Autoimmune Disease Patients Struggle with Diagnosis and Costs

By Andy Miller, KFF Health News

After years of debilitating bouts of fatigue, Beth VanOrden finally thought she had an answer to her problems in 2016 when she was diagnosed with Hashimoto’s disease, an autoimmune disorder.

For her and millions of other Americans, that’s the most common cause of hypothyroidism, a condition in which the thyroid, a butterfly-shaped gland in the neck, doesn’t produce enough of the hormones needed for the body to regulate metabolism.

There’s no cure for Hashimoto’s or hypothyroidism. But VanOrden, who lives in Athens, Texas, started taking levothyroxine, a much-prescribed synthetic thyroid hormone used to treat common symptoms, like fatigue, weight gain, hair loss, and sensitivity to cold.

Most patients do well on levothyroxine and their symptoms resolve. Yet for others, like VanOrden, the drug is not as effective.

For her, that meant floating from doctor to doctor, test to test, and treatment to treatment, spending about $5,000 a year.

“I look and act like a pretty energetic person,” said VanOrden, 38, explaining that her symptoms are not visible. “But there is a hole in my gas tank,” she said. And “stress makes the hole bigger.”

Autoimmune diseases occur when the immune system mistakenly attacks and damages healthy cells and tissues. Other common examples include rheumatoid arthritis, lupus, celiac disease, and inflammatory bowel disease. There are more than 80 such diseases, affecting up to an estimated 50 million Americans, disproportionately women. Overall, the cost of treating autoimmune diseases is estimated at more than $100 billion annually in the U.S.

‘Patients Feel Dismissed’

Despite their frequency, finding help for many autoimmune diseases can prove frustrating and expensive. Getting diagnosed can be a major hurdle because the range of symptoms looks a lot like those of other medical conditions, and there are often no definitive identifying tests, said Sam Lim, clinical director of the Division of Rheumatology at Emory University School of Medicine in Atlanta. In addition, some patients feel they have to fight to be believed, even by a clinician. And after a diagnosis, many autoimmune patients rack up big bills as they explore treatment options.

“They’re often upset. Patients feel dismissed,” Elizabeth McAninch, an endocrinologist and thyroid expert at Stanford University, said of some patients who come to her for help.

Insufficient medical education and lack of investment in new research are two factors that hinder overall understanding of hypothyroidism, according to Antonio Bianco, a University of Chicago endocrinologist and leading expert on the condition.

Some patients become angry when their symptoms don’t respond to standard treatments, either levothyroxine or that drug in combination with another hormone, said Douglas Ross, an endocrinologist at Massachusetts General Hospital in Boston. “We will have to remain open to the possibility that we’re missing something here,” he said.

Jennifer Ryan, 42, said she has spent “thousands of dollars out-of-pocket” looking for answers. Doctors did not recommend thyroid hormone medication for the Huntsville, Alabama, resident — diagnosed with Hashimoto’s after years of fatigue and weight gain — because her levels appeared normal. She recently switched doctors and hopes for the best.

“You don’t walk around hurting all day long and have nothing wrong,” Ryan said.

And health insurers typically deny coverage of novel hypothyroidism treatments, said Brittany Henderson, an endocrinologist and founder of the Charleston Thyroid Center in South Carolina, which sees patients from all 50 states. “Insurance companies want you to use the generics even though many patients don’t do well with these treatments,” she said.

Meanwhile, the extent of Americans’ thyroid problems can be seen in drug sales. Levothyroxine is among the five most prescribed medications in the U.S. every year. Yet research points to some overprescribing of the drug for those with mild hypothyroidism.

A recent study, paid for by AbbVie — maker of Synthroid, a brand-name version of levothyroxine — said a medical and pharmacy claims database showed that the prevalence of hypothyroidism, including milder forms, rose from 9.5% of Americans in 2012 to 11.7% in 2019.

The number of people diagnosed will rise as the population ages, said McAninch. Endocrine disruptors — natural or synthetic chemicals that can affect hormones — could account for some of that increase, she said.

In their search for answers, patients sometimes connect on social media, where they ask questions and describe their thyroid hormone levels, drug regimens, and symptoms. Some online platforms offer information that’s dubious at best, but overall, social media outlets have increased patients’ understanding of hard-to-resolve symptoms, Bianco said.

They also offer one another encouragement.

VanOrden, who has been active on Reddit, has this advice for other patients: “Don’t give up. Continue to advocate for yourself. Somewhere out there is a doctor who will listen to you.” She has started an alternative treatment — desiccated thyroid medication, an option not approved by the FDA — plus a low dose of the addiction drug naltrexone, though the data is limited. She’s feeling better now.

Research of autoimmune thyroid disease gets little funding, so the underlying causes of immune dysfunction are not well studied, Henderson said. The medical establishment hasn’t fully recognized hard-to-treat hypothyroid patients, but increased acknowledgment of them and their symptoms would help fund research, Bianco said.

“I would like a very clear, solid acknowledgment that these patients exist,” he said. “These people are real.”

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

Patients Squeezed in Fight Over Costly Infusion Drugs

By Samantha Liss, KFF Health News

Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country.

The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms.

PAULA SHEPARD

But at times, she said, her treatments were delayed due to UnitedHealthcare’s white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I’m a 50-year-old woman and I have to use a toilet lift,’” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn’t mean insurers pass along savings to patients.

“I don’t think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They’re all trying to make money.”

The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn’s, cost on average $1,106 per unit in 2015 under hospitals’ traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

But the report also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.

Delays in Care

At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who receive regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital’s pharmacy director. Shepard was among them.

Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine comes in a nondescript package that doesn’t get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.

“They’re in pain, they’re uncomfortable,” Hollabaugh said. “They may be having symptoms that don’t allow them to go to work.”

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center’s size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university’s oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You’re talking about cancer patients that are getting life-threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn’t make any sense to me. It’s all stupid. It’s all lunacy.”

