are not already on hydroxychloroquine, we strongly recommend initiation and continuation of hydroxychloroquine therapy to manage and prevent lupus clinical manifestations, unless contraindicated.

In people with lupus nephritis who have progressive refractory disease and are approaching kidney failure, we strongly recommend kidney transplantation over dialysis.

Finally, in those who are on current dialysis or who have had a kidney transplant, we strongly recommend regular follow up with a rheumatologist in addition to the nephrologist.

Healio: What do these recommendations mean for patient care? What impact do you expect them to have?

Sammaritano: Lupus nephritis manifests in close to half of people with SLE, and 10% to 22% of impacted patients develop end-stage kidney disease. We hope these new recommendations, which incorporate the most recently published treatment trials, enable clinicians and patients to have the best discussion possible regarding therapy, one that is based on the most recent data and clinical expertise.

We recognize that there are many variables involved in treatment decisions, including clinical presentation and patient preferences, and that treatment may be limited by access to specialists, procedures and medications.

As a result, this guideline does not preclude using available traditional therapies. We hope, however, that it expands the possibilities for improved outcomes for more people who are living with lupus nephritis.

Kidney function declines in everyone over time, but in people with lupus nephritis it occurs at an accelerated rate for as long as the inflammatory process is present. In addition, even after inflammation is controlled, a later recurrence of active lupus nephritis imposes further loss in kidney function.

Even with the preferred triple therapy, the complete response rates reported in studies were still only in the 40% to 50% range.

As a result, an important overall message is to diagnose and treat lupus nephritis as promptly and effectively as possible to minimize risk of long-term damage and preserve kidney function.

Healio: Were there topics you hoped to cover, or recommendations you were hoping to make, but were unable to for any reason? What are the shortcomings of this document?

Sammaritano: We compiled a research agenda based on those topics that are promising and/or relevant, but for which we do not have enough data or experience to formulate recommendations at this time. They include optimal timing of repeat kidney biopsy, most effective treatment for less common lupus nephritis subsets — for example, lupus podocytopathy and others — the potential use of non-immunosuppressive medications for other chronic kidney disease — such as sodium-glucose cotransporter-2 (SGLT2) inhibitors — and the use of serum and urinary biomarkers to better reflect disease activity.

Healio: Looking ahead, what ground do you expect to cover for the next iteration of lupus nephritis recommendations? Pending FDA approvals, new mechanisms of action, or other advances in the field?

Sammaritano: We are excited about the promise of new agents for the treatment of lupus nephritis that are in various phases of development. For example, data suggesting benefits from obinutuzumab (Gazyva, Genentech) treatment have been recently reported, although not yet formally published, and so were not considered for this current guideline.

We plan to revise this lupus nephritis guideline regularly, including when important new data are published. Assuming the evidence, voting panel discussion, and patient panel preference all support inclusion of newly approved agents, these would potentially be incorporated as recommended therapy in a revised, updated guideline.

References:
Furie R, et al. NEJM. 2020;doi:10.1056/NEJMoa2001180.

Rovin BH, et al. Lancet. 2021;doi:10.1016/S0140-6736(21)00578-X.

Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Disclosures: Sammaritano reports no relevant financial disclosures.
Read more about
lupus nephritis
lupus
chronic kidney disease
clinical guidelines
american college of rheumatology
Add topic to email alerts
Facebook
Twitter
LinkedIn
Email
Print
Comment

American College of Rheumatology Annual Meeting
healio rheumatology logo
ByRob Volansky
Fact checked byShenaz Bagha
December 11, 2024
2 min read
SAVE
ACR recommends triple therapy for lupus nephritis in new 2024 guidelines

WASHINGTON — Early triple therapy may be the most effective strategy for lupus nephritis, according to the new 2024 American College of Rheumatology Guideline for the Screening, Treatment, and Management of Lupus Nephritis.

The 2024 document, which was presented in a press conference at ACR Convergence 2024, includes 41 recommendations overall.

