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Low Etanercept Doses May Be Effective in Maintaining Remission in Psoriatic Arthritis Patients – Physician’s Weekly
Posted: February 21, 2022 at 6:19 pm
For a study, researchers conducted a longitudinal open-label trial to analyze if extending the intervals between etanercept (ETN) delivery may be beneficial in sustaining remission with a steady dosage in psoriatic arthritis (PsA) patient group that has achieved persistent remission with ETN 25 mg biweekly.
Fifty-four patients with PsA were recruited from the Azienda Ospedaliera Universitaria Seneses Rheumatology Unit. Patients in clinical remission with biweekly ETN 25 mg at weeks 12 and 16 were moved to a weekly regimen. If clinical remission was maintained at weeks 24 and 28, patients were transferred to an every-other-week regimen, with this administration schedule continuing for the rest of the research if clinical remission was maintained at weeks 36 and 40. If, on the other hand, disease activity increased in one of the checks, the treatment plan was reverted to the prior one.The outcome of the study showed that a consistent percentage (72%) of patients with PsA who achieved sustained remission with ETN 25 mg biweekly maintained remission after a year of starting therapy, despite a progressive dose reduction by increasing the dosing interval, 21% with a weekly regimen and 51% with an every-other-week regimen.
Findings indicated that peripheral polyarthritis pattern and aggravation of cutaneous symptoms were the key factors preventing ETN dosage interval increase in patients with PsA in prolonged clinical remission at regular doses.
Reference:journals.lww.com/jclinrheum/Abstract/2018/04000/Low_Doses_of_Etanercept_Can_Be_Effective_to.4.aspx
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Beyond the Gut, Bifidobacterium infants 35624 Regulates Host Inflammatory Processes – Physician’s Weekly
Posted: at 6:19 pm
For a study, it was determined that certain therapeutic microorganisms, such as Bifidobacteria infantis (B. infantis) 35624, mimic commensal-immune interactions and had favorable immunoregulatory effects. However, the utility of these effects in patients with non-gastrointestinal inflammatory disorders was unknown. The researchers observed the effects of taking B. infantis 35624 orally for 6-8 weeks on inflammatory biomarker and plasma cytokine levels in patients with ulcerative colitis (UC) (n=22), chronic fatigue syndrome (CFS) (n=48), and psoriasis (n=26) in 3 separate randomized, double-blind, placebo-controlled interventions. The impact of B. infantis 35624 on immunological indicators in healthy persons (n=22) was also investigated. Comparable to healthy volunteers, both gastrointestinal (UC) and non-gastrointestinal (CFS and psoriasis) patients exhibited significantly higher plasma levels of C-reactive protein (CRP), as well as the pro-inflammatory cytokines tumor necrosis factor (TNF-) and interleukin-6 (IL-6). Comparable to placebo, B. infantis 35624 feeding resulted in lower plasma CRP levels in all three inflammatory illnesses. In CFS and psoriasis, plasma TNF - was lowered, whereas IL-6 was reduced in UC and CFS. Furthermore, after eight weeks of feeding, LPS-stimulated TNF - and IL-6 release by peripheral blood mononuclear cells (PBMCs) in healthy subjects was significantly reduced in the B. infantis 35624-treated groups compared to placebo. According to the findings, this microorganism can lower systemic pro-inflammatory biomarkers in gastrointestinal and non-gastrointestinal disorders. Finally, it was revealed that the microbiotas immunomodulatory effects in humans were not restricted to the mucosal immune system, but also extend to the systemic immune system.
Link:www.tandfonline.com/doi/full/10.4161/gmic.25487
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AbbVie Snags FDA Approval for Another Indication. Will It Become Another Blockbuster? – Motley Fool
Posted: at 6:19 pm
AbbVie ( ABBV -0.65% ) has taken an important step toward replacing the revenue decline that will result from Humira's patent protection expiration in the U.S. next year.
That step is approval from the U.S. Food and Drug Administration (FDA) to use AbbVie's Skyrizi to treat patients with active psoriatic arthritis, a disease that impacts around 1.5 million Americans.
Let's dive into the phase 3 clinical trial results for Skyrizi and the U.S. psoriatic arthritis market to get a feel for how valuable this approval could be for AbbVie.
Image source: Getty Images.
Psoriatic arthritis is a type of inflammatory arthritis that occurs when the immune system attacks healthy tissue. This can cause joint pain, stiff joints, and fatigue. If psoriatic arthritis is left untreated for long enough, the condition can result in irreversible joint damage.