At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation’s roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug’s cost, according to the Health Resources & Services Administration, which oversees the program.

‘People Got Greedy’

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.

Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America’s Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer’s ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly’s recent session.

Shepard, though, won’t need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens’ in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

But after KFF Health News inquired about Shepard’s case, Marusic said UnitedHealthcare stopped white bagging Shepard’s medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard’s medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

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

Experimental Blood Test Could Improve Fibromyalgia Treatment

By Pat Anson, PNN Editor 

Finding effective treatment for fibromyalgia has always been problematic. The Food and Drug Administration has approved three drugs for fibromyalgia, but many patients find pregabalin (Lyrica), duloxetine (Cymbalta) and milnacipran (Savella) ineffective in treating the widespread body pain, fatigue, depression and “brain fog” that are common symptoms of fibromyalgia.  

A small pilot study suggests an experimental blood test for fibromyalgia – called FibroGENE -- could be used to determine which drug works best for each patient. Researchers at AMPEL BioSolutions and Duke University Medical Center found genetic biomarkers in the blood cells of 18 lupus patients with fibromyalgia-like symptoms. Their findings, published in the journal Lupus Science and Medicine, could lead to patients getting more effective, personalized treatment through genetic profiling.

“The bottom line is that we found the driving pathways for fibromyalgia that can be targeted by drugs that are already on the market,” said Amrie Grammer, PhD, Ampel’s co-founder and President.

“This is a disease management tool. This is meant for patients who know they have fibromyalgia, either on its own or in the context of another disease, such as lupus, and will be a game changer because treatment is often by trial and error. The doctor says, ‘Try this, let me know if it doesn’t work and try that.’ It often takes years, if ever, to get on a medication or medications that relieve the brain fog, the pain, etc.”  

Lupus is an autoimmune disease in which the body attacks its own tissues and organs, causing pain and inflammation. Like fibromyalgia, lupus is difficult to diagnose because its symptoms mimic those of other pain conditions. Genetic profiling of patients helps reduce the guesswork in treatment.

“The gene expression profiles of patients with fibromyalgia or type 2 lupus with fibromyalgia suggest both available drugs and new drugs that might be tested in patients with extensive pain and fatigue,” says study co-author David Pisetsky, MD, Rheumatologist and Professor of Medicine at Duke.

“Moreover, the gene expression profiles suggest a means to match patients with specific drugs. This opens a novel area of precision therapeutics for each individual patient rather than the trial and error approach currently employed.”

Larger studies are needed to prove the viability of Ampel’s blood test, but the company’s goal is to make FibroGENE commercially available by 2024 or 2025. Ampel is currently looking for fibromyalgia patients to participate in its clinical trials.

New Treatment Offers Hope for Lupus Patients

By Dr. Eric Morand, Monash University, Australia

When real patients have unprecedented positive outcomes to a new treatment, it’s tempting to talk about it as “breakthrough” for medical science. This describes the excitement around a new report from researchers in Germany of a radical new treatment for lupus.

The patients in the study – five people with severe lupus – went into remission following pioneering CAR T-cell treatment, which uses genetically altered cells.

What is lupus, why is this such big news, and what could it mean for other patients and diseases?

Around 5 million people are affected by some form of lupus worldwide. The most common form of lupus is technically known as systemic lupus erythematosus. Though not widespread, it is more common than multiple sclerosis (MS). Both are “autoimmune” diseases where the immune system attacks its owner instead of the germs it is supposed to fight.

MS is an autoimmune disease where the immune system attacks nerve tissue. In contrast, lupus can affect any organ in the body. Treatments for lupus have been so poor for so long that even wealthy and famous people with the disease – like pop star and actor Selena Gomez – have had organ failure resulting in the need for a kidney transplant. A lot of complicating factors have made it hard to improve outcomes for people with the disease.

Firstly, the variety of tissues lupus can affect means no two patients are exactly alike. Diagnosis is hard and often delayed. This also means we researchers have to deal with a lot of complexity as we try to work out what is causing the disease. This clinical variability makes measuring improvement in response to treatment difficult, and many clinical trials have likely failed due to measurement issues.

Second, there is variation between patients in which part of the immune system goes wrong. This means different patients will need different treatments – and we still do not know with certainty how to get this right. But progress is happening fast.

Innate and Adaptive Immunity

The immune system is in two parts, innate and adaptive.

The “innate” immune system responds fast but non-specifically to viruses and other germs that hit the body with a slug of germ-killing inflammatory proteins. The “adaptive” immune system is slower but more precise. It swings into action after the innate immune system and provides long lasting defense against the invading germ.

When you are vaccinated against a disease (such as COVID), the fever and aches you might get in the first day or two is your innate immune system at work. But the long-lasting protection from antibodies is provided by a part of your adaptive immune system, a key part of which is delivered by cells called “B cells”.

In lupus, both parts of the immune system are involved, and both have been successfully used to develop medicines. Earlier this year, the Therapeutic Goods Administration approved anifrolumab, a drug which blocks “interferon”, a crucial protein made by the innate immune system.

Another drug which works on B cells of the adaptive immune system, called belimumab, was approved a few years ago. Unfortunately, neither drug is on Australia’s Pharmaceutical Benefits Scheme yet, so access is extremely limited.

However, we now know that interferon and B cells are both important, and so very strong treatments that almost completely eradicate either could be useful. That is where this potential new treatment comes in.

Already Used to Treat Cancer

Treatments to destroy B cells are used in cancers like lymphoma. The most powerful of these uses CAR-T cells, which train a type of natural cell to be an assassin of the B cell.

CAR-T medicines are highly complex to make, and extremely expensive – but they work.

T cells are collected from the blood, then re-engineered in a special laboratory.

Now, this new report shows targeting B cells using this approach could be effective in lupus too. Building on a first-ever patient treated in this way by the same group a year ago, doctors in Germany created a “homemade” CAR-T treatment and used it in five patients with severe lupus.

