Walking Reduces Pain From Knee Osteoarthritis

By Pat Anson, PNN Editor

It may seem counterintuitive, but a new study suggests that walking may be the best medicine to reduce knee pain from osteoarthritis.

Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis, a progressive joint disorder caused by inflammation of soft tissue, which leads to thinning of cartilage and joint damage. Osteoarthritis (OA) of the knee is not to be taken lightly, as studies have found that it is strongly associated with early death, high blood pressure, diabetes, elevated cholesterol and cardiovascular disease, particularly for women.

Moderate exercise like walking may help prevent all of those health problems.

In a multi-year study of 1,212 people over the age of 50, researchers at Baylor College of Medicine found that participants who walked for exercise at least 10 times had 40% less risk of developing frequent knee pain than non-walkers.

“Until this finding, there has been a lack of credible treatments that provide benefit for both limiting damage and pain in osteoarthritis,” said Grace Hsiao-Wei Lo, MD, assistant professor of Immunology, Allergy and Rheumatology at Baylor and lead author of the study published in Arthritis & Rheumatology.

“These findings are particularly useful for people who have radiographic evidence of osteoarthritis but don’t have pain every day in their knees,” Lo explained in a press release. “This study supports the possibility that walking for exercise can help to prevent the onset of daily knee pain.  It might also slow down the worsening of damage inside the joint from osteoarthritis.”  

Lo says walking for exercise has other health benefits, such as improved cardiovascular health and decreased risk of obesity, diabetes and even some cancers. Walking is also a free activity with minimal side effects.

“People diagnosed with knee osteoarthritis should walk for exercise, particularly if they do not have daily knee pain,” says Lo, who is chief of rheumatology at the Michael E. DeBakey VA Medical Center in Houston. "If you already have daily knee pain, there still might be a benefit, especially if you have the kind of arthritis where your knees are bow-legged.”

FTC Sues Footwear Company Over Pain Relief Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission has filed a lawsuit against a California footwear company, alleging it makes false claims that its shoes can relieve knee, back and foot pain. It’s the latest salvo in a long-running legal battle between the FTC and the Gravity Defyer Medical Technology Corporation.

According to the FTC complaint, Gravity Defyer and its owner, Alexander Elnekaveh, violated a 2001 order barring him from using deceptive advertising that makes unsupported scientific claims. The FTC says the company’s ads target people aged 55 and older, telling them its “pain defying footwear” made with “hybrid VersoShock technology” can relieve suffering from arthritis, joint pain, plantar fasciitis and heel spurs.

“Ignoring a prior Commission order, Gravity Defyer and its owner used false pain-relief claims to target older Americans and undercut honest competitors,” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “Health-based claims require science-based proof, and faking it by misusing studies and customer reviews breaks the law.”

The 2001 FTC order stems from another company operated by Elnekave, which sold a magnetic fuel-line device that allegedly could reduce gasoline consumption by as much as 27 percent. The FTC says those claims were false and misleading.

Gravity Defyer sells an expensive line of athletic shoes, casual shoes, dress shoes, hiking shoes, boots and sandals for men and women.

They range in price from $140 for a pair of sandals to $235 for work boots.

The company sells the shoes on its website, Amazon and at retailers around the country, including The Walking Company, Hammacher Schlemmer, and Shoe City. It advertises its products on Arthritis Today and WebMD, as well as numerous other publications and websites.

Asked to comment on the FTC complaint, the company sent a statement to PNN claiming that its First Amendment right to free speech was being violated.

GRAVITY DEFYER AD

“Gravity Defyer apprised the FTC of the obvious logical flaws in its stance – and that its stance violates Gravity Defyer’s First Amendment right to disseminate, and consumers’ right to receive, truthful, non-misleading scientific information. The FTC was unrelenting in its strange position,” the company said.

In April, Gravity Defyer filed a lawsuit of its own against the FTC. Much of it hinges on a small 2017 study that the company has long used to justify its pain-relieving claims. The study, recently published the Journal of the American Podiatric Association, found that Gravity Defyer’s “shock-absorbing sole” reduces knee pain an average of 85 percent, significantly better than traditional soles.

The FTC says the study has “substantial flaws” because of its small size (52 participants) and duration (5 weeks), and because it relied on participants’ self-reported pain levels.

“It was also only designed to measure knee pain. Thus, the study was not sufficient to determine the effects of wearing Gravity Defyer’s footwear on knee, back, ankle or foot pain, or pain associated with the specific conditions claimed,” the FTC said.

The Commission, which voted 4-0 to file the complaint, is seeking an order permanently barring Gravity Defyer and Elnekaveh from making misleading or deceptive pain-relief claims, as well as civil penalties.

My Botched Anesthesia During Surgery

By Victoria Reed, PNN Columnist

Have you ever had elective surgery that didn’t go as planned, but instead caused more pain? Did it make you think twice about having surgery again?

Having a chronic illness means that some surgeries are necessary to improve quality of life. People suffering from rheumatoid arthritis (RA) often end up having surgeries, as joint pain and deformity are common complications. Surgeries can include joint replacement or removal of rheumatoid nodules -- subcutaneous lumps or masses that can attach to underlying tissue.

Nodules are associated with more severe forms of RA and usually occur near elbow joints or joints of the hands and feet. About 20% of RA patients suffer from these nodules, which usually aren’t painful, but can cause complications.

I am one of the 20% of RA patients who has developed these nodules. Years ago, I had one growing on the underside of my right big toe. It grew so large that it was causing pain, and I was having trouble walking on that foot. I was compensating for the discomfort by using just the outside of my foot, so I consulted with a podiatrist to talk about having the nodule removed.