One treatment option that could now make a difference in the lives of countless psoriatic arthritis patients is Skyrizi, which works by controlling the release of interleukin-23 (IL-23) proteins, a different method than other drugs on the market.
AbbVie conducted two phase 3 clinical trials with patients who weren't able to achieve meaningful improvement or were unable to tolerate biologic therapies or non-biologic disease-modifying anti-rheumatic drugs. Tumor necrosis factor (TNF) inhibitors like AbbVie's blockbuster Humira are often the first-line therapy for psoriatic arthritis patients. While this drug class is highly effective in treating patients, it doesn't work for everyone. In fact, 19% of patients on TNF inhibitors don't greatly benefit from taking them. Those patients could benefit from Skyrizi.
Up to 57% of patients taking Skyrizi experienced at least a 20% improvement in their tender/swollen joint count and pain scale at week 24. This was statistically superior to the 34% of patients receiving placebo who experienced similar levels of improvement.
The maximum rate of serious adverse events in patients taking Skyrizi across both clinical trials was just 4%, which was lower than the placebo rate of 5.5%. This demonstrates Skyrizi to be safe and effective.
Since Skyrizi will mostly be prescribed to patients who didn't experience improvement on TNF inhibitors, I think the drug's biggest strength is its safety profile. Unlike Janus kinase (JAK) inhibitors like Pfizer's (NYSE: PFE) Xeljanz and Eli Lilly's (NYSE: LLY) Olumiant, which come with increased risk of heart attack, cancer, and blood clots, Skyrizi hasn't been found to elevate the risks of these events. That should allow Skyrizi to be prescribed ahead of JAK inhibitors, which will lead to greater market share.
Sykrizi looks like it will be a game-changer for many psoriatic arthritis patients. But how much of a growth catalyst could the indication be for AbbVie?
The Johns Hopkins Arthritis Center estimates that psoriatic arthritis impacts around 1.5 million Americans. If you consider that 19% of psoriatic arthritis patients don't benefit from TNF inhibitors, that would put approximately 285,000 patients in a group that need alternative treatments.
Due to Skyrizi's exceptional safety profile and efficacy, my guess is that the drug can seize 10% of the market or about 28,500 psoriatic arthritis patients in a base-case scenario. Skyrizi has an annual list price of $73,000. Negotiations with health insurance companies and drug assistance programs for eligible patients mean that the net price will be significantly cheaper than the list price. I estimate the annual net price could be $40,000 per patient. Below is a range of market shares using that $40,000 that demonstrates the blockbuster potential of the drug.
My estimate of 10% market share at $40,000 annual cost would lead to over $1.1 billion in annual sales potential for Skyrizi. Against the $60.3 billion in sales analysts expect for AbbVie this year, this would be a 1.9% bump in total revenue. For Skyrizi, $1.1 billion in additional sales would be a nearly 40% boost over the $2.9 billion in revenue that the drug generated last year.
Skyrizi's psoriatic arthritis indication could be a slight growth catalyst for AbbVie as a whole. But it will be a huge boost for the the drug since it is Skyrizi's second approved indication.
Aside from Skyrizi, AbbVie has dozens of drug indications that are in different stages of development. AbbVie's next-generation immunology drugs Skyrizi and Rinvoq each have indications for Crohn's Disease and ulcerative colitis that are either in phase 3 clinical trials or that have already been submitted to regulatory authorities.
Approval could add up to billions of dollars in annual sales and could be approved this year or next year. Thanks to recent regulatory approvals and more that are expected to come, AbbVie believes that Skyrizi and Rinvoq will generate more than $15 billion in combined sales by 2025. This would be more than triple the $4.59 billion in combined sales that the two drugs produced last year. Factoring in a 50%, or nearly $9 billion, decline in Humira's U.S. sales by 2025 from biosimilar drug competition starting next year, Skyrizi and Rinvoq should be enough to replace the revenue loss from Humira. Analysts are expecting 4% annual earnings growth over last year in the next five years.
AbbVie's 41% dividend payout ratio last year and decent growth prospects should lead to strong dividend growth in the future and investors can getAbbVie's 4% dividend yield at a current price-to-earnings ratio of 10. This makes AbbVie a stock to consider buying right now.
This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis even one of our own helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.