Lisa Sammaritano, MD, speaks during ACR Convergence 2024.
“We have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients,” Lisa Sammaritano, MD, said during a press conference. Image: Rob Volansky | Healio Rheumatology
“We have very convincing evidence that starting with triple therapy yields better long-term outcomes for our patients than starting with two agents and waiting to see if they respond before escalating to triple therapy,” Lisa Sammaritano, MD, lead author of the updated guideline, professor of clinical medicine at Weill Cornell Medicine, and an attending physician in the Hospital for Special Surgery, said at the press conference.

According to Sammaritano, the ACR’s previous lupus nephritis clinical practice guidelines had called for induction therapy, with high-dose glucocorticoids plus immunosuppressant medications, such as mycophenolate mofetil or cyclophosphamide, as well as mycophenolate for maintenance therapy.

“Since then, belimumab and voclosporin have been approved by the FDA for treatment, prompting a conceptual shift from induction and maintenance therapy to one of combination, ongoing therapy targeting different parts of the immune system,” Sammaritano said in a press release announcing the update.

Among the new document’s strong recommendations, the ACR counsels rheumatologists to screen for proteinuria at least every 6 to 12 months — or in the event of extra-renal flares — in patients with systemic lupus erythematosus who do not have known kidney disease. Quantifying proteinuria at least every 3 months in patients with lupus nephritis who have not reached a complete renal response is also strongly recommended. For patients with sustained complete renal response, proteinuria screening should occur every 3 to 6 months.

Meanwhile, a key conditional recommendation for screening suggests rheumatologists perform a kidney biopsy in patients with SLE demonstrate high protein levels in their urine — defined as 0.5 g/g — and/or impaired kidney function not otherwise explained.

Regarding treatment, an immunosuppressive triple-therapy regimen is conditionally recommended in patients with active Class III & IV lupus nephritis. This regimen may include glucocorticoid plus mycophenolate plus belimumab (Benlysta, GlaxoSmithKline), mycophenolate plus calcineurin inhibitor therapy, or low dose cyclophosphamide plus belimumab.

Lower doses of glucocorticoids are recommended after initial IV pulse therapy, according to the document.

In addition to recommendations for adults and pediatric patients, the guideline also includes recommendations for withdrawing therapy, according to Sammaritano.

“We are also recommending 3 to 5 years of treatment,” she said. “We know that while clinical response may occur, often times there is still ongoing inflammation in the kidney itself. We want to make sure that is completely treated before withdrawing medication.”

Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Source: Sammaritano L. Press conference. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
Disclosures: Sammaritano reports no relevant financial disclosures.

Healio: What were the strong recommendations in the new document?

Sammaritano: Our strong recommendations rely on a combination of evidence, clinical expertise, and patient panel input. They are important in preventing serious adverse outcomes and are applicable to almost all people with lupus nephritis.

Strong recommendations include screening at least every 6 to 12 months for proteinuria in people with SLE without known kidney disease, or when experiencing extra-renal flares, as well as quantifying proteinuria at least every 3 months in those with lupus nephritis who have not achieved complete renal response, and every 3 to 6 months in those with sustained complete renal response.

For those with active lupus nephritis who are not already on hydroxychloroquine, we strongly recommend initiation and continuation of hydroxychloroquine therapy to manage and prevent lupus clinical manifestations, unless contraindicated.

In people with lupus nephritis who have progressive refractory disease and are approaching kidney failure, we strongly recommend kidney transplantation over dialysis.

Finally, in those who are on current dialysis or who have had a kidney transplant, we strongly recommend regular follow up with a rheumatologist in addition to the nephrologist.

Healio: What do these recommendations mean for patient care? What impact do you expect them to have?

Sammaritano: Lupus nephritis manifests in close to half of people with SLE, and 10% to 22% of impacted patients develop end-stage kidney disease. We hope these new recommendations, which incorporate the most recently published treatment trials, enable clinicians and patients to have the best discussion possible regarding therapy, one that is based on the most recent data and clinical expertise.

