Health
Treating Rheumatoid Arthritis With a Biologic: Risks and Benefits
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There was a time, not very long ago, when a diagnosis of rheumatoid arthritis guaranteed a life of pain and disability. While there still isn’t a cure, the outlook is much brighter.
“[Things] have definitely changed for the better,” says Beth Jonas, MD, a rheumatologist with the University of North Carolina’s Thurston Arthritis Research Center.
Medications called biologic response modifiers — or biologics — have turned the tables. The use and ongoing development of these drugs have given people with RA — and their doctors — hope.
“It is very unusual now, in the year 2017, for me to have [someone] that I just can’t treat,” Jonas says. “I can’t tell you how great that feels. It’s a world of difference from just 20 years ago, before biologics.”
Treatment for RA has come a long way since the days of bloodletting and leeching — the gold standards of care many decades ago.
In the 1930s, doctors used actual gold to treat patients with RA. These injections were part of a group of drugs called disease-modifying anti-rheumatic drugs. You probably know them as DMARDs.
Gold compounds aren’t used much these days. Since the 1990s, the cornerstone of RA treatment plans has been a DMARD called methotrexate. Instead of directly treating pain and symptoms, they go after the underlying disease. By doing that, Jonas says, folks have less inflammation, pain, and damage.
“Methotrexate was a real game changer. It got people up and moving,” she says.
Some, she adds, not all. Jonas says about half of folks with RA got going.
Over time, researchers got a better grasp of how the disease works in your body. That led to the discovery of new parts of the body to focus on, and the development of biologics.
These biologic DMARDs are genetically engineered proteins made from human genes. They’re designed to target parts of your immune system that drive inflammation.
They do so with a sniper’s aim.
Guy Eakin, senior vice president for scientific strategy at the Arthritis Foundation in Atlanta, says that’s a big change from non-biologic drugs like methotrexate, which fight RA with more of a sledgehammer-like approach.
“The greatest advantage of using biologics to treat rheumatoid arthritis is that they can be exquisitely targeted to a specific player in our body’s immune system,” he says.
One of the key issues with traditional, oral DMARDs like methotrexate is they take weeks to months to work. Not so with biologics.
“Meanwhile, biologics gave us a tool that was potent and fast, and their ability to prevent joint damage is better,” Jonas says. “What we have learned over time is that a combination of biologics and methotrexate works better than either one alone.”
Etanercept (Enbrel) was the first biologic to be approved by the FDA. Since that approval in 1998, there are now at least eight more biologics for RA.
The first ones were known as anti-TNF agents. In other words, they block a substance called tumor necrosis factor. TNF causes joint inflammation and destruction.
When your doctor decides to go the biologics route, you’ll usually get TNF inhibitors first.
But what if your RA has nothing to do with TNF?
“Predicting the right drug can be tricky,” Jonas says. “Most of our first choices are TNF inhibitors, but we might have to switch to biologics with different mechanisms.”
Other biologics used to treat RA include:
Abatacept: Blocks communication between inflammatory T cells (those are a type of white blood cell)
Anakinra: Hampers the protein interleukin-1, a major culprit in inflammation
Baricitinib: A JAK inhibitor that tamps down inflammation
Rituximab: First used to fight non-Hodgkin’s lymphoma, this destroys white blood cells that help cause inflammation.
Sarilumab: An antibody that blocks the interleukin-6 receptor, known to cause inflammation
Tocilizumab: Targets interleukin-6, an immune system protein that fuels inflammation
Tofacitinib is almost in a class by itself. You can take it by mouth. It inhibits enzymes that help cause inflammation.
When thinking about the biologic big picture, Eakin thinks of an adage from the “Spider-Man” movies: “With great power comes great responsibility,” he says.
“When we talk about RA, what we’re actually doing with biologics is turning off part of the immune system. Or, more broadly, we are manipulating the immune system.”
The best strategy is to talk with your doctor about the different side effects associated with each drug.
“The biggest risk with this whole class of biologic drugs is infection,” Jonas says. That’s because of the changes the drugs make to your immune system.
There have been other concerns. The FDA issued a warning in 2009 that there is an increased chance of cancer in kids and teens who use biologics to treat juvenile arthritis. But, Eakin notes, there’s also a risk from other drugs used to treat the same thing.
“When you look back at billing records from the last 15 years, you can see that the cancer risk is similar for kids taking biologics versus those who aren’t,” he says.
The biggest hurdle with biologics is the price.
“The expense is crazy, the cost is high,” Jonas says.
Some relief may come with a new line of drugs called biosimilars, which will be entering the marketplace soon.
According to the Arthritis Foundation, biosimilars “have the potential to provide safe and effective treatment to people with arthritis at a significantly lower cost than name-brand biologic medications.”