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Apple Employees Are Unionizing and They’re Using Android Phones to Keep Apple From Spying on Them – Futurism
Posted: at 6:03 pm
Who wants to be spied on at work!?Big Brother
The labor movement has finally made its way to Apple. According to the Washington Post, retail employees at the tech giant are beginning to quietly unionize, in part because hourly wages have remained stagnant while Apples profit margins soar.
Two store locations are preparing to file paperwork with the National Labor Relations Board(NLRB) and a half dozen more are in earlier stages, said employees who spoke to WaPo on the condition of anonymity (full disclosure: this reporter spent several years working at several Apple retail locations). One particularly telling detail, according to WaPo: suspicious of snooping by Apple, many organizers have switched to Android phones to avoid any potential spying.
Thatmight sound alarmist, but in 2021 Apple fired an employee named Ashley Gjvikwho alleged sexual harassment, environmental concerns and surveillance at the company.
The megacorporation has an internal culture of surveillance, intimidation, and alienation, she wrote. Employees are closely monitored and our data hoarded in the name of secrecy and quality.
And in 2011, Wired reported that Apple employees allegedly posed as fake police officers during an apartment raid in order to recover an iPhone prototype.
Of course, its not clear whether Apple is actually spying on organizers iPhones and if it got caught doing so, it would likely get in huge trouble with regulators.
In any case, lets hope not. Employees have the right to organize, and they should be able to do so without the fear of corporate surveillance.
More on creepy overreaches: Facebook Reveals Plan to Plaster AR Ads Over All of Reality
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Thousands of People Say They’re Going to Throw Eggs at Jeff Bezos’ Superyacht – Futurism
Posted: at 6:03 pm
"Take a box of rotten eggs with you and lets throw them en masse at Jeffs superyacht."Good Eggs
Tesla CEO Elon Musk isnt the only one who likes to take aim at Amazon founder Jeff Bezos.
Residents in the Dutch city of Rotterdam are planning to christen Bezos new superyacht which is being built near the city the only way they see fit: by hurling rotten eggs at it.
Nearly 5,000 people have RSVPd to the event on Facebook at the time of reporting,and more than 16,000 have marked themselves as interested.
Calling all Rotterdammers, the events description reads, take a box of rotten eggs with you and lets throw them en masse at Jeffs superyacht when it sails through the Hef in Rotterdam.
The trouble seems to largely stem from Bezos demands that the Hef, the nickname for the historic Koningshavenbrug bridge in Rotterdam, be disassembled and then reassembled so that his $485 million boat can be taken out to sea. The mayor of the city says its the only route to the sea, according to Agence France-Presse.
Bezos has agreed to help foot the bill for temporarily disassembling the 145-year-old bridge, which provides just 131 feet of clearance, according to Dutch broadcaster Rijnmond. But thats apparently not enough for the Blue Origin CEOs critics.
Normally, its the other way around, Pablo Strrmann, Rotterdam resident and organizer of the Facebook event, told The NL Times. If your ship doesnt fit under a bridge, you make it smaller but when you happen to be the richest person on Earth, you just ask a municipality to dismantle a monument. Thats ridiculous.
More on Bezos boat: Jeff Bezos Demands That Historic Bridge Be Taken Apart So That His Superyacht Can Pass Through
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Microdosing Acid Doesn’t Have Any Benefits, Say Scientists With No Sense of Fun – Futurism
Posted: at 6:03 pm
There are apparently some drug researchers who hate fun and think that microdosing psychedelics has no benefits.
A new study, published in theAddiction Biology journal, claims that there are no cognitive or performance-ehancing effects in participants who took small amounts commonly known as microdoses of lysergic acid diethylamide (LSD).
Researchers at the University of Chicago who, its perhaps worth noting, got funding from the National Institute on Drug Abuse and the National Institute of Health conducted a double-blind controlled study with one group that actually took acid and one that took a placebo at three or four-day intervals.
Respondents reported feeling a drug effect from the active dosages, which, as one Twitter user noted, appeared to be slightly above the average microdose. Though the study admitted that repeatedly taking such low doses were safe for healthy volunteers, they neverthelessfound that the practiced produced negligible changes in mood or cognition.
This study, to be clear, isnt very surprising if addiction researchers are looking narrowly into whether or not microdosing is dangerous and/or beneficial, theyre not likely to find anything compelling in either direction.