The doctor advised me that it could be surgically removed, but also that it could possibly grow back over time. Considering that it was affecting my ability to walk comfortably, I decided to go ahead with the surgery.

For some reason, the doctor did not want to use general anesthesia during the surgery and opted for local injections of an anesthetic to numb the toe.  This did not go well for me. As the surgical assistant injected the medication, he must have hit a nerve because it caused some of the most excruciating pain of my life! It was more painful than childbirth. As I screamed in pain, he injected the toe THREE more times, each one being equally painful.

Needless to say, that was a very traumatic experience, but the toe was indeed numb enough to cut into. After the nodule was removed, which was described in the pathology report as a “wad of gum” type of mass, I was sent home to recover, hopeful that the toe would be as good as new.

It wasn’t.

As the anesthetic wore off, I realized that I had no feeling in the toe. I called the office and inquired as to why I still had no feeling in it and was told to give it time. They assured me that the sensation would eventually return. A week passed, then another week, and still there was no feeling in parts of the toe. Other parts had a new and strangely painful tingling sensation. I called the office again and was told to allow more time for full sensation to return.

Nine years have passed and there has been no improvement. I suffer from sharp, stabbing nerve pain in that toe, which is still completely numb in certain spots. Unfortunately, the nodule has grown back as well. I’m not sure if the injections caused the nerve damage or if the actual removal of the nodule did, but had I received general anesthesia, I would not have had to suffer through those excruciatingly painful injections.

Because of that horrible experience, I am now very reluctant to consider elective surgery again.

We, as chronic pain sufferers, must always advocate for ourselves. Or have someone advocate for us, if we are unable. We should question the decisions made by our medical providers if they don’t seem right or if we are unsure or nervous about a procedure. While there are many competent doctors and surgeons, unfortunately, there are some that are not and who don’t always have our best interest in mind.

I never could have predicted the horrible outcome of that surgery. But the lesson I’ve learned is to ask as many questions as possible prior to any procedure and to thoroughly research any physician who is going to cut into my body. One good question to ask is, “How many of these surgeries have you performed?” Newer surgeons can be perfectly capable, but the more experienced a surgeon is, the better the outcome will likely be for you.

RA can present many challenges, mainly severe pain, but it can also affect a patient’s mobility and morbidity. I will need to decide if I want to have another surgery to remove the recurrent toe nodule or decide if it is something I can learn to live with. Either way, I have learned some valuable lessons.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Lipofilling Improved Pain and Function in Patients with Finger Osteoarthritis

By Pat Anson, PNN Editor

People who suffer from painful arthritic fingers have few treatment options to choose from. They can wrap their hand in a splint, take anti-inflammatory drugs or get steroid injections into their finger joints – all of which provide only temporary relief. More invasive surgical treatments include joint fusions or reconstruction, which can impair hand motion and take weeks to recover from.

German researchers have found that a less invasive treatment commonly used in plastic surgery – injecting fat tissue from one part of the body into another -- can provide lasting improvements in pain and function for patients with finger osteoarthritis. The technique – called lipofilling – resulted in “highly significant clear improvement" with no complications in a small pilot study of 15 patients.     

"We believe that for our patients the reduction of pain represents the most striking and important result, which also has the most pronounced and highly significant effect," said co-author Max Meyer-Marcotty, MD, Clinic for Plastic, Reconstructive, and Aesthetic Surgery/Hand Surgery in Lüdenscheid, Germany.

"Even over a long-term follow-up, the transfer of fatty tissue to arthritic fingers joints appears to provide a safe and minimally invasive alternative to conventional surgery for patients with osteoarthritis.”

In the lipofilling procedure, Meyer-Marcotty and his colleagues used liposuction to take a small sample of each patient's fatty tissue from their upper thigh or hip area. The autologous fat was then injected into their arthritic finger joints. Patients wore a splint around the treated fingers and took pain relievers for a week. There were no infections or other complications reported.

The researchers followed outcomes in 25 finger joints for an average of 44 months after treatment, and found that pain scores fell from a median of 6 (on a 10-point scale) before treatment to just 0.5 points at follow-up. Grip strength of the treated fingers approximately doubled, while fist closure and hand function performing everyday tasks also improved.

“Even after a follow-up examination period of 44 months, the transfer of fatty tissue to arthritic finger joints has shown itself to be a minimally invasive, safe, and promising alternative to conventional surgical techniques aimed at alleviating arthritic complaints, and one that among other things entails a highly significant improvement in postsurgical pain levels,” researchers reported in the journal Plastic and Reconstructive Surgery. “Further long-term follow-up studies of even larger patient cohorts would be needed to further corroborate these initial positive findings.”

In recent years, lipofilling procedures have been increasingly used in plastic and reconstructive surgery, as well as stem cell therapy.

When injected into patients, mesenchymal stromal cells (MSCs) in fat tissue can regenerate damaged or diseased tissue, including cartilage in arthritic joints. A small 2019 study found that MSCs collected from a patient’s bone marrow can significantly reduce pain from knee osteoarthritis for up to a year.

Osteoarthritis is a progressive joint disorder caused by the inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

"The chance to preserve the joint with a minimally invasive procedure is of particular interest in the early, albeit painful, phases of finger osteoarthritis," said Meyer-Marcotty. "Since the lipofilling procedure is nondestructive, conventional joint surgery can still be performed later, if needed."

Sacroiliac Joints: An Overlooked Cause of Back Pain

By Victoria Reed, PNN Columnist

I’ve suffered from low back pain for a long time, beginning in my 20’s. I would have terrible spasms, pain, stiffness and leg numbness, which left me unable to walk or function at all.

