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.

Blood Pressure Meds May Help Treat Osteoarthritis

By Pat Anson, PNN Editor

People who suffer from osteoarthritis have few pain-relieving options outside of surgery and joint replacement. Opioids are usually not prescribed for osteoarthritis (OA) and over-the-counter drugs such as acetaminophen provide only mild relief or may have side effects if taken too often.

Some OA patients may have another treatment option already sitting in their medicine cabinets: blood pressure medication.

In a retrospective study, researchers at the University of Nottingham analyzed health data for over 223,000 people in the UK and found that patients taking two beta-blockers commonly prescribed for high blood pressure -- propranolol and atenolol -- made fewer trips to the doctor to be treated for knee and hip pain compared to those who don’t use the drugs. When patients stopped taking propranolol and atenolol, they had more office visits for joint pain.

The findings, recently published in the journal Rheumatology, suggest that beta-blockers have analgesic properties and may even slow the progression of osteoarthritis, a joint disorder that leads to thinning of cartilage in the knees, hips, fingers and spine. About 10% of men and 18% of women over age 60 have some form of osteoarthritis. .  

"Our findings suggest that atenolol could be considered for people with osteoarthritis and comorbidities for which beta blockers are indicated," co-authors Georgina Nakafero, PhD, and Abhishek Abhishek, PhD, said in a news release. "Similarly, propranolol may be a suitable analgesic for people with OA and comorbid anxiety.

"If these findings are confirmed in independent studies, and in a confirmatory randomized controlled trial, it may change clinical practice."

Previous research has suggested that beta-blockers have antinociceptive effects that help block pain signals. A 2017 study found the drugs lowered pain scores and reduced opioid use in 873 patients with OA. But a larger study failed to confirm those findings.

Two FDA advisory committees recently voted against recommending tanezumab, an experimental non-opioid pain reliever, as a treatment for osteoarthritis due to possible side effects. The agency has yet to make a final decision on the drug. If approved, tanezumab would be the first new class of medication for osteoarthritis in well over a decade.

Positive Results From Stem Cell Trial for Knee Osteoarthritis

By Pat Anson, PNN Editor

A California stem cell company has announced positive results from a small, early-stage clinical trial of an experimental stem cell therapy for knee osteoarthritis.  

The Phase 1/2a trial conducted by Personalized Stem Cells (PSC) involved 39 patients with knee osteoarthritis who were given a single injection of autologous mesenchymal stem cells derived from their own body fat. Safety was the primary objective of the trial and there were no serious adverse events reported by the company.

The secondary objective of the trial was to assess the effectiveness of the therapy with the Knee Injury and Osteoarthritis Outcome Score (KOOS), a survey that asks patients about their pain, other symptoms, daily function, quality of life, and recreational activities. Nearly 80% of study participants improved above the “minimal important change” (MIC), with an average improvement over baseline of 2.2 times the MIC.

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.

Results from the PSC study have been submitted to the FDA for review. The company hopes to get approval for a larger, Phase 2 randomized study of its stem cell therapy later this year.  

“We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis,” said PSC founder and CEO, Dr. Bob Harman. “We are proud to have reached this milestone in our first FDA approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.”

Veterinarians Already Using Stem Cells

While the FDA has approved hundreds of clinical trials of stem cells, it has not approved a single stem cell product as a treatment for arthritis or any orthopedic condition. That hasn’t stopped stem cell clinics from offering regenerative medicine to patients or veterinarians from using it on animals.

VetStem Biopharma, the parent company of PSC, pioneered the use of adipose derived stem cells in veterinary medicine. Its laboratory has processed stem cells for nearly 14,000 dogs, cats, horses and other animals for use by veterinarians in the U.S. and Canada.

“The 15 years of veterinary experience with adipose derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct,” said Harman.

In addition to the Phase 2 trial for osteoarthritis, PSC plans to pursue FDA approval for a stem cell trial to treat traumatic brain injuries in humans. A clinical study using PSC’s stem cell platform to treat respiratory distress syndrome in COVID-19 patients is currently underway.