We recognize that there are many variables involved in treatment decisions, including clinical presentation and patient preferences, and that treatment may be limited by access to specialists, procedures and medications.

As a result, this guideline does not preclude using available traditional therapies. We hope, however, that it expands the possibilities for improved outcomes for more people who are living with lupus nephritis.

Kidney function declines in everyone over time, but in people with lupus nephritis it occurs at an accelerated rate for as long as the inflammatory process is present. In addition, even after inflammation is controlled, a later recurrence of active lupus nephritis imposes further loss in kidney function.

Even with the preferred triple therapy, the complete response rates reported in studies were still only in the 40% to 50% range.

As a result, an important overall message is to diagnose and treat lupus nephritis as promptly and effectively as possible to minimize risk of long-term damage and preserve kidney function.

Healio: Were there topics you hoped to cover, or recommendations you were hoping to make, but were unable to for any reason? What are the shortcomings of this document?

Sammaritano: We compiled a research agenda based on those topics that are promising and/or relevant, but for which we do not have enough data or experience to formulate recommendations at this time. They include optimal timing of repeat kidney biopsy, most effective treatment for less common lupus nephritis subsets — for example, lupus podocytopathy and others — the potential use of non-immunosuppressive medications for other chronic kidney disease — such as sodium-glucose cotransporter-2 (SGLT2) inhibitors — and the use of serum and urinary biomarkers to better reflect disease activity.

Healio: Looking ahead, what ground do you expect to cover for the next iteration of lupus nephritis recommendations? Pending FDA approvals, new mechanisms of action, or other advances in the field?

Sammaritano: We are excited about the promise of new agents for the treatment of lupus nephritis that are in various phases of development. For example, data suggesting benefits from obinutuzumab (Gazyva, Genentech) treatment have been recently reported, although not yet formally published, and so were not considered for this current guideline.

We plan to revise this lupus nephritis guideline regularly, including when important new data are published. Assuming the evidence, voting panel discussion, and patient panel preference all support inclusion of newly approved agents, these would potentially be incorporated as recommended therapy in a revised, updated guideline.

References:
Furie R, et al. NEJM. 2020;doi:10.1056/NEJMoa2001180.

Rovin BH, et al. Lancet. 2021;doi:10.1016/S0140-6736(21)00578-X.

Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Disclosures: Sammaritano reports no relevant financial disclosures.
Read more about
lupus nephritis
lupus
chronic kidney disease
clinical guidelines
american college of rheumatology
Add topic to email alerts
Facebook
Twitter
LinkedIn
Email
Print
Comment

American College of Rheumatology Annual Meeting
healio rheumatology logo
ByRob Volansky
Fact checked byShenaz Bagha
December 11, 2024
2 min read
SAVE
ACR recommends triple therapy for lupus nephritis in new 2024 guidelines

WASHINGTON — Early triple therapy may be the most effective strategy for lupus nephritis, according to the new 2024 American College of Rheumatology Guideline for the Screening, Treatment, and Management of Lupus Nephritis.

The 2024 document, which was presented in a press conference at ACR Convergence 2024, includes 41 recommendations overall.

Lisa Sammaritano, MD, speaks during ACR Convergence 2024.
“We have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients,” Lisa Sammaritano, MD, said during a press conference. Image: Rob Volansky | Healio Rheumatology
“We have very convincing evidence that starting with triple therapy yields better long-term outcomes for our patients than starting with two agents and waiting to see if they respond before escalating to triple therapy,” Lisa Sammaritano, MD, lead author of the updated guideline, professor of clinical medicine at Weill Cornell Medicine, and an attending physician in the Hospital for Special Surgery, said at the press conference.

According to Sammaritano, the ACR’s previous lupus nephritis clinical practice guidelines had called for induction therapy, with high-dose glucocorticoids plus immunosuppressant medications, such as mycophenolate mofetil or cyclophosphamide, as well as mycophenolate for maintenance therapy.