While microdosing acid and psilocybin mushrooms have become hugely popular over the last decade, the fact remains that psychedelic drugs have traditionally been used either for spiritual or existential experiences or, of course, tohave some fun.If they increase productivity or creativity at work, thatd be great, but there are a lot of other valid reasons to pop a tab.
This finding may suggest that LSD doesnt hack your brain into being more productive, in other words, but at least its safe.
READ MORE:Repeated low doses of LSD in healthy adults: A placebo-controlled, doseresponse study [Addiction Biology]
More on microdosing:Silicon Valley CEO Fired for Microdosing LSD at Work
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Facebook Reveals Plan to Plaster AR Ads Over All of Reality – Futurism
Posted: at 6:03 pm
That just sounds awful.Zoom In
In a Zoom call with ad agencies on Thursday, Meta outlined the way mixed reality, or MR, can be used to sell products according to a Reuters report. The publication interviewed an agency executive who attended the first roundtable discussion Meta has held with advertisers.
Advertisers are also looking for detail on how the effectiveness of ads in the metaverse will be measured, and will be asking what did I get for my money?' the executive told Reuters.
MR is really the marriage of the real world and either virtual or augmented reality. Games like Pokmon Go qualify as augmented reality because they allow players to imagine the magical creatures in normal surroundings with the use of a smart phone. Virtual reality headsets obviously immerse users in a digital world, but Meta, formerly called Facebook, wants virtual content to interact with real world objects.
For example, companies might be able to plaster ads on real life objects, allow users to virtually try on clothes or interact with sellable products in other digital ways. But according to Reuters,Meta was short on details about how the tech will actually work or how agencies will be able to sell stuff with it.
Its a little grim how badly advertisers want to capture everyones attention, and it seems theyll go to increasingly extreme lengths to get it. Just last week the previously bankrupted MoviePass app announced its return, and it features eye-track tech that rewards you for watching ads in their entirety. Thats after the same MoviePass CEO started using the tech back in 2019 for a different startup.
In 2021, ad agency Marketing Insider Group published a report stating that digital ads just dont work anymore, and that even after slashing ad budgets some giant companies didnt see a decline in sales. Its surely part of the reason agencies are scrambling to come up with new ideas, no matter how invasive. At least with Meta its possible consumers just wont buy an MR headset, and thus avoid extra ads plastered into their lives.
More on scary ads: Grindr Slammed With Huge Fine for Spying on Users
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Economist Mocked for Proposing That We Sell the Moon – Futurism
Posted: at 6:03 pm
"Economist brain is a devastating affliction."Land Rush
Its currently not allowed for any one country to lay claim to property in outer space, but thats not stopping one economic think tank from pushing for lunar property sales.
In a paper titled Space Invaders: Property Rights on the Moon published by the Adam Smith Institute (or ASI, named for the British philosopher known for claiming that free markets are guided by an invisible hand), economist Rebecca Lowe argues that the Moon should be split up among the nations of Earth, which would then rent or sell them to boost the economy.
The eyebrow-raising premise earned widespread mockery online.
Lowe acknowledges that the ownership of space propertyis currently outlawed by long-standing international treaty, a reference to the United Nations Outer Space Treaty (OST) of 1967.
But thats too old school for Lowe, who argues in the paper that as commercial space travel becomes more common, so too should lunar real estate. She goes even further, arguing against an approach based on international consensus like the one that created the OST, instead offering an individualistic approach.
The idea would be to portion the Moon off in a scheme that sounds a lot like the Berlin Conference that split up the African continent among European nations in 1884. Each government would figure out how to make the sale of their plot of moon land fair, via what Lowe mused could involve tenders, shareholder schemes, other market mechanisms, lotteries, or various types of state-determined allocation.
It remains a bit hazy who, exactly, would be in charge of portioning off lunar property rights, though Lowe does admit dozens of pages of property theory later that the scheme is built on individual nations [competing] against each other for plots of land on the Moon.
The scheme does make some sort of abstract sense, though it takes very little critical thinking to recognize that if the global community actually decided to do something like this, it would almost certainly result in conflict.And thats without getting into the fact that we barely have any understanding of which parts of the Moon, if any, would actually be valuable.
There may well come a time when we have to figure out who gets to own the Moon. But until then, lets hope some smarter people come up with better schemes than this one.