FDA Panels Say New Arthritis Drug Too Risky

By Pat Anson, PNN Editor

Two FDA advisory committees have voted against recommending an experimental non-opioid pain reliever as a new treatment for osteoarthritis, dealing a potential death blow to a drug that’s been under development for 15 years.

On a nearly unanimous 19 to 1 vote, the FDA’s Arthritis Advisory Commitee and Drug Safety and Risk Management Advisory Committee decided that the benefits of tanezumab do not outweigh its possible safety risks, which include the acceleration of osteoarthritis in some patients.  Advisory committee recommendations are not binding on the FDA, but they are likely to carry a good deal of weight when the agency makes a final decision on tanezumab.

Pfizer and Eli Lilly are jointly developing tanezumab, an injectable humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body due to injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

FDA reviewers released a report this week saying tanezumab works as a pain reliever, but the effect “is modest, and there is no convincing evidence of a superior efficacy” over non-steroidal anti-inflammatory drugs (NSAIDs), the current standard treatment for osteoarthritis.

More concerning are the potential side effects of tanezumab, the most serious being rapidly progressing osteoarthritis that is so severe some patients need total joint replacements. Investigators say tanezumab also appears to affect healthy joints and causes “abnormal peripheral sensation” similar to carpal tunnel syndrome.

The side effects of tanezumab have been known for over a decade. The FDA slowed the development of tanezumab and other NGF inhibitors in 2010 because of concerns they make osteoarthritis worse in some patients.

Under pressure to approve more non-opioid pain relievers, the FDA allowed clinical studies of tanezumab to resume in 2015 and two years later gave it “fast track” designation to help speed its development.

Pfizer and Eli Lilly have conducted dozens of clinical trials evaluating the safety and efficacy of tanezumab on more than 18,000 patients. The companies at one time considered, but then abandoned plans to develop tanezumab as a treatment for chronic low back pain after 10% of patients given high doses developed joint pain and other side effects.

Critics say its time to finally throw in the towel on tanezumab.

“The drug is unsafe. It accelerates the underlying joint disease. And according to the FDA, even if you stop the drug early on, there’s evidence you can still progress to having these joint problems,” Michael Carome, director of Public Citizen’s Health Research Group, told PNN.  “The decision here is clear cut. The drug should not be approved. And in our view, no further studies on this drug should be done. Because it would be unethical to continue to expose people to this drug where the harm is clear and there’s no real benefit.”

A Pfizer spokesman said the company would continue to seek approval for tanezumab, despite the committees’ recommendation.

“While we are disappointed in today’s outcome, we continue to believe that the clinical data presented for tanezumab supports its benefit-risk profile,” Jim Rusnak, chief development officer for Pfizer, said in a statement. “The patients whom we aim to help with tanezumab are suffering from significant, debilitating osteoarthritis pain and have exhausted available medical therapies and are hopeful for new, non-opioid treatments. We will continue to work with the FDA to determine next steps.”

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. The World Health Organization estimates that about 10% of men and 18% of women over age 60 have some form of osteoarthritis.

Injections of Tiny Particles Reduce Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

A minimally invasive procedure significantly reduces pain and inflammation caused by knee osteoarthritis, according to preliminary research being presented this week at the annual meeting of the Society of Interventional Radiology.

Geniculate artery embolization (GAE) is a relatively new procedure in which thousands of microscopic particles are injected into arthritic knees. The particles reduce inflammation by disrupting the abnormal flow of blood caused by osteoarthritis (OA), a joint disorder that causes thinning of cartilage and progressive joint damage. As the cartilage breaks down, it releases enzymes that cause inflammation and pain.

GAE takes about one to two hours, and many patients with knee OA report significant improvement in pain and physical function that can last up to a year.

"Prior to treatment, patients' knee pain had taken over their whole life," said lead researcher Siddharth Padia, MD, a professor of radiology at UCLA Health. "But after treatment, patients who initially could walk only three or four blocks were walking three miles. Some were able to do away with walking aids, such as canes, while others reported being in a better mood now that they were living without pain."

For their Phase 2 study, Padia and his colleagues enrolled 40 patients with knee OA who were not candidates for total knee replacement, and who failed to benefit from pain relievers, joint injections and physical therapy.