Remarkably, all five patients had near complete eradication of disease, allowing them to stop conventional medicines, like steroids, with potentially harmful side effects.

What This Means for Other Patients

So what does it mean for patients in Australia? Well, most centres aren’t able to make their own CAR-T treatments, so delivering this potential treatment will require a commercial approach.

However, it might be quicker to market than other treatments in development as it takes a proven approach into a new disease, rather than being new from the ground up.

One day we might even be able to extend such treatments to other autoimmune diseases, like MS, where B cell-directed treatments have been helpful, as well as in lupus.

This would need to be balanced against risk. Importantly, short term side effects of CAR-T treatment (which include brain and bone marrow problems) can be severe. For this reason, such a treatment would only be used for the most severe cases in which standard treatments have failed, like the patients in the German trial.

Long-term side effects are also unknown at this time, and of course suppressing the immune system so profoundly in the setting of a pandemic is not without major risks.

Formal trials of a commercial CAR-T medicine for lupus are in the advanced planning stages already, and Australia is likely to be front and centre of these due to our lupus expertise and trial-friendly regulatory environment. With all these advances, we can at last tell our patients, and our friends and family with lupus, that there is light at the end of what has been a very long tunnel.

Eric Morand, MD, is a clinical rheumatologist and Head of the School of Clinical Sciences at Monash Health, Monash University in Australia.  Dr. Morand consults with companies involved in lupus drug development, including Novartis and AstraZeneca. He receives funding from Australia’s National Health and Medical Research Council and Lupus Research Alliance US, and is a Director of Rare Voices Australia.

This article originally appeared in The Conversation and is republished with permission.

Women Losing Access to Arthritis Drugs Due to Abortion Bans

By Pat Anson, PNN Editor

It didn’t take long for last month’s Supreme Court decision overturning Roe v. Wade to have a ripple effect on the U.S. healthcare system – including unintended consequences for women of childbearing age who have painful conditions such as lupus, rheumatoid arthritis, migraine and multiple sclerosis (MS).

Methotrexate and other drugs used to treat autoimmune and neurological conditions can also be used to induce abortions because they prevent cells from dividing. Although not commonly used for that purpose, methotrexate is officially listed in Texas as an “abortion-inducing drug” – an abortifacient -- putting practitioners at risk of running afoul of the state’s $10,000 bounty on anyone who helps a woman end a pregnancy after six weeks.

Even in states where abortion is legal, physicians, pharmacists and other healthcare providers have become cautious about prescribing or dispensing methotrexate.

“I received an email from my rheumatologist today that they are stopping all refills of methotrexate because it is considered an abortifacient,” a Virginia woman with lupus posted on Twitter just days after Roe was overturned. “If this is happening in a blue state with no trigger law, think of those in red states where abortion isn’t even legal. And those states that have trigger laws causing extreme and immediate loss of access.”

On the same day Roe was overturned, another poster on Twitter said his wife’s rheumatologist took all his female patients off medications that might cause a miscarriage

“So those patients are going to have to go off the drugs that were helping to control their condition and have worse health outcomes. People are going to die because of this,” he said.

The Lupus Foundation of America and Arthritis Foundation said they were aware of the situation and encouraged affected patients to contact them directly.

In an op/ed published in JAMA Neurology, neurologists at UC San Francisco School of Medicine warn the new abortion limits could have life-changing and life-threatening consequences for women with migraine, MS and epilepsy.

"Even if prescribed for a neurological condition, there are reports from patients across the country stating they are now unable to access methotrexate because it can also be used to induce abortion," wrote lead author Sara LaHue, MD, of the UCSF Department of Neurology. "This could increase risk of morbidity, mortality and irreversible disability accumulation for women with neurologic diseases."

Ironically, some treatments for neurological conditions also increase the likelihood of an unplanned pregnancy because they reduce the effectiveness of hormonal contraceptives. Physicians may become reluctant to prescribe those drugs to women of childbearing age.

Some neurologists may also rule out the use of monoclonal antibodies for women — not because they are used in abortions, but because they may harm a fetus.

"In many settings, women with MS are treated with less effective therapies, because these medications are perceived to be safer in pregnancy," said co-author Riley Bove, MD, of the UCSF Department of Neurology. "Often, neurologists are not familiar with how to time or optimize certain medications, or of their updated safety profile. The reversal of Roe v. Wade may reinforce decisions to stick with the less effective therapies, which may result in irreversible disability for some women with MS."

This week the Health and Human Services Department (HHS) warned retail pharmacies they are at risk of violating federal civil rights law if they deny women access to medications used in abortions. The warning specifically mentions methotrexate when its prescribed to someone with rheumatoid arthritis or some other disabling condition.

“If the pharmacy refuses to fill the individual’s prescription or does not stock methotrexate because of its alternate uses, it may be discriminating on the basis of disability,” HHS said..

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.

Lupus and Arthritis Patients at No Greater Risk from COVID-19

By Pat Anson, PNN Editor

Patients with lupus and other forms of arthritis are not at increased risk of being hospitalized with COVID-19 due to medications that weaken their immune systems, according to researchers at NYU’s Grossman School of Medicine.

Lupus, spondyloarthritis, psoriatic and rheumatoid arthritis are autoimmune conditions in which the body’s immune system attacks joints, skin, kidneys and other tissues, causing pain and inflammation. The arthritic conditions are often treated with steroids, biologics and other immune suppressing medications, which has raised concern that the drugs could also make patients more susceptible to risks from coronavirus infection.

But in two studies recently published in the journal Arthritis and Rheumatology, researchers found that most patients with arthritis had the same risk of hospitalization as the general population.

“People with lupus or inflammatory arthritis have the same risk factors for getting seriously ill from COVID-19 as people without these disorders,” said co-author Ruth Fernandez-Ruiz, MD, a postdoctoral fellow in rheumatology in the Department of Medicine at NYU Langone.