I went through the usual testing to determine the cause and was asked if I had had some kind of accident or injury. The answer was always no. The only thing I could think of that may have contributed to the back pain was the fact that I ran track throughout my elementary and high school years. I figured all that running might have taken a toll on my spine.

An MRI revealed a bulging disk at the lumbar level. I was offered a nerve block, which helped relieve the pain for a while. But when I had children, the pain returned -- probably because the strain and added weight from pregnancy put extra pressure on my spine. 

A doctor offered a series of epidural spinal injections in which a steroid would be injected to try and shrink the bulging disk. The first shot didn’t work at all, but I was encouraged to try another one. The second didn’t work either. I was then put on pain and nerve medications, which did help somewhat.

Because I was using a prescription opioid, I had to go back periodically for regular exams to see if the meds were helping and still necessary. During one of those routine exams, the doctor asked me to point specifically to where the pain was coming from. I had been doing my own research online and thought the majority of the pain wasn’t coming from the bulging disk, but from my sacroiliac (SI) joints.

The SI joints are made up of the sacrum and the ilium of your pelvis, and are located on the right and left sides of your lower back. They are held in place by strong ligaments. Rheumatoid arthritis (RA) might increase the risk of having trouble with these joints. Though it’s commonly said that RA primarily affects the hands and feet, any joint can be affected.

I mentioned that to my doctor, but he wanted me to have more epidural steroid injections. I refused, partly because they didn’t help before and partly because I’m diabetic, and high-dose steroids cause the blood sugar to go up.

From there, I was sent to physical therapy. The therapy sessions were centered around strengthening my core abdominal muscles, and they did help reduce the number of times my back went out. However, the SI joint pain was still consistently there. During subsequent doctor appointments, and finally after some convincing, the doctor agreed that the SI joints were causing my pain.

SI joint pain is an often-overlooked cause of back pain, and can be confused with disk pain. It’s important to find any and all causes of persistent back pain because the treatments can be different.

Some years later, I agreed to try steroid injections into the SI joints, despite the effect I knew it would have on my blood sugar. Steroids can also make your body resistant to insulin.  I figured it was worth the risk if there was a chance at pain reduction. However, I knew that it would not be something that I could do regularly, and while not 100% helpful, there was some temporary modest relief. 

Since then, I’ve been able to identify what triggers the SI joint pain, and I use several different modalities for relief, including ice, low-dose oral steroids, stretches, and prescription pain medication.

How to Tell the Difference

Pain that is from a bulging or herniated disk can radiate down one leg and cause numbness or tingling. This pain is usually centered in the lower back, whereas pain from the SI joints can be pinpointed to one side or both. Pain from a bad disk can travel all the way down to the feet or toes, while SI joint pain usually stays above the knee.

Leg weakness can be very severe in a disk rupture, even to the point where you are dragging your foot. If you lose bowel or bladder control, that may be a sign of a serious condition called cauda equina syndrome and is considered a medical emergency!

Weakness in a leg from SI joint dysfunction usually isn’t prominent, but you can have numbness and tingling. SI joint pain can be triggered by going from a sitting to a standing position or by sleeping on one side. A trip or a stumble can also set off SI joint pain, and sitting for long periods of time can make either condition worse. Bending or twisting can aggravate a bulging or herniated disk.

While it’s always helpful to pay close attention to your symptoms, imaging is usually necessary. MRI is a valuable tool to get a good look at bulging or herniated disks. I would also keep a pain diary to make a note of what your pain triggers are and where the pain occurs. Make a note also of what relieves the pain (if anything).

All of these things can be helpful with assisting your doctor in making a proper diagnosis. Only until you get the correct diagnosis can you take steps to begin treatment and possibly achieve some lasting relief.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Low Fat Vegan Diet Reduces Rheumatoid Arthritis Pain

By Pat Anson, PNN Editor

A small new study found that a low-fat vegan diet can help improve joint pain in patients with rheumatoid arthritis – the latest research to show that healthier diets can significantly reduce pain levels. Study participants also lost weight and lowered their cholesterol levels by eliminating their consumption of animal fats and inflammatory foods.

Rheumatoid arthritis (RA) is a progressive and incurable disease in which the body’s immune system attacks joint tissues, causing pain, inflammation and bone erosion.

“A plant-based diet could be the prescription to alleviate joint pain for millions of people suffering from rheumatoid arthritis,” says lead author Neal Barnard, MD, president of the Committee for Responsible Medicine. “And all of the side effects, including weight loss and lower cholesterol, are only beneficial.”

Thirty-two people diagnosed with RA from the Washington DC area completed the study after being assigned to one of two groups for 16 weeks.

The first group followed a vegan diet for four weeks, eliminating their consumption of meat, dairy products and eggs. During weeks 5 through 7, the diet was further restricted to eliminate gluten-containing grains, as well as potatoes, chocolate, nuts, citrus, onions, tomatoes, bananas, apples and coffee.

Vegan foods that participants were encouraged to eat included rice, oats, quinoa, broccoli, kale, collards, Brussels sprouts, squash,  carrots, apricots, blueberries, plums, lentils and beans. There were no restrictions on calories or how often they ate.

After week 7, the excluded foods were reintroduced, one at a time, every 2 days. Any food that was associated with pain or other symptoms upon reintroduction was eliminated

The second group followed an unrestricted diet but were asked to take a daily placebo capsule.  After 16 weeks, the groups switched diets.

The study findings, published in the American Journal of Lifestyle Medicine, showed a significant reduction in pain and inflammation during the vegan stage of the study. Participants lost an average of two points in their Disease Activity Score-28 (DAS28), which measures swollen joints, joint tenderness and C-reactive protein levels – a marker for inflammation. DAS28 levels typically increase with rheumatoid arthritis severity.