Catheters were inserted into arteries leading to the knees through pinhole incisions in the patients’ hips. The microscopic particles — called Embozene microspheres — were then slowly injected through the catheter into the knees. Each patient was evaluated for pain and adverse events at one week; one, three and six months; and one year after the treatment.

Researchers say patients saw benefits as soon as three days after the procedure. Average pain levels decreased from 8 out of 10 before GAE to 3 out of 10 within the first week. Most patients reported more than 50% reduction in their pain levels at the one-year follow up.

Adverse events, such as skin ulceration and small bone infarction – the death of bone tissue due to reduced blood supply -- were reported by 9 patients, but resolved without treatment.

Embozene microspheres are made by Boston Scientific and are currently used in the treatment of vascular tumors, uterine fibroids and arterial malformations. They must be carefully injected into affected tissue to prevent them from circulating in the blood and reaching healthy tissue and organs.

“This prospective trial demonstrates that GAE is highly effective and durable in reducing symptoms due to moderate to severe knee OA that is refractory to other conservative therapy, and has an acceptably low toxicity profile,” researchers concluded.

The UCLA researchers plan to conduct a larger, randomized trial to determine which patients may benefit most from GAE and the impact it has on slowing the progression of arthritis.

Results from other studies on the use of GAE are also being presented at the meeting of the Society of Interventional Radiology. One review found that GAE can be effective for patients who don't respond well to conservative treatments for knee OA, but cautioned that “definitive conclusions can't be made on the true efficacy of GAE until studies are done with longer follow up and larger patient numbers.”

Latina and Asian Women at Significantly Higher Risk from Lupus

By Pat Anson, PNN Editor

Asians and Latinos diagnosed with systemic lupus erythematosus (SLE) are significantly more likely to die from the disease than other racial groups, according to a new analysis by the Centers for Disease Control and Prevention. The CDC set up half dozen state registries over a decade ago to help track the illness.

SLE is the most common form of lupus, a condition in which the body's immune system attacks its own healthy tissues, especially joints and skin, causing flare-ups of pain and fatigue that keep nearly half of adult patients from working.

In an effort to better understand why the disease disproportionately affects women and people of color, CDC researchers analyzed a database of over 800 SLE patients in San Francisco from 2007 to 2017. About 90 percent of them were female. Mortality rates were highest in racial and ethnic minorities who died during the study period,

“Asian females with SLE were four times more likely to die than were Asian females without SLE in the general San Francisco County population, and Hispanic/Latina females with SLE were six times more likely to die than were persons in the corresponding general populations,” researchers reported. “Higher mortality within these populations might be the result of more severe outcomes and manifestations of SLE, as previously demonstrated, or possibly less access to care.”

The mean age at death for people with SLE was 62 years. On average, Black persons died 6.8 years earlier than White people with SLE, while people of Hispanic/Latino ethnicity died 9.5 years earlier.

A recent study published in the journal Arthritis and Rheumatology estimated that over 200,000 Americans suffer from SLE, a number that comes statistically close to officially reclassifying the illness as a rare disease. The Rare Diseases Act of 2002 classifies conditions as rare when they affect 200,000 or fewer Americans. Until now, SLE disease estimates were larger but unverified.

“Our study potentially redefines systemic lupus erythematosus as a rare disease in the United States and lays the groundwork for where we need to focus our efforts to reduce the burden of this disease on Americans,” said lead investigator and rheumatologist Peter Izmirly, MD, an associate professor in the Department of Medicine at NYU Langone Health.

Rare-disease classification could, according to Izmirly, significantly improve efforts to study and treat SLE by reducing the number of participants needed for clinical trials.

Current treatments for lupus include steroids or other anti-inflammatory and immunosuppressing medications, including newer biologic drugs made from living cells.

Antidepressants Ineffective for Back Pain and Osteoarthritis

By Pat Anson, PNN Editor

Antidepressants like duloxetine (Cymbalta) are increasingly being prescribed to treat various types of pain, but a new study shows the medications are largely ineffective for people suffering from chronic back pain or osteoarthritis and may even cause harm.