But make no mistake. Biosimilars are definitely not generic versions of biologics.
Generic drugs are copies of brand-name drugs, with the same active ingredient, the same everything: dosage, safety, strength, etc.
Biosimilars are just what the name implies. They’re similar to the biologic they’re based on, but, because they’re made from living organisms, there are acceptable differences. In terms of safety, potency, and purity, they have no meaningful clinical differences from the biologic.
“Biosimilars are different from biologics in very nuanced ways,” Eakin says. “But, by and large, they are considered identical to one another.”
The estimated cost reduction for a biosimilar is 15% to 20%.
Whatever the cost, the basic rule when treating RA with biologics is, the earlier, the better.
“We know that the longer you have RA, the more likely you’ll have joint damage, so the key is to get started before that happens,” Jonas says. “And when the timing works out, the results are sort of amazing.”
Health
Walmart Is Selling a $300 Power Tower for Just $128, and Shoppers Say It's 'Surprisingly Sturdy'
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When building a home gym, it’s easy to get overwhelmed by all the equipment options, especially when you’re working with limited space and a tight budget. But when you focus on versatile gear and hunt for deals, creating a useful setup is easily doable. Thankfully, Walmart has been slashing prices on a ton of fitness equipment, including its bestselling adjustable dumbbells and even a complete home gym system. Now, it’s reduced the price of a popular power tower by over $170, and it even ships for free.
The Pooboo Body Champ Multifunction Power Tower is on sale for $128, a 57% discount on its normal price of $300. This incredibly versatile workout station has earned nearly 250 five-star ratings from Walmart shoppers who’ve praised its “strong and sturdy” build and “quality fit and finish,” and it’s currently one of the top 5 bestselling models on the site.
Pooboo Body Champ Multifunction Power Tower, $128 (was $300) at Walmart
Don’t let the brand’s bizarre name fool you—this power tower is a well-made piece of gym equipment. It features steel construction and is rated to hold up to 480 pounds (the tower itself weighs 66 pounds). A nearly 42-inch H-shaped base gives it excellent stability, so it won’t wobble or shake when you’re exercising, and anti-slip feet on the bottom keep it securely planted on the floor. It’s also adjustable (from 71.4 inches to 94 inches) to accommodate users of varying heights. And, once it’s set up, you can use it for a huge range of exercises, including dips, pull-ups, chin-ups, push-ups, vertical leg raises, knee raises, and more.
According to Walmart reviewers, the Pooboo Body Champ stands out for its solid build and usefulness. “It’s a surprisingly sturdy piece of equipment,” a shopper said. “Everything about this fitness tower is perfect. I originally purchased this with the intention of only doing pull-ups on it, but after quickly assembling the power tower, I came to realize just how versatile it is. It has cushions for knee and leg raises, it’s sturdy, and the perfect width for dips.” Another shopper agreed, saying, “This was a much-needed addition to my home gym.”
“This thing is amazing and worth every penny,” said another, who added that it’s “easy to install and can hold a lot of weight.”
At just $128, this Pooboo power tower is a screaming deal, and it’s sure to get lots of use during your workouts. But this discount won’t last long, so grab one today before the price pumps back up.
Health
Alzheimer’s Drug May Save Lives Through ‘Suspended Animation’
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By Lindsay Brownell | Wyss Institute Communications | Harvard Gazette
Could buy patients more time to survive critical injuries and diseases, even when disaster strikes far from a hospital
Donepezil, an FDA-approved drug to treat Alzheimer’s, has the potential to be repurposed for use in emergency situations to prevent irreversible organ injury, according to researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University.
Using Donepezil (DPN), researchers report that they were able to put tadpoles of Xenopus laevis frogs into a hibernation-like torpor.
“Cooling a patient’s body down to slow its metabolic processes has long been used in medical settings to reduce injuries and long-term problems from severe conditions, but it can only currently be done in a well-resourced hospital,” said co-author Michael Super, director of immuno-materials at the Wyss Institute. “Achieving a similar state of ‘biostasis’ with an easily administered drug like DNP could potentially save millions of lives every year.”
This research, published Thursday in ACS Nano, was supported as part of the DARPA Biostasis Program, which funds projects that aim to extend the time for lifesaving medical treatment, often referred to as “the Golden Hour,” following traumatic injury or acute infection. The Wyss Institute has been a participant in the Biostasis Program since 2018, and has achieved several important milestones over the last few years.
Using a combination of predictive machine learning algorithms and animal models, the Wyss’ Biostasis team previously identified and tested existing drug compounds that had the potential to put living tissues into a state of suspended animation. Their first successful candidate, SNC80, significantly reduced oxygen consumption (a proxy for metabolism) in both a beating pig heart and in human organ chips, but is known to cause seizures when injected systemically.