“Since then, belimumab and voclosporin have been approved by the FDA for treatment, prompting a conceptual shift from induction and maintenance therapy to one of combination, ongoing therapy targeting different parts of the immune system,” Sammaritano said in a press release announcing the update.

Among the new document’s strong recommendations, the ACR counsels rheumatologists to screen for proteinuria at least every 6 to 12 months — or in the event of extra-renal flares — in patients with systemic lupus erythematosus who do not have known kidney disease. Quantifying proteinuria at least every 3 months in patients with lupus nephritis who have not reached a complete renal response is also strongly recommended. For patients with sustained complete renal response, proteinuria screening should occur every 3 to 6 months.

Meanwhile, a key conditional recommendation for screening suggests rheumatologists perform a kidney biopsy in patients with SLE demonstrate high protein levels in their urine — defined as 0.5 g/g — and/or impaired kidney function not otherwise explained.

Regarding treatment, an immunosuppressive triple-therapy regimen is conditionally recommended in patients with active Class III & IV lupus nephritis. This regimen may include glucocorticoid plus mycophenolate plus belimumab (Benlysta, GlaxoSmithKline), mycophenolate plus calcineurin inhibitor therapy, or low dose cyclophosphamide plus belimumab.

Lower doses of glucocorticoids are recommended after initial IV pulse therapy, according to the document.

In addition to recommendations for adults and pediatric patients, the guideline also includes recommendations for withdrawing therapy, according to Sammaritano.

“We are also recommending 3 to 5 years of treatment,” she said. “We know that while clinical response may occur, often times there is still ongoing inflammation in the kidney itself. We want to make sure that is completely treated before withdrawing medication.”

Published by:
healio rheumatology logo
Sources/DisclosuresCollapse
Source: Sammaritano L. Press conference. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
Disclosures: Sammaritano reports no relevant financial disclosures.

"Jess.......do we have a bead on the date and location of the 2025 annual meeting? I am growing a wild hair to see this one in person. It would be interesting if this bunch sent the proverbial caravan."


Jess, I assume everyone will be arriving in Pintos?

"Aurinia is like the SS Minnow waiting to be rescued."


I'll help Ginger...

Chart is ominous......

looking great here
pete deserves a raise, lets vote him a 20 million a year paycheck

Uber in...

I will have to check out what you say but some there have been expecting a BO for years

...on Stocktwits.com they expect a buyout next week, would be nice...   ...was a long time to wait...

I'll help Ginger....

Jess.......do we have a bead on the date and location of the 2025 annual meeting? I am growing a wild hair to see this one in person. It would be interesting if this bunch sent the proverbial caravan.

Aurinia is like the SS Minnow waiting to be rescued.

What a disastrous last 30 days for the stock price.  Haven't seen anything that is so negative to warrant this, but definitely discouraged with the action. 

One would hope the company's overseas marketers are on top of that situation.

Have they been approved for reimbursement in some of the EU counties?

I think the company has enough flames underneath it these days to make something happen so it doesn't enter its next annual meeting without progress. Personally, I'm a bit anxious to see how initial revenues in Japan and the EU are coming along.

Same to you Moose.Hopefully, this year will be the year it will be bought. Buyer will still have more than 10+ years ownership of the patent of the only drug that treats and provides LN patients with a quality of life they need for a period much much longer than other LN patients on other medications.I hope they put that as a notation for this drug.

Wishing you and your wife and everyone else here a bountiful and healthy new year. Cheers!!!

Jess

Happy and prosperous New Year to you and the board as well.  

Think you are correct that this doesn't get packaged for less than $15.  My guess also that it doesn't go for massively more either based on the fact that the strategic review came up empty.  So $15-$20 imo.  

Merry Christmas to all and to all.....WAIT! That's clearly wrong!

Happy New Year!

Couldn't resist nibbling today as I think Tang's instincts are on target.
Doesn't this have to be worth at least $15 minimum?

Jess- Best to you and yours and thanks for your wisdom, inspiration and steady and consistently positive outlook! I see from reading your reply to my prior post that you just never give up on anyone as you clearly believe/know we all have the ability to improve (we're all moving targets and hopefully growing and learning every day).