Many clinical guidelines recommend using antidepressants as pain relievers – even when depression is not involved -- yet evidence supporting that use is uncertain. To address that knowledge gap, researchers at the University of Sydney reviewed data from 33 controlled trials involving more than 5,000 adults who took antidepressants for low back or neck pain, sciatica, or hip or knee osteoarthritis.

Their findings, published in The BMJ, show that for people with back pain the effects of antidepressants were too small to be worthwhile, but for those with osteoarthritis there may be a small beneficial effect.

“The use of antidepressants to treat people with chronic back pain and osteoarthritis is increasing worldwide, but prior to our work, it was not clear whether antidepressants relieved pain or were safe,” said lead author Dr. Giovanni Ferreira, PhD, a postdoctoral research fellow at the Institute for Musculoskeletal Health at the University of Sydney. 

“We conducted a review of all randomised clinical trials evaluating the efficacy of antidepressants for people with back pain or knee osteoarthritis and found that for back pain the antidepressants were either ineffective or provided a very small effect, which was unlikely to be perceived as worthwhile by most patients. For people with osteoarthritis, effects were still small, but could be potentially perceived as worthwhile by some patients” 

Ferreira and his colleagues reviewed six classes of antidepressants: serotonin-noradrenaline reuptake inhibitors (SNRIs); selective serotonin reuptake inhibitors (SSRIs); noradrenaline-dopamine reuptake inhibitors (NDRIs); tricyclic antidepressants; and tetracyclic antidepressants. 

Results showed that SNRIs such as duloxetine reduced back pain after three months, but the benefits were so small they were unlikely to be considered clinically important to most patients. SNRIs had a slightly stronger effect on sciatica and osteoarthritis pain. 

Tricyclic antidepressants were ineffective for back pain, but might reduce pain in people with sciatica, although the evidence for that was weak.  

Industry Funded Studies 

Importantly, about two-thirds of people taking SNRI antidepressants experienced an adverse event such as nausea, fatigue, mood swings and weight gain.

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm,” said Ferreira, adding that doctors need to be upfront with patients about possible side effects.

Researchers say the long-term effects of antidepressants prescribed for chronic pain are not well known and many of the studies that do exist were sponsored by industry, raising the risk of bias. 

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm.”

— Dr. Giovanni Ferreira

“Large, definitive trials free of industry ties are urgently needed to evaluate the efficacy of antidepressants,” Ferreira said. “There needs to be more transparency about how evidence coming from those trials is appraised by guideline panels. A good starting point would be to consider all industry-funded trials to be at high risk of bias, and downgrade the strength of recommendations where industry-sponsored trials represent an important part of the available evidence.”

The Food and Drug Administration recently approved duloxetine as a treatment for fibromyalgia in pediatric patients, largely on the basis of a small trial conducted by Eli Lilly, Cymbalta’s manufacturer. Children enrolled in the study did show a modest improvement in pain, but several of them had serious adverse events, including two attempted suicides, suicidal thoughts, an intentional drug overdose, depression and hallucinations.

In their published findings in the journal Pediatric Rheumatology, Eli Lilly researchers downplayed the adverse events associated with duloxetine, saying they were not drug related or “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

A common complaint of patients who take duloxetine is how quickly they become dependent and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms, including electric-like sensations called “brain zaps.”

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded nearly 35,000 cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 4,000 of those adverse events resulted in death.

Weather App Provides Personalized Pain Forecast

By Pat Anson, PNN Editor

Like many people who live with arthritis, Dave Richtor noticed that cold and wet weather made his joints ache more than usual.

“I’ve always just been stiffer and slower on grey days,” says Richtor, who lives in the seaside city of Brighton, south of London. “I’m in bed for ten hours a day. When I’m waking up and stiff, there’s obviously been in the night a temperature change.

“My grandma used to know when a storm was coming 20 minutes before it happened. She’d say, ‘Oh, a storm is coming. I’m getting a headache.’”