The average number of swollen joints decreased from 7.0 to 3.3 in the vegan phase, while increasing slightly for participants in the placebo phase.

In addition to reductions in pain and swelling, participants lost an average of 14 pounds on the vegan diet, compared with a gain of about 2 pounds on the placebo diet. There were also greater reductions in total, LDL, and HDL cholesterol during the vegan phase.

Notably, although participants were asked not to alter or reduce their use of medication during the study, several of them did so – in most cases because they felt less need for them.

“In conclusion, the current study suggests that a low-fat vegan diet eliminating specific foods, without fasting and without caloric restriction, may improve joint pain. Additional studies are needed in which the diagnosis is confirmed by independent observers and medications remain stable in a larger sample,” said Barnard.

Many previous studies have shown an association between healthy diets and lower pain levels. Gluten-free diets have been shown to improve symptoms of fibromyalgia and neuropathy, while Mediterranean diets rich in anti-inflammatory foods lower the risk developing chronic pain. And diets that include lots of fatty fish and less processed food reduce the frequency and severity of migraines.

One of the strictest diets of all – a very low energy diet (VLED) that limits people to just 800 calories a day – was recently found to significantly reduce fibromyalgia pain after just three weeks.

FDA Approves Pain Reliever for Cats Considered Too Risky for Humans

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a new medication to treat osteoarthritis pain in cats, the first monoclonal antibody drug approved by the FDA for use in any animal. The same type of drug has been rejected for use in humans because of safety risks.

Solensia (frunevetmab) is an injectable monoclonal antibody made by Zoetis that targets nerve growth factor (NGF), a protein that increases in animals and humans due to injury, inflammation or pain. Solensia is designed to bind to NGF and inhibit pain signals from reaching the brain.

Osteoarthritis (OA) is a progressive joint disorder that leads to thinning of cartilage and joint damage.  Feline OA is a common condition in older cats, but treatment options for them are limited, as they are for humans.

“Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats. But with longer lives come chronic diseases, such as osteoarthritis," said Steven Solomon, DVM, director of the FDA's Center for Veterinary Medicine.

"Today's approval marks the first treatment option to help provide relief to cats that are suffering from this condition and may significantly improve their quality of life. We also hope that today's approval of the first monoclonal antibody by the FDA for any animal species will expand research and development of other monoclonal antibody products to treat animal diseases."

Safety Issues with NGF Inhibitors

Last year the FDA refused to approve tanezumab, a monoclonal antibody and NGF inhibitor, as a treatment for OA in humans after two of its advisory panels said the drug caused OA joint damage to accelerate. Rapidly progressing osteoarthritis (RPOA) was so severe that some patients in clinical trials had to stop taking the drug and needed total joint replacements.

The side effects of NGF inhibitors have been known for over a decade. The FDA slowed the development of NGF inhibitors in 2010 because of concerns they make osteoarthritis worse in some patients. But under pressure to approve more non-opioid pain relievers, the FDA allowed clinical studies of tanezumab to resume in 2015.

Eli Lilly and Pfizer invested heavily in tanezumab research, but ended their joint development of the drug in 2021 after the FDA and European Medicines Agency said they would not approve tanezumab for humans because of safety concerns.

In a press release announcing the approval of Solensia for cats, the FDA makes no mention of RPOA in its list of side effects, which includes vomiting, diarrhea, injection site pain, scabbing, dermatitis and itchy skin. The release said side effects were mild and did not require ending treatment during observational animal studies.  

In the FDA’s more detailed Freedom of Information Summary for Solensia, the agency said “RPOA has not been characterized or reported in cats,” but has this stark warning for humans who administer the drug:

“Women who are pregnant, may become pregnant, or are breastfeeding should take extreme caution to avoid accidental self-injection of Solensia. It is well-established that NGF is important in the normal development of the fetal nervous system, and laboratory studies in nonhuman primates have shown that human anti-NGF mAbs can cause reproductive and developmental toxicity. Fetal abnormalities, increased rate of stillbirths, and increased postpartum fetal mortality were noted in rodents and nonhuman primates receiving anti-NGF mAbs.”

Solensia is not recommended for pregnant or lactating cats. It will only be available by prescription from a licensed veterinarian who administers the injection monthly.

“The approval of Solensia is a significant step forward in the control of feline OA pain. Cat owners and veterinarians alike can feel confident that Solensia, with active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for felines, has been studied and demonstrated to control OA pain and help cats get back to moving more freely again,” Mike McFarland, DVM, Chief Medical Officer for Zoetis, said in a statement.

The use of Solensia in cats was approved by the European Medicines Agency last year. The drug is expected to be available to U.S. veterinarians in the second half of 2022.

Exercise Reduces Pain by Increasing Beneficial Bacteria

By Pat Anson, PNN Editor

Regular exercise can benefit people in many different ways, helping us lose weight, reduce the risk of heart disease, and boosting overall health.  

But researchers at the University of Nottingham have found that exercise has an unexpected benefit for people with arthritis. Regular exercise increases levels of beneficial bacteria in their digestive tracts, which reduces pain and inflammation by increasing levels of endocannabinoids – cannabis-like substances naturally produced by the body.

The study, published in the journal Gut Microbes, is believed to be the first to find a potential link between endocannabinoids, exercise and gut microbes.

"Our study clearly shows that exercise increases the body's own cannabis-type substances. Which can have a positive impact on many conditions,” says lead author Amrita Vijay, a Research Fellow at Nottingham’s School of Medicine. "As interest in cannabidiol oil and other supplements increases, it is important to know that simple lifestyle interventions like exercise can modulate endocannabinoids."