So best wishes to everyone for the coming year and God Bless You and Yours!

Glad it's working for you. http://archive.fast-edgar.com/20241209/ARL2B22CKM228TZZ2K262ZZZMU4OK2W2Z262/
Tang now owns 8,429,500 shares after buying another 1.2 m in the above transaction .
Insider buying ... almost always a good sign

Kiwi

I don't see what all the excitement is about? a momentary run followed by a continual downturn.

Long time no hear, bro! Sad to say that Cervelo, our resident pessimist, is still here. Hopefully, the price ascent will change his mood. I doubt it but I don’t give up that easily on human being’s ability to change.

Fishy, fried broiled or blackened Alan?

The greatest thing about reaching $12.50 is that cervelo promised to leave when that happens!

And the Salvation Army benefits as well- perfectly fitting for the season!

Cheers to all

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172495222

Well, now that we have surpassed and made a new 52 week high, we can attack the 104 week high at just under $12.50.

As always seems to be the case for me, I worry that just at this starts moving north, the overall market in some sectors is so overvalued that some are
talking about some sizable profit-taking for the market as a whole. Hope it doesn't affect us here or some other stocks that I have that I consider undervalued.

Big volume yesterday, hopefully continues today.

He had disclose as he already owned over 5%...

Could, I extremely doubt Tang has PG on that long of a leash. 

Seems like you answered your own question. Tell us why you think it is fishy.

BOD members & management have rules that
they must (but sometimes do not) follow. Tang is
far too big of a fish to do anything that is illegal,
and he has access to legal council that should keep
him out of trouble. One question I have is can a BO
of Aurinia still happen after such a large insider purchase?
Maybe...For example what if PG is the only BOD member
negotiating with BP and will not disclose any details to the
BOD until he believes it is the right deal? Tang may not be
privy to any details (presuming PG is in discussions) but he
may be clued in that something is up. The fact that AUPH
is downsizing just as the company turns profitable is "interesting."

But if he wants to keep the benefits to himself, why did he disclose to the public he bought that much shares? I know it is a regulatory requirement to do so but something is fishy.

Sadly, the biotech world is corrupt and these BOD
members will always find ways to benefit from situations
even if technically it may be illegal to do so, they will find
a way. My speculation is that Tang "knows" that AUPH
will be acquired by BP at a time and a price that will enrich
himself and the other board members. Even PG made a
comment at the conclusion of the strategic review that at
anytime a BP can make an offer for AUPH, even though
the strategic review process had ended. Maybe PG set
the bar to high for an official offer to be made at that time.
As of right now, it looks as if AUPH is more attractive than
it was in the past. Tang knows how the game is played!

Yep. So by the fact that he is chairman, his purchase now means that there is no imminent BO. Whether he is ultimately planning to take it private or a BO, what this means though is that he is interested in increasing shareholder value. So, whether BO or not, I am happy with a rising stock price.

Seems as if he is setting up AUPH to be acquired...Or
maybe to attempt to take it private first. Given all of the
employee reductions it seems they may be cleaning house
for a BP BO. Hope if there is a BO it will be announced
within a year.

Tang apparently bought another 1.2 million shares between Dec 5 and 8 I think:

https://ng.investing.com/news/insider-trading-news/kevin-tang-buys-1082-million-in-aurinia-pharmaceuticals-shares-93CH-1666747

...now at 9.60😇

BR, I told Kiwi that a couple of months or so back.

I detect bitterness. You had the opportunity to get out much higher. Please don't place the underperformance with anyone else, but you..

This is in the grove now. don't let it get away

Attacking the 52 week high.  Question is whether it drives thru it or tops out at 9.50. 