Feeling “under the weather” is more than just family folklore. Richtor was intrigued by a recent University of Manchester study called Cloudy With a Chance of Pain, which analyzed data from over 10,000 UK residents who recorded their daily pain levels on a smartphone app. The GPS location of their phones was then compared to local weather conditions.

The study found a modest association between weather and pain, with people more likely to feel muscle aches and joint pain on days with low barometric pressure – and the wet and windy weather that usually comes with it.

The study not only gave credibility to a link between weather and pain, it gave Richtor an idea. Why not create an app that gives users a personalized pain forecast? Many apps track the weather and some keep track of pain levels, but there were no apps that married the two.  

“I’ve done extensive research into it, and can’t see those two things matching up,” Richtor told PNN. “Most people I know in this field have been like, ‘Why hasn’t anyone done this before?’”

That’s the inspiration behind Weather Flare, a free health app designed to help people with chronic pain anticipate changes in the weather and their pain levels. Users create a personal profile of their conditions, medications and symptoms, which are then compared to weather conditions provided by AccuWeather. The app “learns” from user input and develops a customized forecast to help people prepare for changes in their symptoms. 

Richtor is currently holding a Crowdfunding campaign to raise money for further upgrades to the Weather Flare app.

Weather Flare is not just for pain sufferers. Richtor says people with asthma, allergies and other health conditions can benefit from knowing about weather conditions such as air quality and pollen counts.

He’s also working with a professor at the University of Sussex to develop a database to warn of drug interactions caused by the weather. For example, people with psoriasis who take methotrexate can be sensitive to prolonged sunlight.

“We’re incredibly excited to have the University of Sussex onboard to assist us with further developments for our app, making Weather Flare even more supportive for sufferers,” says Richtor. “The positive thing about me just having this crazy idea in my head, is that I can help other people manage their own conditions. If it just makes 1% of difference to someone’s day, then I’ve achieved what I set out to do.” 

The app is still in beta stage – meaning the developers are still working out some technical issues. When I downloaded the app, it was unable to recognize my location despite repeated attempts.

Weather Flare is not just for people in the UK. Because AccuWeather provides forecasts and weather conditions around the world, it can be used anywhere. To download the app, click here.

Migraine and Arthritis Patients Report More Pain During Pandemic

By Pat Anson, PNN Editor

Two new surveys are opening a window into how migraine and arthritis patients are managing their pain and getting treatment during the coronavirus pandemic. Many remain fearful about visiting a provider and want insurers to make access to medication easier.

The first survey, conducted by the Headache & Migraine Policy Forum, found a significant increase in stress and migraine attacks in over 1,000 U.S. migraine patients who were surveyed over the summer.

Asked how COVID-19 had impacted their health and treatment, over two-thirds (69%) of patients said they were experiencing an increase in monthly migraines. Eight out of ten (84%) said they felt more stress managing their disease (84%) and over half (57%) said their overall health had worsened.

“Treating a debilitating condition like migraine disease during a global pandemic can increase stress for patients, many of whom already struggle with day-to-day activities. Added stress can mean more frequent attacks, resulting in more visits to see a health care provider or even costly ER visits,” the Policy Forum said.

But while the frequency of migraine attacks increased, many patients were reluctant about seeing a provider and potentially exposing themselves to COVID-19. Six out of ten (61%) said they were afraid to seek care at a doctor’s office or hospital, and 74% were hesitant to visit an emergency room when having an acute migraine attack.

Some insurers have relaxed rules about prior authorization and step therapy to make access to medication easier during the pandemic. But most migraine patients say their own insurers need to be more flexible.

• 72% had difficulty managing their migraine because they couldn’t get a longer supply of medication

• 73% said insurers did not allow them to get more medication per pharmacy fill

• 70% said insurers did not reduce barriers like prior authorization

• 76% said insurers did not stop requiring step therapy

While migraine patients were often unhappy with their insurers, most were delighted with telehealth. The vast majority (83%) said they hoped their providers continued using telehealth after the pandemic ends.

“COVID has introduced a host of new challenges for people living with migraine disease. Telemedicine clearly provides an important link to care, but patients are looking for insurance providers to do more to facilitate care, including cutting red tape and ending delay tactics,” Lindsay Videnieks, Executive Director of the Headache & Migraine Policy Forum said in a statement.