The first study involved 226 adult patients in New York City who were being treated for mild to severe forms of lupus between April 13 and June 1, when the coronavirus pandemic peaked in the New York City region. Forty-one of the lupus patients were also diagnosed with COVID-19. Of those, 24 were hospitalized and four died. Another 42 patients had COVID-19-like symptoms but were not formally tested.

The second study involved 103 women being treated for inflammatory arthritis between March 3 and May 4 in New York City. All tested positive for COVID-19 or had symptoms highly suggesting they were infected. Twenty-seven of them were hospitalized and four died.

Researchers say the lupus patients taking immune-suppressing medications such as mycophenolate mofetil (Cellcept) and azathioprine (Imuran), had no greater risk of hospitalization than patients not using the drugs. Similarly, hospitalization rates for people with inflammatory arthritis and COVID-19 were no greater than for all New Yorkers.

“Patients receiving therapy for lupus and inflammatory arthritis should not automatically stop taking their medications for fear that they would be worse off if they also caught the coronavirus,” said co-author Rebecca Haberman, MD, a clinical instructor in rheumatology in the Department of Medicine at NYU Langone.

Haberman and her colleagues say arthritis patients taking biologic drugs such as adalimumab (Humira) and etanercept (Enbrel), or the antiviral drug hydroxychloroquine, were also at no greater or lesser risk of hospitalization than those not taking the drugs.

However, arthritis patients taking glucocorticoids, a type of steroid, even in mild doses, were up to 10 times more likely to be hospitalized than patients not using steroids. The researchers caution that although statistically significant, the study’s small size may overestimate the actual risk from steroids.

“Our findings represent the largest of its kind for American patients with lupus or arthritis and COVID-19, and should reassure most patients, especially those on immunosuppressant therapy, that they are at no greater risk of having to be admitted to hospital from COVID-19 than other lupus or arthritis patients,” said Fernandez-Ruiz.

Risk factors that can double the risk of hospitalization from COVID-19 are having multiple health conditions, such as obesity, hypertension and diabetes.

Prescriptions for Anti-Anxiety Meds Surge Due to Coronavirus

By Pat Anson, PNN Editor

After weeks of isolation and the uncertainty of dealing with the coronavirus outbreak, it’s no surprise that many Americans are feeling depressed, anxious and not sleeping well.

“The trauma of a loved one being in the ICU, alone and not knowing if you'll ever see them again is horrific. It also adds to personal health anxiety,” one patient told us in our recent survey on the coronavirus.

“This is an extremely scary time. My anxiety is through the roof for many reasons,” another patient said. “I’m extremely worried I won’t pull through this or my husband and daughter won’t pull through this if they contract the virus! We’ve already lost my aunt and best friend both to coronavirus. One was 34, the other 62.”

“I feel more depressed and find my anxiety level is up. I worry most about getting my medications,” said another. 

New research from pharmacy benefit manager Express Scripts shows the stress is having a significant impact on the nation’s mental health. 

From February 16 to March 15, the number of prescriptions filled in the U.S. for anti-anxiety medications rose by a third (34.1%), along with antidepressants (18.6%) and anti-insomnia drugs (14.8%).

More than three quarters (78%) of the prescriptions were new – meaning they weren’t refills.

“As COVID-19 began to significantly impact the U.S., we observed an increase in the use of prescription drugs that treat mental health conditions, particularly commonly used anti-anxiety medications known as benzodiazepines,” Express Script said in a new report called “America’s State of Mind.”

SOURCE: EXPRESS SCRIPTS

The increased use of benzodiazepines such as Xanax and Valium is striking, because the drugs had fallen out of favor in recent years in large part due to fears that they raise the risk of respiratory depression and overdose when used with opioids.

Prescriptions for anti-anxiety medication rose more for women (39.6%) than men (22.7%) between February 16 and March 15, according to Express Scripts.

Hydroxychloroquine Shortages

Some patients with rheumatoid arthritis, lupus and other autoimmune diseases say their stress levels are up because they worry about losing access hydroxychloroquine (Plaquenil), a drug repeatedly touted by President Trump as a possible treatment for COVID-19.

“I am currently on Plaquenil for lupus and having Trump declare it is the cure for COVID-19 has limited my access to my medication. I am worried there won’t be enough,” a patient said.  

“No chronic pain patient should have to sit and have the anxiety from concerns on being able to have access to medication needed to treat their illness,” a rheumatoid arthritis sufferer said. “I am in a horrible RA flare at this moment. I have no doubt that the stress of being concerned about getting my needed medication has helped to bring this flare on. I am really concerned about being able to get my much-needed hydroxychloroquine. There is no reasonable explanation for drug shortages in this country other than ignorance.” 

“I have been on hydroxychloroquine for five years for my autoimmune disease and had never had an issue getting the medication until the virus. In March, I had to check 3 different pharmacies before I found one that had any in stock,” another patient said. “My usual pharmacy said that not a single one of their local chains had it in stock and that they were back-ordered. The pharmacy that did have it, was only able to do a partial refill.” 

When she told her doctor what happened, he agreed to write a 3-month prescription for hydroxychloroquine to make sure she’d have an adequate supply. Her insurance company, however, refused to pay for more than a month’s supply. 

“Not only do I worry about running out of medication, but each time I have to go to the pharmacy for various medications, I am exposing myself to others which could cause me to get the virus. As someone who has a compromised immune system, I want to leave the house as little as possible to avoid exposure,” the patient said.

On Friday, the Food and Drug Administration warned against using hydroxychloroquine or chloroquine as a treatment for COVID-19 outside a hospital or clinical study because of “serious and potentially life-threatening heart rhythm problems.” Patients with heart and kidney disease are especially at risk.

The FDA said patients taking the drugs for approved reasons, including malaria and autoimmune conditions like lupus, should continue taking them as prescribed.