Vijay and her colleagues enrolled 78 people in their study. Half of the participants did 15 minutes of muscle strengthening exercises every day for six weeks, and the rest did nothing. Blood and fecal samples were collected from both groups.

At the end of the study, participants who exercised not only had lower pain levels, they also had significantly more Bifidobacteria and Coprococcus 3 -- bacteria that produce anti-inflammatory substances and lower levels of cytokines, which regulate inflammation.

These gut bacteria were particularly adept at raising levels of short chain fatty acids (SCFAs), which increase levels of endocannabinoids. About a third of the anti-inflammatory effects of the gut microbes was due to their ability to raise endocannabinoid levels.

Importantly, the exercise group also had lower levels of Collinsella – a bacteria known to increase inflammation that is strongly associated with processed food and diets low in vegetables.    

“In this study we show that circulating levels of ECs (endocannabinoids) are consistently associated with higher levels of SCFAs, with higher microbiome diversity and with lower levels of the pro-inflammatory genus Collinsella. We also show statistically that the anti-inflammatory effects of SCFAs are up to one third mediated by the EC system,” researchers concluded.

Previous studies have also found an association between gut bacteria and painful conditions. A 2019 study at McGill University found that women with fibromyalgia had 19 different species of bacteria that were present in either greater or lesser quantities than a healthy control group.

Bacteria associated with irritable bowel syndrome, chronic fatigue syndrome and interstitial cystitis were also found to be abundant in the fibromyalgia patients, but not in the control group.    

Having a healthy diet can also affect pain levels for migraine, neuropathy and other types of chronic pain. A recent study funded by the National Institutes of Health found that migraine sufferers who ate more fatty fish and reduced their consumption of polyunsaturated vegetable oils — frequently found in processed foods — had fewer headaches.

FDA Approves First ‘Interchangeable’ Biosimilar for Humira

By Pat Anson, PNN Editor

People living with rheumatoid arthritis, psoriasis and other arthritic conditions will finally have a cheaper alternative to an expensive biologic drug — but they’ll have to wait a couple of years before its available.

The Food and Drug Administration has approved Cyltezo (adalimumab-adbm) as the first “interchangeable” biosimilar product to treat chronic inflammatory diseases, making it eligible to be substituted for Humira (adalimumab). Cyltezo won’t be on the U.S. market until 2023.

An interchangeable biosimilar may be substituted without the prescriber having to change the prescription. The substitution may occur at the pharmacy, similar to how cheaper generic drugs are often substituted for brand name drugs by insurers.

Biologic drugs are derived from living organisms such as animal cells or bacteria, and are expensive to manufacture. Biosimilars are “highly similar” to biological products, clinically just as effective, and cheaper to make.

The cost savings will probably be significant for switching from Humira to Cyltezo. Humira is an injectable drug that costs $7,389 for a one-month supply, or about $88,000 a year.

Cyltezo is also injected and citrate-free, which results in less pain on injection. Cyltezo is expected to cost about 30% less than Humira.

"As the first interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products," Martin Alan Menter, MD, chair of the Division of Dermatology at Baylor University Medical Center, said in a statement on behalf of Boehringer Ingelheim, Cyltezo’s manufacturer.

"This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo has the same efficacy and safety as the originator medicine with the added benefit of cost savings."

Although Cyltezo was first approved by the FDA in 2017, its commercial launch was delayed by legal actions taken by AbbVie, Humira’s manufacturer. Humira is Abbvie’s top selling drug, and generated revenues of $4.8 billion in the first quarter of 2021.

Boehringer Ingelheim reached a settlement with AbbVie in 2019, agreeing to pay AbbVie royalties and delaying Cyltezo’s release until July 1, 2023.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market due patent disputes and legal maneuvers.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said acting FDA Commissioner Janet Woodcock, MD, said in a statement. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”   

Cyltezo is approved for the following conditions in adult patients:

• Moderate to severe rheumatoid arthritis

• Psoriatic arthritis

• Ankylosing spondylitis

• Crohn’s disease

• Moderate to severe ulcerative colitis

• Moderate to severe chronic plaque psoriasis.

Cyltezo is also approved for moderate to severe active polyarticular juvenile idiopathic arthritis in children two years of age and older, and in pediatric patients six years of age or older with Crohn’s disease. 

"We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira. It is a true milestone and an important step forward for broader adoption in the U.S. and for patient access to affordable medicines," Thomas Seck, senior vice president at Boehringer Ingelheim, said in a statement.

One in Four U.S. Adults Have Arthritis

By Pat Anson, PNN Editor

Nearly one in four American adults --- 58.5 million people – report having arthritis, according to a new study by the CDC that highlights both the aging of the U.S. population and the challenges that poses for the nation’s healthcare system.

Arthritis is a disease that causes joint pain and stiffness, which typically worsen with age, and is the leading cause of adult disability. The most common types of arthritis are osteoarthritis and rheumatoid arthritis.

Researchers found that over half of Americans aged 65 and older have arthritis (50.4%); along with adults who are disabled or unable to work (52.3%); and adults who rate their health as either fair or poor (51.2%).

The national prevalence of disability linked to arthritis – what the CDC calls arthritis-attributable activity limitations (AAAL) – has been steadily rising for nearly two decades. The trend appears to be accelerating due to aging, rising levels of obesity and reduced physical activity. The CDC estimates nearly 26 million Americans had AAAL in 2016-2018.