Arthritis Patients Want New Treatments

The second survey of nearly 2,000 adults suffering from osteoarthritis had similar findings. Over a third of respondents (37%) told the Arthritis Foundation that they had missed or cancelled a doctor’s appointment due to fear of COVID-19 infection. Only 15% said their osteoarthritis is well managed.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. No disease-modifying drugs are currently available to treat OA, and over the counter pain relievers have only mild to moderate effects on OA pain.

"Pain is debilitating. My back and hip pain are so bad that I have trouble getting out of bed," said one survey respondent. "Each step is excruciating, and I wonder how much longer I can deal with the pain."

"You spend a lot of time & effort trying not to think about it because what you focus on magnifies," another patient wrote. "You hate pain scales because how do you rate something that is always there? Oftentimes it's not the pain's intensity but rather the duration."

Nearly two-thirds (65%) of patients said they use non-steroidal anti-inflammatory drugs (NSAIDs) or topical medication to manage their pain, 29% use physical therapy or massage, and another 29% said total joint replacement helped.

The primary change OA patients want is for insurers to increase coverage of new arthritis treatments, though more than half said they were only interested in a new treatment for pain if it didn't also increase their joint damage.

The Arthritis Foundation recently joined with 30 other healthcare organizations in asking the Food and Drug Administration and National Institutes of Health to make the development and availability of pain treatments a higher priority within the agencies.

Lancet Study Calls for Improvements in Pediatric Pain Care

By Pat Anson, PNN Editor

An international study by The Lancet has found that childhood pain often goes untreated, unrecognized and poorly managed, leading to chronic pain, disability and other negative consequences in adulthood.

The report by the Lancet Child and Adolescent Health Commission, led by the Centre for Pain Research at the University of Bath, found that too many children live with pain — even in developed countries — and calls for improvements in pediatric pain care, including diagnosis, pain management, social support and psychological treatment.

"Among health-care professionals, it is easy to agree that no child should experience pain if that pain can and should be prevented, avoided, or successfully treated,” said lead author Emma Fisher, PhD, a Versus Arthritis fellow at the University of Bath.

“In practice, however, we know there is ample evidence that children frequently experience preventable pain, and that in high-income settings, with advanced health-care systems and highly educated and regulated health professionals, children and young people experience pain that often goes unnoticed, unreported, or is not responded to, across healthcare including in the Emergency Department, post-surgical care, and in tertiary care.”

Childhood Pain ‘Swept Under the Carpet’

The report provides several examples of childhood pain not being recognized or treated adequately, such as what happened to Caitriona Roberts of Belfast, Northern Ireland. At age 12, she went to her doctor with pain and swelling in her ankle. Initially written-off as 'just a sprain' that would go away, she would spend the next six months living in almost constant pain, until she was referred to a specialist who diagnosed her with juvenile idiopathic arthritis, an autoimmune condition.

Now 28, Roberts has learned how to live and manage the disease. She helped researchers prepare The Lancet report.

"I think this issue has been swept under the carpet for too long. Still today, over 15 years on from my diagnosis with arthritis, I find people, including medical professionals, unaware of the condition or its effects on my day-to-day life. And when I speak to other young people, I find that sadly, very little seems to have changed in terms of how they experience pain or the support they receive,” Roberts said.

Researchers say up to 10% of young people experience chronic pain into early adulthood, with conditions such as arthritis, other types of musculoskeletal pain, recurring abdominal pain, and headaches.  

"This really matters, both for those experiencing pain and those around them but also across wider society. We know that chronic pain experienced in childhood is likely to feed through to adulthood and this has long-term health and economic costs associated,” said Fisher.

She called on providers and policymakers “to sit up and listen to the fact that too many of our young people are in pain and need help."

Myths About Opioids

One obstacle to getting that help is the stigma associated with opioid pain medication, particularly in the United States and Canada, where researchers say guidelines intended to control opioid use in adults are being “inappropriately applied to young people.”