Avoiding Coronavirus: Lessons Learned From People With Weak Immune Systems

By Anna Maria Barry-Jeter, Kaiser Health News

Andrea Amelse knows hand-washing.

For the past eight years, she’s been washing her hands pretty much every time she passes a sink. When she’s near a bottle of antibacterial gel, she uses it. She makes a point of avoiding people with contagious illnesses, even though it can be uncomfortable to ask to work from home or miss a date with friends. And she makes sure she gets plenty of sleep, not always easy at age 25.

Amelse was diagnosed in 2012 with lupus, an autoimmune disease that makes her vulnerable to infections. She’s since developed pulmonary arterial hypertension, a condition that requires intravenous therapy via a central line to her heart. Both illnesses place her at heightened risk for viral and bacterial illnesses. So, she has adapted as a matter of survival, taking to heart long-standing axioms on what constitutes good hygiene.

As the highly contagious new coronavirus continues its spread through the U.S., the general public could learn a thing or two from Amelse and the millions of other Americans with weakened immune systems who already live by rules of infection control.

Whether it’s people who had recent organ transplants, people undergoing chemotherapy or people with chronic diseases, America has a broad community of immunosuppressed residents who long ago adopted the lifestyle changes public officials now tout as a means of avoiding contagion: Wash your hands, and wash them often. Don’t touch your face. Avoid that handshake. Keep your distance from people who cough and sneeze.

Amelse doesn’t follow the advice perfectly — of course she touches her face sometimes.

“You do these things unknowingly, so forcing yourself to break these habits can be challenging,” she said. But the incentive to keep getting better is there. “If you get a cold and you give me that same cold, you might get it for a week. I’ll get it for a month.”

Even with her dedication, COVID-19 is proving a daunting prospect to face. And she has a stake in Americans adopting these habits because, while the disease is relatively minor for many people who get it, it can be life-threatening for people with preexisting conditions.

Amelse works at a health literacy startup in Minneapolis that helps patients with complicated diseases learn about their illness. She knows a lot about health and how to prevent infection. Still, the threat of COVID-19 is unnerving, for her and her doctors.

Stockpile Essential Supplies

With a virus so new, official guidance on what people at heightened risk should do to steer clear of COVID-19 is limited. But the Centers for Disease Control and Prevention recently said the virus seems to hit hardest in people 60 and older with underlying health concerns. There is also concern for younger people with limited immune systems or complex diseases.

Health officials are asking those at risk to stockpile two-week supplies of essential groceries and medicines in case they need to shelter at home; to avoid crowds and heavily trafficked areas; to defer nonessential travel; and to track what’s going on in their community, so they know how strictly to follow this advice.

Infection control always follows a similar set of principles, said Dr. Jay Fishman, director of the Transplant Infectious Disease and Compromised Host Program at Massachusetts General Hospital and a professor at Harvard Medical School. The most important things for people to do right now are the things he always recommends to his organ transplant and cancer patients. Again, think hand-washing and avoiding spaces where sick people congregate.

Still, the recommendations aren’t one-size-fits-all. Some people are born with stronger immune systems, and immune deficits exist on a spectrum, said Fishman. How strict people need to be to prevent illness can vary depending on how susceptible they are.

Avoid Crowds

Recommendations also need to take into account what people can and will do, he said. Children, for example, are among the greatest germ vectors of all time, but Fishman doesn’t ask his patients with grandchildren to stay away from their young family members. “We did the transplant so you can see your grandchildren,” he might tell them.

Similarly, avoiding crowds and staying away from sick people is easy for some but can be all but impossible if you work in food service, for example. Find ways to avoid the risks and reduce them where possible.

Though there isn’t great research on how well transplant patients and others manage to prevent infection, Fishman said many of his patients don’t get sick any more frequently than the general population, despite their vulnerabilities. But when they do, the illnesses tend to last longer, be more severe and put people at higher risk for additional infections. He counsels patients to be vigilant, but also to live their lives and not be ruled by fear.

Dr. Deborah Adey, a transplant nephrologist for UCSF Health, echoed Fishman, saying she likes to find ways to help her patients carry on with their lives. A patient recently asked if it was OK to fly to Salt Lake City, and she suggested they drive instead.

Gauging the risks can be tough. Amelse was relieved when a major health conference she was scheduled to attend recently in Florida was canceled at the last minute. She wasn’t sure it was safe to travel, but it also was unclear how to categorize an important work trip: Was this essential? Nonessential?

Adey conducts follow-up appointments via teleconferencing where possible, to keep her patients out of medical facilities. Hospitals are, by design, places for the sick, and people with compromised immune systems are generally advised to avoid them and the viruses and bacteria potentially inside.

That matches advice from officials in California and other states, asking people to stay out of emergency rooms unless absolutely necessary. They are asking people, when possible, to call ahead to their doctors and stay home unless an illness is serious.

Good Hygiene

And, similar to what public officials are advising the general population, Adey does not recommend that her patients wear face masks when out in public or even at the clinic. “The only people I would recommend is if they’ve got a lot of close contact with the general public, and they can’t afford to be off work.”

While much has been made of the hoarding sprees for face masks, the empty hand sanitizer shelves are equally frustrating for Amelse. Every 48 hours, she has to mix and administer drugs she places in an IV that goes into her heart. Everything must be sanitized, and she typically gets monthly shipments of antibacterial wipes and sanitizer. If suppliers run out, she’s worried she’ll have to go to a hospital to have the drugs administered — exactly where her doctors don’t want her to be.

Officials are desperately working on a vaccine for the coronavirus for use in as little as 12 to 18 months. But many vaccines are made from live viruses and can’t be given to some immunosuppressed people.

Given the risk COVID-19 poses for people with compromised immune systems, the government needs to stress how important it is for everyone to follow good hygiene protocols, said Fishman. “The worst thing we can do is downplay it.”