In the new study, they once again turned to their algorithm to identify other compounds whose structures are similar to SNC80. Their top candidate was DNP, which has been approved since 1996 to treat Alzheimer’s.
Achieving a similar state of ‘biostasis’ with an easily administered drug like DNP could potentially save millions of lives every year.
–Michael Super
“Interestingly, clinical overdoses of DNP in patients suffering from Alzheimer’s disease have been associated with drowsiness and a reduced heart rate — symptoms that are torpor-like. However, this is the first study, to our knowledge, that focuses on leveraging those effects as the main clinical response, and not as side effects,” said the study’s first author, María Plaza Oliver, who was a postdoctoral fellow at the Wyss Institute when the work was conducted.
The team used X. laevis tadpoles to evaluate DNP’s effects on a whole living organism, and found that it successfully induced a torpor-like state that could be reversed when the drug was removed. The drug, however, did seem to cause some toxicity, and accumulated in all of the animals’ tissues. To solve that problem, the researchers encapsulated DNP inside lipid nanocarriers, and found that this both reduced toxicity and caused the drug to accumulate in the animals’ brain tissues. This is a promising result, as the central nervous system is known to mediate hibernation and torpor in other animals as well.
Although DNP has been shown to protect neurons from metabolic stress in models of Alzheimer’s disease, the team cautions that more work is needed to understand exactly how it causes torpor, as well as scale up production of the encapsulated DNP for use in larger animals and, potentially, humans.
“Donepezil has been used worldwide by patients for decades, so its properties and manufacturing methods are well-established. Lipid nanocarriers similar to the ones we used are also now approved for clinical use in other applications. This study demonstrates that an encapsulated version of the drug could potentially be used in the future to buy patients critical time to survive devastating injuries and diseases, and it could be easily formulated and produced at scale on a much shorter time scale than a new drug,” said senior author Donald Ingber, the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and the Hansjörg Wyss Professor of Bioinspired Engineering at Harvard’s John A. Paulson School of Engineering and Applied Sciences.
This research was supported by DARPA under Cooperative Agreement Number W911NF-19-2-0027, the Margarita Salas postdoctoral grant co-funded by the Spanish Ministry of Universities, and the University of Castilla-La Mancha (NextGeneration EU UNI/551/2021).
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This story is reprinted with permission from The Harvard Gazette.
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Health
Can Stuff in Rosemary Extract Fight Cocaine Addiction?
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Researchers have discovered that an antioxidant found in rosemary extract can reduce intakes of cocaine by moderating the brain’s reward response, offering a new therapeutic target for treating addiction.
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The study in the journal Neuron describes researchers’ focus on a region of the brain called the globus pallidus externus, which acts as a gatekeeper that regulates how we react to cocaine.
They discovered that within the GPe, parvalbumin-positive neurons are crucial in controlling the response to cocaine by changing the activity neurons releasing the pleasure molecule dopamine.
“There are currently no effective therapeutics for dependence on psychostimulants such as cocaine, which, along with opioids, represent a substantial health burden,” says corresponding author Kevin Beier, an associate professor of physiology and biophysics at the University of California, Irvine.
“Our study deepens our understanding of the basic brain mechanisms that increase vulnerability to substance use disorder-related outcomes and provides a foundation for the development of new interventions.”
Findings in mice revealed that globus pallidus externus parvalbumin-positive cells, which indirectly influence the release of dopamine, become more excitable after being exposed to cocaine. This caused a drop in the expression of certain proteins that encode membrane channels that usually help keep the globus pallidus cell activity in check. The researchers found that carnosic acid, an isolate of rosemary extract, selectively binds to the affected channels, providing an avenue to reduce response to the drug in a relatively specific fashion.
“Only a subset of individuals are vulnerable to developing a substance use disorder, but we cannot yet identify who they are. If globus pallidus cell activity can effectively predict response to cocaine, it could be used to measure likely responses and thus serve as a biomarker for the most vulnerable,” Beier says. “Furthermore, it’s possible that carnosic acid could be given to those at high risk to reduce the response to cocaine.”
The next steps in this research include thoroughly assessing negative side effects of carnosic acid and determining the ideal dosage and timing. The team is also interested in testing its efficacy in reducing the desire for other drugs and in developing more potent and targeted variants.
Scientists from the University of West Virginia and the University of Colorado participated in the study.
Support for this work came from the National Institutes of Health, One Mind, the Alzheimer’s Association, New Vision Research, BrightFocus Foundation, and the Brain & Behavior Research Foundation.
Source: UC Irvine
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Previously Published on futurity.org with Creative Commons License
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