“Substance use disorders and pain medication are both conflated in policy and in the media's portrayal of the North American opioid crisis,” the report found. “Through this media, public views have been influenced to consider opioids as drugs of addiction rather than pain medicine.  

“Health-care professionals, young people, and parents continue to hold misconceptions and believe myths about opioid use in pediatric patients, whereby the media depicts opioids as the villain and the underlying reason for substance misuse. Opioids have their place in pediatric pain medicine. In the context of the oversupply of opioids, childhood pain can usefully be considered a risk factor for long-term harmful exposure to opioids.”

More Than Growing Pains

The report found that improvements in pediatric pain care have come slowly. The last major intervention in the field came in the 1980’s, when it was recognized for the first time that babies experienced pain. Up until that point, a number of routine and major operations, including heart surgery, were carried out on babies without anesthetics.

"Parents tell us about the struggle they have convincing their GP that their child's illness is more than growing pains,” said Zoe Chivers, Head of Services at Versus Arthritis, which funded the report. “While the focus, attention, and dedication in providing quality services to children is consistently in place for conditions like cancer it's woefully absent for childhood arthritis and chronic pain.

"As a society we need to understand that dismissal of arthritis comes at high price and that adults and children living in pain with the condition should no longer be expected to pay it."

The study has four key goals: to make childhood pain matter, to make it understood, to make it visible, and to make it better. One recommendation is to make routine vaccinations less painful and stressful for children, such as allowing parents to be present during the injections and using topical analgesics.

"For many parents and children, a trip to the doctors for routine inoculations will be a stressful and painful experience. This does not have to be the case - we know how we can make the experience less painful for young people, but we're not doing it. This is just another example of how pain has been accepted as an everyday feature of growing up," said Fisher.

COVID-19 Lockdown Made Symptoms Worse for Pain Patients

By Pat Anson, PNN Editor

A new survey is providing some insight into how patients suffering from arthritis, fibromyalgia and other types of joint and muscle pain fared during the early stages of the coronavirus pandemic.

In late April, researchers at the University of East Anglia (UEA) surveyed 678 patients in the UK with musculoskeletal pain, asking how the pandemic impacted their well-being and access to healthcare. The online survey was conducted five weeks after the start of a nationwide lockdown in which at-risk patients were told to “shield” at home, avoid all social contact, and postpone or cancel non-urgent healthcare appointments.  

"When lockdown happened, we were worried that this may become a much greater problem - particularly for those with bone, joint and muscle pain,” said co-author Toby Smith, PhD, a professor at UEA's School of Health Sciences. “We wanted to know how the new restrictions might affect pain, and better understand who is most at risk of experiencing flare-ups, or reduced well-being due to social isolation and loneliness.

"Our results show that the coronavirus pandemic is a major challenge to people's health and well-being, both to young and older people.”

Over half the patients (53%) reported that their musculoskeletal symptoms had worsened since the start of lockdown. About a third said they had seen a general practitioner or hospital rheumatologist because their pain, stiffness and overall health had significantly worsened. Those who reported greater social isolation and loneliness were less likely to access healthcare.

The vast majority of respondents, over 88 percent, reported little difficulty getting medication during the lockdown, but nearly half (44%) needed the assistance of others to do it.

"Should further isolation measures need to be enforced as we have seen in some part of the UK as the pandemic continues, particular efforts should be made to protect and support the socially isolated as a vulnerable group,” said co-author Alex MacGregor, PhD, a professor at UEA's Norwich Medical School. "Healthcare providers should reach out to individual patients who do not come forward for advice, and who might be silently struggling with their disease.”

Due to a recent surge in coronavirus infections, British Prime Minister Boris Johnson recently tightened nationwide restrictions, ordering bars and restaurants to close by 10pm. More people are also being required to wear masks. Asked about reports the government was planning a “total social lockdown” in northern England and London, Johnson’s health minister told the BBC she wouldn’t rule it out.

The UK survey findings, published in the journal Rheumatology: Advances in Practice, are similar to those found in a PNN survey of over 2,200 patients in April. About 70% said they were worried about going to a hospital or doctor’s office and had postponed or cancelled a medical appointment. A little over half said social isolation made them feel lonely.