And for those just getting up to speed on preventing infections, Amelse has advice: “Viruses don’t pick and choose; they will latch on anywhere,” she said. Even if it’s not a serious illness for you, “there are people in your life that you can infect. You have the obligation and the responsibility to take care of your loved ones.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente. This story was first published on California Healthline, a service of the California Health Care Foundation.

Kratom Saved My Life

By Kim DeMott, Guest Columnist

I was diagnosed with lupus in 2013 after spending several years with unexplained chronic pain, debilitating fatigue and other awful symptoms. Lupus was the first of many chronic conditions that I would be diagnosed with in coming years, including fibromyalgia, Sjogren’s syndrome, osteoarthritis, osteoporosis, carpal tunnel syndrome, migraines, endometriosis, interstitial cystitis, chronic fatigue, chronic pain, anxiety and depression.

To treat these conditions, I was prescribed 28 different medications a day, including massive amounts of powerful opiates like oxycodone, hydrocodone and morphine, along with high doses of benzodiazepines such as Ativan, Xanax and Klonopin.

Even though I was taking all these medications, I was still in pain, had bad anxiety and no quality of life. I was housebound and practically bedridden (or at least couch-ridden) most days.  I had to use a cane, walker and even the walls in my house to walk on the really bad days, which is no way for a young woman and mother of two to live.

My health became so bad that in the fall of 2014 my doctors labeled me permanently disabled and told me to get in-home support services and file for SSI. I was only 29 years old.

I would have to tell my kids that mommy was in too much pain and too tired to take them to the park, play with them, pick them up, take them to school or be involved in any of their activities. This caused me and them to miss out on precious time and memories we can’t ever get back.

I couldn’t cook, clean, drive, go to the store or even go for a quick walk. They would see and hear me hiding in the bathroom or bedroom crying from the pain and the feeling of failure I felt as their mom.

I couldn’t take a shower, brush my teeth and get dressed in the same hour because I would have to rest after every task I did. Getting dressed consisted of putting on clean pajamas, because that’s the only thing that wouldn’t hurt to wear. I became isolated and depressed. I stopped answering my phone, texts, messages and emails.

KIM DEMOTT

The medications that the doctors put me on made me gain a ton of weight and made me feel incredibly dizzy, sleepy, forgetful, sick to my stomach and like I was in a fog. These side effects led to even more medications being prescribed, which meant more pills to add to the already huge amount I took daily. I was so depressed and hopeless that I actually attempted suicide a few times.

For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable.  

I am in no way cured and my pain is not completely gone, it never is and never will be. But the discomfort is down to a level that I can deal with, live with and function at. I still have bad days, but they are nowhere near as frequent or as bad as they used to be.  

Kratom has greatly improved my quality of life and dramatically changed it for the better. I’m not spending every day on the couch or in bed anymore and my kids have their mom back. We are doing so much more together.

Not only are my kids happy, but so are my fiancé, family and friends. Everyone tells me they have seen a huge change in me and that I am much more like the old me, which is something I have longed for since everything started. For the first time in years I don't feel like a prisoner in my own body and like my chronic illnesses and pain control me.

I am healthier, happier, take better care of myself and eat better. I’ve also been able to lose weight since I can cook and exercise again because I have better mobility. I even feel confident that I will be able return to work again someday soon and plan on returning to school this year.  

I look forward to each day and excited for what the future will bring. Most importantly, I am setting a better example for my kids. All thanks to this plant. Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today.  

Kim DeMott lives in California with her two children.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Nerve Stimulator Approved for Cluster Headache

By Pat Anson, PNN Editor

A neuromodulation device that stimulates a key nerve in the neck has been cleared by the U.S. Food and Drug Administration as a treatment for the prevention of cluster headache.

The handheld device – called gammaCore – is the first and only product cleared by the FDA for the prevention of cluster headache. It has already been cleared for the relief of pain caused by cluster headaches and migraines.

Cluster headaches are a series of short but extremely painful headaches that can occur every day for weeks and months at a time. They strike suddenly and subside quickly, but are so severe they’ve been called “suicide headaches.” Men are more likely to get cluster headaches than women. The cause is unknown and there is no cure. Recommended treatments for cluster headaches are limited to oxygen and triptan. 

“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache,’” said Frank Amato, CEO of electroCore, the maker of gammaCore.

“We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”

gammaCore is available by prescription only but can be self-administered by patients. It sends a mild electric charge to the vagus nerve in the neck, which stimulates the nerve while reducing pain. It’s recommended that the gammaCore be used twice daily to prevent cluster headache and reduce its severity.

ELECTROCORE IMAGE

The $600 device also has regulatory approval for the treatment of cluster headache, migraine and medication overuse headache in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada. 

Potential Treatment for Lupus

The vagus nerve is the longest cranial nerve in the body, running from the base of the brain through the neck, heart, lungs and abdomen. In addition to cluster headache, scientists think vagus nerve stimulation (VNS) could be useful in treating a variety of chronic pain conditions.

FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

In a small pilot study at the Feinstein Institute for Medical Research, researchers found that VNS significantly reduced pain and fatigue associated with lupus, an autoimmune disease that damages joints, skin and internal organs. Musculoskeletal pain is one of the most common lupus symptoms, affecting up to 95 percent of patients.

Feinstein researchers used an experimental device to stimulate the vagus nerve through the ear. Lupus patients who were treated with the device for five minutes daily had a significant decrease in pain and fatigue after just five days.

“Previous studies at the Feinstein Institute have found that under certain conditions, stimulating the vagus nerve can reduce inflammation,” Timir Datta-Chaudhuri, PhD, wrote in an email to PNN.

“With inflammation being a factor in many conditions, the vagus nerve could be used as a therapeutic target for conditions beyond lupus, and potentially for pain, when inflammation is a contributing factor. In fact, this discovery has been used in the past to develop bioelectronic devices which have been tested in clinical trials in Europe and shown to be effective in reducing the joint pain and inflammation in rheumatoid arthritis.”