SOURCE: CDC

"AAAL prevalence continues to increase more rapidly than was projected. Because population aging and other contributing factors (e.g., obesity) are expected to sustain these trends, public health, medical, and senior and other service systems face substantial challenges in addressing the needs of adults with arthritis, who already account for nearly one quarter of U.S. adults," researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

To address the social, physical and economic challenges of arthritis, the report recommends an expansion of outreach programs to individuals and groups at high risk of arthritis. AAAL is common among adult American Indian or Alaskan Natives (60.7%); low income adults (53.3%); adults living near or below poverty levels (63.3%); disabled adults (82.6%); and those with serious psychological distress (76.3%).

“Existing self-management education and physical activity public health interventions that are arthritis-appropriate and inclusive of adults with disabilities have proven benefits, including improved aerobic activity, confidence, and self-rated health and reduced depression, fatigue, and pain. These positive effects might be bolstered by combination with medical management, particularly for joint symptoms and mental health,” researchers said.

One step arthritis sufferers can take to help themselves is to make greater use of the Americans with Disabilities Act (ADA), which is underused by people with rheumatic conditions. The ADA can help eliminate physical barriers and improve access to transportation, building access, and workplace accommodations. If you feel you've been discriminated against because of a disability, you can file a complaint with the U.S. Justice Department under the ADA.

The Job Accommodation Network is another free resource that can be used for confidential job counseling, employment advice, facilitation of workplace accommodations, and the resolution of disability-related employment issues.

Surprise Discovery Could Lead to Vaccine for Rheumatoid Arthritis

By Pat Anson, Editor

A surprise discovery at a university laboratory could lead to a vaccine that can prevent rheumatoid arthritis, a chronic and incurable disease in which the body’s own immune system attacks joint tissues.

Researchers at The University of Toledo years were studying a protein called 14-3-3 zeta and its role in immune system pathologies. Previous studies have suggested the protein could be a possible trigger for rheumatoid arthritis (RA) and other autoimmune conditions that cause pain, inflammation and bone erosion.

But researchers found just the opposite. The team discovered that 14-3-3 zeta proteins may actually help prevent arthritis. When they removed the proteins through gene-editing technology, it caused severe early onset arthritis in laboratory animals.

Realizing that the proteins may be beneficial, the team developed an experimental vaccine using purified 14-3-3 zeta protein grown in a bacterial cell. They found the vaccine promoted a strong, immediate and long-lasting response in rodents that protected them from RA.

"Much to our happy surprise, the rheumatoid arthritis totally disappeared in animals that received a vaccine," said Ritu Chakravarti, PhD, an assistant professor at UToledo College of Medicine and lead author of research published in the journal Proceedings of the National Academy of Sciences. "Sometimes there is no better way than serendipity. We happened to hit a wrong result, but it turned out to be the best result. Those kinds of scientific discoveries are very important in this field."

In addition to suppressing the immune system response, the vaccine also significantly improved collagen content and bone quality — findings that suggests there could be long-term benefits following immunization.

Currently, rheumatoid arthritis is treated with steroids or medications that suppress the immune system, such as biologics and biosimilar drugs. While those therapies can alleviate pain and reduce inflammation, they can also make patients more vulnerable to infection and, in the case of biologics, are expensive. Biologic drugs can cost $25,000 a year.

“We have not made any really big discoveries toward treating or preventing rheumatoid arthritis in many years,” Chakravarti said. “Our approach is completely different. This is a vaccine-based strategy based on a novel target that we hope can treat or prevent rheumatoid arthritis. The potential here is huge.”

RA affects about 1.5 million Americans and about one percent of the global population. Women experience RA at a rate three times greater than men, have more severe symptoms and increased disability.

“In spite of its high prevalence, there is no cure and we don’t entirely know what brings it on. This is true of nearly all autoimmune diseases, which makes treating or preventing them so difficult,” said Chakravarti. “If we can successfully get this vaccine into the clinic, it would be revolutionary.”

Chakravarti and her colleagues have filed for a patent on their discovery and are seeking pharmaceutical industry partners to fund more research and preclinical trials.

Rare Disease Spotlight: Sarcoidosis

By Barby Ingle, PNN Columnist

This month’s rare disease spotlight is on sarcoidosis. I have many friends living with this complex, autoimmune disorder, which affects about 200,000 Americans.

One of the first visible signs of sarcoidosis is for red bumps and patches called granulomas to form on the skin. Granulomas can also develop in the lungs, lymph glands and other internal organs, causing shortness of breath, abnormal heart rhythm, swollen glands and painful joints. The symptoms often appear suddenly and vary from person to person, depending on which organs are affected.

Although the symptoms usually go away on their own after a few months, the patients I know have lived with sarcoidosis long term. Some are less affected than others, but most people living with chronic sarcoidosis have major changes in every aspect of their body and life activities.

I think it is best to spotlight some of the people in my life who live with sarcoidosis on a daily basis. Frank Rivera and Kerry Wong have a website called Stronger Than Sarcoidosis. Karen Duffy shared her journey with sarcoidosis in one of my favorite books, "Backbone: Living with Chronic Pain without Turning into One."

You’ll see by reading their responses that sarcoidosis is tough to have, but they are tough, too.

How long have you lived with sarcoidosis?

Wong: “I was diagnosed in 2015, but that was after an 8-year search for answers … so I would say probably closer to 14 years.”

Duffy: “I have been living with sarcoidosis for 23 years! It took about 2 years to get a diagnosis of exclusion.”

Rivera: “I have been living with sarcoidosis since 2004, 17 years, but fully diagnosed in 2011. So, 10 years since diagnosis.”  

In what ways has living with sarcoidosis affected your life?

Duffy: “Sarcoidosis has impacted my life in countless ways. I live with neuro-sarcoidosis and I have severe pain issues. I also have Complex Regional Pain Syndrome. I find that the principles of stoic philosophy have really helped me accept that I cannot control what happens, I can only control how I respond.”