Thx. but near term I'm more interested in ARDX and UNCY .
Both will benefit if the Kidney Patient Act pass's this yr .
New push in Congress
https://higherlogicdownload.s3.amazonaws.com/NRAA/8eb5e347-a0f4-4216-aac1-f22e0d697983/UploadedImages/Content/2024/RHA_Advocates_to_Protect_Access_to_Phosphate-Lowering_Therapies_11_21_24.pdf

High risk ...not investment advice etc
Kiwi

it has to be expensive
have to cover petties 10 million a year for being incompetent somehow.
go ahead and gamble here throw 1700.00 dollars at it like jes has.

Well Jess I look forward to you reminding me to buy AUPH at $6 ...if it hits $12 .
I wouldn't be surprised if Tang made an offer to take over the Co at around $10 -$12. The new ACR guidelines should definitely help drive script numbers but remember without insurance Lupkynis is around $93,000 a yr while Benlysta is around $43,000 a year .
Lupy is a very expensive drug
So insurers want Nephrologists to try Benlysta first and only cover Lupy if they fail on Benny .

I'm more interested in VERA who appear to have the best drug for IgAN
Completed enrollment of the primary endpoint cohort in the pivotal Phase 3 ORIGIN 3 trial of atacicept in IgAN; topline data expected in Q2 2025
So Q2 in 2025 top line data .
ARDX ... interesting situation with their drug Xphozah for lowering serum phosphorous in dialysis patients .
Medicare to drop coverage starting Jan 25 since they haven't applied for the TDAPA process which would now put them into the dialysis bundle and eventually limit their script numbers because of the way the bundle works .
So these patients are about to lose coverage for the only drug that works for some getting their pho levels to goal ...where all the existing meds don't.
Kidney Patient Act in Congress with 42 co sponsors now, to try and maintain coverage but running out of time .
Compromise with CMS is possible
UNCY ..one of the best new drugs for serum pho ...PDUFA data mid 2025 and if approved likely to be a big beneficiary if the Kidney Patient Act pass's ...or some comprise is worked out with CMS .

Lets see how this post has aged if AUPH hits $12

Good luck
Kiwi

Well, just remember that I reminded you when it was even at 6 about maybe a couple of months ago.

Thx Jess but I think Lupy is still seen as " when all else fails ...try Lupkynis "
This is primarily because of its pricing and the road blocks insurers put up to try and avoid paying for it .

Benny is significantly cheaper , is a sub Q , does not allow as fast a steroid taper as Lupy ...but because its some much cheaper insurers often want patients to try that first
The drug ( Lupkynis ) faces competition from GSK’s Benlysta (belimumab), which received FDA approval slightly earlier in December 2020 and EMA approval in May 2021. Despite Benlysta being a subcutaneous treatment, it is projected to outpace Lupkynis in sales by 2030. According to GlobalData’s Pharma Intelligence Center, Lupkynis is expected to reach $447m in sales by 2030 while Benlysta is forecasted to generate $1.76bn.


AUPH has slashed payroll so major cost saving there and Tang is probably trying to get the Co ready for a sale
Good luck
Kiwi

Kiwi, time for you to take Auph seriously. You have a chance to double your money here now. You know it’s coming soon. You can try 1700 shares like Cervelo.

Not massive volume today but 2x average so not bad.  Hopefully this continues.  

Anything will help at this point RMB. My reply to your recent post about pricing flexibility is that it should have been a priority for management the minute management decided to go-it-alone.

Prescribing Lupkynis allows Nephrologists to taper steroid use faster . This is a good thing . Patients are more prone to infections , weight gain and mood swings on steroids and the patients usually hate them
Kiwi

Anyone have any thoughts on the new revised American College of Rheumatology guidelines for treatment of LN? Aurinia seems to think they are an improvement:

https://www.businesswire.com/news/home/20241118903839/en/Aurinia-Commends-2024-Updated-ACR-Guidelines-for-Screening-Treatment-and-Management-of-Lupus-Nephritis#:~:text=The%20guidelines%20call%20for%20a,acceptable%20maintenance%20dose%20of%20steroids.

Otsuka launching Lupkynis today in Japan:

https://www.otsuka.co.jp/en/company/newsreleases/2024/20241120_1.html

Hey! We were enjoying the peace and quiet here....