Datta said there are plans to continue testing the device in clinical trials. If the results are positive, the Feinstein Institute would seek to partner with other labs and companies to create a device for wider use.

Childhood Abuse Raises Lupus Risk for Adult Women

By Pat Anson, PNN Editor

Women who experienced physical or emotional abuse as children have a significantly higher risk of developing lupus as adults, according to new research presented at the annual meeting of the American College of Rheumatology.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that causes inflammation in multiple organs. Most patients have times when the disease is active, followed by times when the disease is mostly quiet and in remission. Lupus is far more common in women than men.

“In prior work, exposure to stress and stress-related disorders, notably post-traumatic stress disorder, has been associated with increased risk of subsequently developing autoimmune diseases, including lupus,” said lead author Candace Feldman, MD, an Assistant Professor at Brigham and Women’s Hospital/Harvard Medical School.

“Exposure to adverse childhood experiences has specifically been associated with higher levels of inflammation, as well as with changes in immune function.”

To identify what kind of childhood trauma raises the risk of lupus, Feldman and her colleagues looked at health data for over 67,000 women participating in the Nurses’ Health Study II, an ongoing study of female nurses that began in 1989. There were 93 diagnosed cases of lupus among the women.

In detailed questionnaires, the women were asked whether and how often as children they experienced physical abuse from a family member, or yelling, screaming or insulting remarks from a family member. The women were also asked to recall incidents of sexual abuse by either adults or older children.

Researchers found that physical and emotional abuse were associated with a more than twofold greater risk of developing lupus. But the data did not reveal a statistically significant association between sexual abuse and lupus risk.

“The study’s findings suggest that the effects of exposure to physical and emotional abuse during childhood may be more far-reaching than previously appreciated,” said Feldman. “The strong association observed between childhood abuse and lupus risk suggests the need for further research to understand biological and behavioral changes triggered by stress combined with other environmental exposures. In addition, physicians should consider screening their patients for experiences of childhood abuse and trauma.”

This is not the first study to find an association between childhood trauma and chronic illness in adults. A recent study of 265 adults in New York City found that those who experienced more adversity or trauma as children were more likely to have mood or sleep problems as adults -- which in turn made them more likely to have physical pain.

Another study found that children who witness domestic violence between their parents are significantly more likely to experience migraine headaches as adults. A large survey also found that nearly two-thirds of adults who suffer from migraines experienced emotional abuse as children.

Why Are They Being So Cruel?

By Debbie Duke, Guest Columnist

I am 63 years old and have been on pain meds consistently since the age of 38.  I have systemic lupus and scleroderma, which fortunately is in remission.  I also suffer from gout, fibromuscular dysplasia, scoliosis, kidney pain and post-operative pain from breast cancer surgery.

My experience with pain management doctors in the beginning was very pleasant and I was getting relief from my agony. I was disabled but still functional due to pain medication. 

But recently things have changed.  After several years of using a pain pump, I decided to go back to oral medication to have more control.  The pump was not that effective for breakthrough pain and made me feel disconnected. After giving up on the pump, I changed doctors and the new one gave me the medication I had been before.

On my last visit, he said a new law requires patients on pain meds to have no more than the equivalency of 90mg of morphine.  Then he cut my dose in half.  I am now in agony and can see why people would turn to other ways of getting relief or decide to end it all. 

I love life and have many reasons to live. I care for a grandchild who had nearly been lost to foster care. Now, due to my inability to get around very well, I may not be able to continue taking care of her. 

DEBBIE DUKE

I can't bear to think of it. 

Why are they being so cruel to those of us who are law abiding, while the crooks get away with it?  When someone grabs grandma's meds from her purse or medicine cabinet, why is that grandma’s fault? 

Overdoses have been around for years and years. Who did we blame?  The one who stuck the needle in their arm, that's who.  Yes, we have a drug epidemic, but do something about the drugs coming across our borders. There has been enough squeezing of patients. Give them what works for them.  It sickens me to see patients treated unjustly turning to other ways to help themselves.

I'm truly afraid that everything in my life as I know it will end.  Thanks to irrational politicians who have taken away our right to be as free of pain as possible.

I think sometimes about what will be said in the future.  We'll be saying, “Remember the days when we were able to have pain relief and no one had to suffer?”

I know that people are dying, but to equate prescriptions with illegal drugs to make some political point is wrong. I wish those that are in pain could march down Pennsylvania Avenue. But we are too sick for that. 

Debbie Duke lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Osteoarthritis Drug Works No Better Than Placebo

By Pat Anson, Editor

Hydroxychloroquine (Plaquenil) is a medication commonly used to treat rheumatoid arthritis, lupus and other autoimmune diseases. It’s also being prescribed off-label to treat inflammation and pain caused by hand osteoarthritis, a joint condition that affects nearly a third of patients over the age of 70.

But in a new study published in the Annals of Internal Medicine, British researchers reported that hydroxychloroquine is no more effective than a placebo in relieving moderate to severe pain caused by hand osteoarthritis.

Researchers at the Leeds Institute of Rheumatic and Musculoskeletal Medicine and the Leeds Biomedical Research Centre randomly assigned 248 patients with radiographic hand osteoarthritis to either hydroxychloroquine (200 to 400 mg) or placebo for a year.

Most of the patients had symptoms of hand osteoarthritis for about 5 years, and their average pain level was 7 out of 10.

After 3, 6 and 12 months, there were no significant differences in treatment outcomes between the hydroxychloroquine and placebo groups.

“We found that HCQ (hydroxychloroquine) was not a more effective analgesic than placebo when added to usual care in persons with moderate to severe hand osteoarthritis,” researchers reported. “Background analgesic use did not differ between groups, and baseline inflammation and structural damage did not affect response to HCQ. The study therefore presents no evidence that HCQ should be considered within the management plan of patients with hand osteoarthritis.”