Rivera: “I am on disability now due to the bone and joint involvement and the pain I live with is a 6-7 pain level on a pain scale of 1-10, daily.”

Wong: “Oh, so many ways! Because the symptoms can be both severe and so unpredictable, I’m no longer able to work, and have been on disability since 2014. I’ve had to cancel plans with friends and family more times than I can count. And I’ve had to depend on my husband for so much more, for even the little things. But I’m so grateful for how he has stepped up as an incredible caregiver.

And that’s not to mention the emotional toll of the physical manifestations, the anxiety and depression that come from living with chronic pain, fatigue, and disability.”

Have you found anything that was helpful for the symptoms of sarcoidosis?

Duffy: “I believe in the power of the placebo. In Latin, placebo means "I Shall Please." I try to be useful, so I keep up with my volunteer projects. I find reading to help when I am roped to my sofa like Gulliver. On days when I am released from the grip of chronic pain, I love to walk. I follow my doctors’ advice and take my prescription meds.

I have found a pain cream called Tribe Revive---and it works for me! I no longer wear a pain patch, I just rub this CBD infused cream and the relief is instant. I have no connection to the company that makes the pain cream, I am just a very grateful customer. I buy so much of it and give out jars.”

Rivera: “Prednisone helped some, but the side effects almost killed me. Gave me a hole in my colon and diabetes as well as brittle bones.”

Wong: “Yes, thank goodness! Even after all this time, we are still working on finding the right treatment combination to help with my symptoms, but there are a few things that have helped. IVIG (Intravenous Immunoglobulin) therapy; heat and cold therapy; TENS (transcutaneous electric nerve stimulation); eTNS (electric trigeminal nerve stimulator); acupuncture and acupressure; and medical marijuana in a variety of forms.

Aside from that, probably the most helpful thing is learning to listen to my body. When it says I have to rest, I have to rest. Pushing myself to do more, which is what I have always done before, will only make me suffer that much more and that much longer afterward.”

Do you think there is a societal stigma on people living with sarcoidosis and other rare diseases?

Duffy: “I find that living with a chronic, invisible illness has its challenges. The pain from the nerve damage is cataclysmic, and it can be confusing that some days I can walk my dog, go for walks, and socialize with friends. Then other days, I am wiped out and live a smaller, quieter life. On these days, I read and write.”

Wong: “I am not sure if stigma is the word I would use, but there is definitely an additional problem for us. Because most people have never heard of sarcoidosis, they find it hard to understand and try to compare it to things they know. How often do we hear, ‘At least it’s not cancer?’  And because most of our symptoms are invisible, they find it hard to believe what they don’t see. That lack of understanding can have a tremendous impact on both personal and professional relationships.”

Rivera: “Yes, because from the outside we look fine. It is called an invisible illness because it works from the inside out.”

Is there anything you wish the world knew about sarcoidosis?

Wong: “Honestly, the thing I would love for people to understand most is how unpredictable the disease can be. Our symptoms can vary from day to day or hour to hour. That means what we are able to do varies as well. We always see inspirational examples of people who ‘didn’t let xyz stop them,’ but that is just not how it works with an incurable rare disease.

I always strive to do as much as I can to help others, but some days, the symptoms do win. That is not a character flaw or weakness; it is just the fact of the disease. Once those symptoms ease up and I am able to do more, I will always bounce back with purpose.”

Duffy: “I know it can be overwhelming to live with a rare, complicated, multisystem disorder. I have a serious illness, but I do not take it too seriously. Having a painful diagnosis and having a great life is possible. I am grateful for every day.”

Rivera: “Sarcoidosis is when a person's white blood cells become over active from an environmental accelerant. And instead of fighting off colds or foreign substance in the body, they clump together and form masses anywhere in the body as well as skin. This disease is a very painful disease and attacks the physical and mental health of a person.

With sarcoidosis, no two patients are alike. They call it the snowflake disease because no two patients are the same. That makes it very difficult to diagnose as well as treat because each temporary medicine does not work the same for each patient as well. So trying to help a sarcoidosis patient is very tough.”

Getting Help

If you need help with sarcoidosis, you should set up appointments with specialists to add to your treating team. These professionals would include a primary care provider, rheumatologist, pulmonologist, ophthalmologist and dermatologist.

Steroids are usually used to treat sarcoidosis. They reduce inflammation, and can stimulate tissue growth and repair. If steroids don’t work, immunosuppressant medications might be tried to reduce the immune system response. Pain medications may also be prescribed.  

Although the cause of sarcoidosis is unknown, the most widely known theory is it may be due to an immune reaction to a trigger, such as an infection or chemicals in those who are genetically predisposed. I look forward to the day that better testing and treatments exist for this rare disease.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.

Biosimilar Drugs Are Cheaper Than Biologics, But Are They as Effective?

By Michelle Andrews, Kaiser Health News  

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

ELLE MOXLEY

Yet the U.S. has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges:

“Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

‘Highly Similar’ Drugs

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Dr. Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Dr. Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs. However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Another Drug Shortage Caused by Covid-19 Has Me Worried

By Victoria Reed, PNN Columnist

I recently read a news article about the Food and Drug Administration issuing an emergency use authorization for Actemra (tocilizumab) for the treatment of hospitalized covid-19 patients. The medication was originally developed as a treatment for rheumatoid arthritis (RA), one of the chronic pain conditions I live with.  

Actemra is a biologic drug that calms down overactive immune systems by blocking the interleukin-6 (IL-6) receptor. Persistent dysregulated expression of the IL-6 receptor is involved in the pathogenesis of RA and other chronic inflammatory and autoimmune diseases. It is believed that this over-activation of the IL-6 receptor is also responsible for the so-called “cytokine storm” that causes severe illness and death in covid-19 patients.