READ MORE:Space Invaders: Property Rights on the Moon [The Adam Smith Institute]
More on the Moon: Ridiculous Analysis Claims You Could Build a House on the Moon for $60 Million
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98-Year-Old Billionaire Says It’s Fine to Pack Young People in Windowless Rooms Like Rats – Futurism
Posted: at 6:03 pm
"Like, how is this legal?"Of Mice and Munger
Billionaire Charlie Munger has no problem with college students not seeing the sun for days. He describes his windowless dorms as being a mouse trap and believes the design will be copied all over the country, according to a new CNN Business report following one of Mungers annual business calls on Wednesday.
Munger, who has no formal architectural training, donated $110 million in 2013 to his alma mater the University of Michigan to help fund a $185 million dorm building, according to previous CNN reporting. The Munger Graduate Residence Hall houses about 600 graduate students in 6 to 7 bedroom apartments and,notably, he insisted that most of the single-occupancy rooms not have windows.
In fact, public policy graduate student Luiza Macedo says she didnt see the sun for an entire week while on COVID-19 lockdown, isolated in her room.
That was probably the low point of my experience here. It was being stuck in my room, Macedo told CNN. Like, how is this legal? How are they doing this to us?
Even though Mungers architect quit the project before the building was finished, Munger stood by the eccentric request in that 2021 report, and brought it up again in an annual sales call this week. He says he hopes more windowless dorms will be built soon.
I do expect this dorm will be copied I expect this to spread all over the country, Munger, who is known as billionaire Warren Buffets right hand man, told CNN in 2021. Its a better mouse trap.
Munger sounds like a weird guy. He wants his miserable college dorms copied even though, in his literal own words, he is ready to die very shortly. He also seemingly defended Chinas one-child population policy this week, saying that the communist government there helped reduce its population problem.
Its not really clear why a 98-year-old who doesnt think he has much time left is so invested in Chinas population, never mind promoting depressing windowless caves for young people.
Munger, who also hates crypto and the blockchain with a passion, has been calling the shots for Warren Buffets giant conglomerate for decades, so maybe he still doesnt get that you cant take it with you when you go. Or maybe hes just trying to squeeze every red cent out of the world that he can before its too late although, of course, college students will be forced to live in his buildings long after hes gone.
More on rich folks shenanigans: Billionaire Space Tourist Buys Three More SpaceX Launches in Shocking Display of Wealth
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Kanye West Says His Next Album Will Only Be Available on a Strange, Orb-Shaped Device – Futurism
Posted: at 6:03 pm
$200 for a Walkman!?Hard Pressed
Artists releasing albums via NFTs must be a thing of the past because musician Ye, the artist formerly known as Kanye West, told fans via Instagram on Thursday that his new album Donda 2 will only be available via a small proprietary contraption called the Stem Player.
After deleting everything from his Instagram profile over feedback about his disturbing posts about his ex-wife Kim Kardashian, West went on a 16-hour-long tirade, stretched over 14 new Instagram posts promoting the new album.
The Stem Player made its debut last year, according to The Verge, and reportedly works pretty well despite its unusual appearance. About that: the player itself is rounded and looks a bit like squashed smoke detector, a stark departure from conventional music hardware.
Colored light sliders move in four directions as music plays and thats not even the strangest thing about the gadget.
The simple website for the album includes a few more details. The player will ship with Donda 2 locally stored. According to The Verge, the device has a measly eight gigabytes of storage, a USB-C port, Bluetooth, a headphone jack, and a surprisingly powerful speaker.
The most interesting aspect is probably that itll allow users to customize the mix of each song, whichll be broken down into component tracks like drums, bass, and vocals.
On the one hand, thats a pretty bold vision for the future of consumer music. On the other, though, its moderately ridiculous to think fans will have to carry the 21st century equivalent of a HitClips audio player from the 1990s with them to listen to the album.
The Stem Player might be a fun gadget if it wasnt the only way listeners could get to listen to the new album. According to West, Donda 2 will not be released via Spotify or Apple Music, because the billionaire wouldnt get a high enough percentage of the profits.
Today artists get just 12% of the money the industry makes, he wrote in a post on Instagram. Its time to free music from this oppressive system. Its time to take control and build our own.
Oh, and did we mention that the tiny device costs $200?
All told, well probably pass, especially given the recent recent and serious allegations of abusive behavior by West.
Maybe another artist will do something cool with a similar device in the future. In the meantime, it looks like plenty of people plan to pirate the new album instead of paying up anyway.
More on pop culture weirdness: In Bizarre Ad, Facebook Imagines Its Users As Robot Dogs Stuffed Into Trash Compactors
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