Two doctors who reviewed the study say more research is needed to find drugs that can treat the inflammation caused by hand osteoarthritis, a condition for which there are no effective therapies.

“The negative findings in this carefully done trial beg the question of what went awry. Did HCQ fail to reduce inflammation, or did reduced inflammation not translate to pain relief?” wrote Elena Losina, PhD, and Jefferey Katz, MD in an editorial.

“Although HCQ is safe, it is also a weak anti-inflammatory agent seldom used in contemporary practice as a solo disease-modifying therapy for rheumatoid arthritis and other inflammatory conditions. Further therapeutic studies of the effects of anti-inflammatory therapy on nodal hand osteoarthritis will need to use more potent agents or compounds developed to more specifically target the inflammatory pathways documented in this condition.”

Common Medical Conditions Linked to Fibromyalgia

By Lana Barhum, Columnist

People with fibromyalgia are more likely than others in the general population to have other chronic conditions. But doctors have yet to figure out why fibromyalgia often coexists with other diseases – what’s known as “comorbidity.”

Fibromyalgia sufferers often have migraines, autoimmune diseases, irritable bowel syndrome, depression, anxiety and sleep disturbances. Having multiple overlapping conditions isn’t easy, and increases physical pain and suffering. 

It is important for all of us with fibromyalgia to learn about these conditions and their symptoms.  Being knowledgeable about them will help us and our medical providers better control our symptoms, pain and overall health. 

Here are several common medical conditions faced by people who also have fibromyalgia:

Migraines:  Research indicates migraine sufferers are more likely to have fibromyalgia. One study from 2011, published in The Journal of Headache and Pain, suggests migraine headaches may even trigger fibromyalgia. Researchers believe preventing migraine headaches could potentially stop or slow down the development of fibromyalgia in some people, or minimize symptoms in fibromyalgia sufferers.

"These results suggest different levels of central sensitization in patients with migraine, fibromyalgia or both conditions and a role for migraine as a triggering factor for FMS. Prevention of headache chronification in migraine patients would thus appear crucial also for preventing the development of fibromyalgia in predisposed individuals or its worsening in co-morbid patients,” Italian researchers reported.

Autoimmune Diseases:  In about 25% of cases, fibromyalgia co-exists with an autoimmune condition, according to the Centers for Disease Control and Prevention.  Two serious autoimmune diseases that may accompany fibromyalgia are rheumatoid arthritis (RA) and lupus. 

Other studies show at least 20% of RA patients also have fibromyalgia, but researchers have yet to understand the connection. The pain of RA can trigger fibromyalgia flares, worsen pain and symptoms, and vice versa. 

In 2016, researchers in the UK tried to determine whether RA patients who also had fibromyalgia had lower levels of joint inflammation.  The results of their study, published in BMC Musculoskeletal Disorders, determined RA patients with fibromyalgia had "widespread soft tissue tenderness but fewer clinically inflamed joints, have higher disease activity scores but may have lower levels of synovial [joint] inflammation."

The researchers suggested that different approaches to treatment may benefit these patients.

"These patients are less likely to respond to escalation of inflammation-suppressing therapy and may be more suitable for other forms of treatment including alternative means of pain control and psychological support,” they wrote.

It is also not uncommon for lupus and fibromyalgia to co-occur.  However, fibromyalgia is no more common in lupus than other autoimmune diseases, according to researchers out of the National Data Bank for Rheumatic Diseases. 

Depression and Anxiety: People with fibromyalgia frequently experience depression and anxiety.

According to a 2011 report published in the journal Pain Research and Treatment, 90% of fibromyalgia patients have depressive symptoms at least once, and 86% of those people may suffer from a major depressive disorder. Depression and fibromyalgia occur at the same time in at least 40% cases -- a connection that researchers are still trying to understand.

The prevalence of anxiety symptoms in fibromyalgia patients ranges from 13% to about 71%,  according to Portuguese researchers. 

Irritable Bowel Syndrome: A majority of fibromyalgia patients – up to 70% - also suffer from irritable bowel syndrome (IBS), a digestive disorder characterized by abdominal pain, cramping, bloating, diarrhea and constipation.

Sleep Disturbances:  Most people with fibromyalgia report problems sleeping.  No matter how long they sleep, theyrarely feel rested. Restless leg syndrome, non-restorative sleep, and sleep apnea are all sleep issues associated with fibromyalgia.

People with fibromyalgia are more likely to have restless leg syndrome (RLS) than others in the general population, according to a study from the American Academy of Sleep Medicine (AASM). RLS is a disorder that causes uncomfortable feelings in the legs and/or the urge to keep moving the legs. The AASM study, published in the Journal of Clinical Sleep Medicine, finds 33% of people with fibromyalgia also have RLS.  

Up to 90% of fibromyalgia patients experience non-restorative sleep, a feeling of not getting refreshing sleep, despite appearing to have slept.

A 2013 study published in Clinical and Experimental Rheumatology reports that 61% of men with fibromyalgia suffer from sleep apnea, as well as 32% of women. Sleep apnea is a serious sleep disorder where breathing is interrupted during sleep.  

Living with Fibromyalgia and Co-Existing Conditions                 

In addition to suffering from fibromyalgia, I also suffer from three co-existing conditions -- rheumatoid arthritis, depression, and anxiety.  Having both RA and fibromyalgia, I have struggled with more severe symptoms, including muscle and joint pain and cognitive issues.  I know dealing with this debilitating pain results in both depression and anxiety, and both have been frequent visitors to my life.   

I am aware of the effect multiple conditions have on my well-being, and work hard at improving my overall health. I know I can still have a good quality of life, despite the many obstacles that fibromyalgia and its multiple co-occurring conditions present. 

There are other conditions linked to fibromyalgia that I have not mentioned, but they are still significant. Understanding how fibromyalgia and these conditions coexist may someday help researchers develop better treatments for fibromyalgia. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.