The symptoms of RA are pain, fatigue and swelling in the lining of the joints and other parts of the body, including the heart, lungs and eyes. This inflammation can lead to disability, joint destruction and cause serious damage to the lungs and heart.

I have had long-term success controlling my RA symptoms with Actemra and have been getting the drug by IV infusion monthly for about 8 years. Prior to that, I didn’t have good control with other biologic meds such as Enbrel and Orencia.

When I read that news story, I was initially only mildly concerned about Actemra becoming unavailable. Nevertheless, I contacted my doctor for confirmation that I was still on track for my upcoming monthly infusion. However, she did not and could not confirm that the medication would be available to me. Why?

Actemra has now been hijacked by doctors treating covid-19 patients, and this has created a major shortage. I have been informed that its availability for RA patients is uncertain for the foreseeable future. This is really very upsetting!

Covid-19 patients are using up resources in hospitals across the country. The overwhelming needs of these severely ill patients are causing other patients who need surgery or have treatable illnesses to die from a lack of available resources. Hospitals in hard-hit areas are short on everything -- staff, meds, beds and time. As a result, many chronic pain patients like me are being denied the treatments that we rely on to have functional lives. I must say that this seems patently unfair.

What’s even more disconcerting is that Genentech, Actemra’s manufacturer, can’t say when the shortage will end and expects “additional intermittent periods of stockouts (lack of supply) in the months ahead, especially if the pandemic continues at the current pace.”

RA and lupus patients saw this happen earlier in the pandemic when word got out that Plaquenil (hydroxychloroquine) might help treat covid-19. That medication also became scarce and was inaccessible to patients with autoimmune conditions for a while.  

One thing for sure is we are all very tired of the covid virus and its variants. I understand that doctors and scientists are desperate to find things that work, and they want to save lives. But I rely on Actemra to help relieve my pain and fatigue and keep damaging inflammation down. It is the mainstay of my treatment.  

Due to the Actemra shortage, I may have to consider other medications that might not work as well or just wait out the shortage and hope my disease activity doesn’t become unbearable.  

If the pandemic continues, many more people are going to lose their lives from covid infections. However, all patients deserve an equal chance at receiving the care they need, including chronic pain patients. The pain community is already suffering from opioid hysteria and many of us have to fight to stay on these pain medications. We shouldn’t have to fight for our other meds too! 

RA is a serious, systemic and often misunderstood condition that can shorten a lifespan by many years if not treated aggressively and with the proper medications.  Patients sometimes go through many trials of medications before finding one that relieves symptoms and arrests disease activity.  

I truly hope this shortage is short-lived -- for myself and others like me -- who rely on Actemra to remain functional and productive.  

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis.

Experimental Implant Repairs Joints With Cartilage Made From Stem Cells

By Pat Anson, PNN Editor

An experimental implant containing cartilage derived from stem cells reduced pain and restored function in dogs with damaged hip joints -- a study that researchers say could be a significant step towards repairing and replacing cartilage in humans with osteoarthritis.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

“One of the holy grails of orthopedics is to replace cartilage, but there hasn’t been an effective way to do it,” says co-author Duncan Lascelles, PhD, a professor of surgery and translational pain research and management at North Carolina State. “Most of the focus is on replacing or restoring the cartilage surface with artificial materials, but regenerating cartilage isn’t possible right now. And many of the artificial products in use don’t integrate with the body.”

Lascelles and his colleagues developed a cartilage repair implant using a textile manufacturing process that utilizes three-dimensional (3D) weaving with composite material. When seeded with a patient’s own stem cells, the “bioartificial” implant is designed to integrate with native bone while preserving the integrity of the joint.

“Combining 3D printing with advanced textiles enabled us to engineer an implant that mimics the function of native, healthy tissues in the joint from day one after implantation,” said co-author Bradley Estes, PhD, President of Cytex Therapeutics, which developed the implant technology. “We also designed it to dissolve over time so that, ultimately, joint function is transferred back to the patient’s own tissues during the healing process.”

The researchers used the implant to resurface damaged hip joints in dogs. Cartilage derived from stem cells was first allowed to grow on the implant for several weeks before surgery, then the implant was placed into the damaged area of the dogs’ joints. Over time, the implant dissolved, leaving only the dog’s own natural tissue in the repaired hip joint.

Four months after surgery, researchers say dogs that received the cartilage implant returned to baseline levels for both pain and function, while dogs in a control group never improved. They also saw evidence that the implant had successfully integrated into the hip joints, effectively resurfacing them.

“We were thrilled that the implant was so effective at restoring the activity levels of the animals,” Estes says. “After all, this is why patients go see their physicians – they want to be able to play tennis, play with their kids, and, in general, re-engage in a pain-free active lifestyle that had been taken away by arthritis.”

While osteoarthritis primarily affects older adults, researchers hope the experimental implant will address some of the problems associated with total joint replacements in younger, active patients.

“There are significant drawbacks to total joint replacements in the young patient,” Lascelles says. “The surgery is more complicated, and the artificial joints are only good for a particular number of years until they must be replaced, often with poorer results each time.

“This procedure is less invasive, and the implant uses the body’s own cells and integrates into the damaged area with little danger of rejection. We believe that it is an early intervention that could be a major advance in postponing joint replacements for dogs and hopefully one day for humans.”

The research findings are published online in Science Advances. The study was funded by Shriners Hospitals for Children, the Arthritis Foundation, the Nancy Taylor Foundation for Chronic Diseases, and the National Institutes of Health.