Tag: treatments

Eighteen months in a dermatomyositis drug trial

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When I was first diagnosed with dermatomyositis, I felt hopeless about the prospects of humankind ever developing a drug specifically for my orphan disease. What profit-seeking entity would throw money at a disease so rare it makes lupus look like a pandemic? What congressional representative could justify spending taxes researching an autoimmune condition that may not even exist in the district they represent?

Could I count on the benevolence of strangers? Should I expect self-interested organisms hellbent on survival to be interested in preserving, or at least, improving, a genetically malformed member of their species?

In fall 2019, I received a call from Mayo Clinic in Scottsdale, Arizona. A dermatologist there wanted to enroll me in a phase 3 clinical trial for a drug developed for dermatomyositis and other rare inflammatory conditions.

I jumped at the opportunity. Any new drug had a strong chance of being an improvement over the azathioprine I had been taking.

Becoming a guinea pig

When the trial started, many asked if I was nervous about ingesting a substance not yet approved by the Food and Drug Administration. The answer was a resounding no.

For one thing, dermatomyositis is life-altering and irritating enough that I would prefer side effects from any drug–including the azathioprine I already take.

Azathioprine is classified by the U.S. Department of Health and Human Services as a carcinogen. According to the Mayo Clinic dermatologist, spending 35 years on the medicine I have been on, azathioprine, virtually guarantees I will end up with skin cancer before I turn 70. Other studies confirm risks of skin cancer and lymphoma. The sooner I can rid my body of azathioprine, the better.

Even then, as an anarchist, an agency stamp on a drug means little to me. Many of the FDA-approved autoimmune treatments carry risks of depression, insomnia, even death. A woman with arthritis I used to work with on rituximab was hospitalized after the medicine caused Guillain-Barre syndrome. And there is not one autoimmune treatment on the planet that does not put the patient at risk for humanity’s latest afflictions, COVID-19 and monkeypox.

Even if all pharmaceutical companies cared about was money, they have no incentive to kill or harm their customers. And even if a company were okay rushing drugs to market in search of short-term gains, a single nasty side effect from a single drug could ruin a billion-dollar corporation. Profits would be spent settling lawsuits. Few doctors or patients would ever trust the company again.

Finally, the drug I tested, lenabasum, had entered phase 3 clinical trials. By the time a drug reaches this late phase, it has already undergone years of safety and efficacy testing.

Schedule I substances

Lenabasum is ajulemic acid, synthetic cannabinoid designed to attack the severe inflammation and muscle degeneration associated with dermatomyositis. Yes, it is derived from cannabis, making it a Schedule I substance. In short, that means the federal government recognizes no acceptable medical use for it. Merely possessing the drug can land you 10 years in prison.

I have no idea how exceptions for this work, especially in the era of marijuana legalization, but the trial drug was definitely treated like contraband. The pharmacist had to hand deliver it to the patient, me, inside the study coordinator’s office. I was required to sign that I received and accepted the drug. The pharmacist had to affirm she gave it to me.

Lost in the insanity of this procedure was that the manufacturer had removed the pscyhoactive component of cannabis, tetrahydrocannabinol (THC). And even if they had not, I can buy recreational or medicinal cannabis containing ample THC at a strip-mall shop 3 miles from my house.

Perhaps even more hilariously, during the height of COVID-19, Mayo Clinic was shut down to any non-emergency use, and the pharmacist started shipping the scheduled substance to my house. Adhering to the strictest DEA definitions, this meant the pharmacist, the mailman, Mayo Clinic, and the U.S. Postal Service, were trafficking drugs.

Less guinea pig, more zoo exhibit

When I started the trial in February 2020, the violet-red Gottron papules adorning my knuckles were severely inflamed. They alone qualified me for the trial and turned me into a traveling zoo exhibit for medical students. Little in patient life underscores how different you are from everyone else like being introduced to a parade of twenty- and thirty-somethings for the first time as a textbook example.

Little in patient life underscores how different you are from everyone else like being introduced to a parade of twenty- and thirty-somethings for the first time as a textbook example.

To track adverse reactions, every visit, I filled out a 150-question survey, most of which were about itching and mental health. They also drew about six tubes of blood for every lab visit. Unlike labs ordered by me or my doctor, I was never able to see any of my results.

Apart from these procedures, the bimonthly study visits varied little from any other medical appointments. Admittedly, I looked forward to my visits. I enjoyed talking to someone who knew more about dermatomyositis than me for once.

Answering the $30,000-per-year question

Three months into the double-blind drug trial, the papules had all but disappeared. Hair loss slowed down. My scalp barely ever itched. I was even able to decrease my daily dose of azathioprine. I thought for sure I was on the lenabasum and that it had worked.

I was wrong.

In June 2021, the study coordinator phoned to inform me Corbus Pharmaceuticals, the drug manufacturer, canceled the trial. They had not seen the results needed to justify spending millions more to develop and market a drug that would cost patients or insurance companies tens of thousands of dollars per year.

The study coordinator also told me I had been on a placebo. Any improvements the dermatologist, my rheumatologist, and I observed had nothing to do with the lenabasum.

Though I was mildly disappointed, this was actually good news. Not only had my immune system backed off, but it did so while significantly decreasing my dose of azathioprine.

Further, despite lenabasum containing no THC, throughout the drug trial, I felt drained and unmotivated. Because the study overlapped the social withdrawal from worldwide quarantines and one-size-fits-all policies to prevent the spread of COVID-19, no one can say for sure if the lenabasum caused those feelings. That said, other patients reported similar side effects. Regardless, I was happy to rid my body and mind of anything that had contributed to 14 months of lethargy.

It would have been nice if lenabasum truly worked, but even if it had, insurance companies would have been reluctant to cover such an expensive drug.

Would it have been nice if the new drug worked? Yes. But even if it had, I am not certain it stood a future. Insurance companies would have used any excuse to avoid paying the $30,000 per year lenabasum would no doubt fetch following FDA approval. That would include remaining on the azathioprine that had worked all along and could be bought at prices even developing nations could afford. Cancer risks be damned.

Dermatomyositis and dentistry

Posted on Posted in autoimmunity, dermatomyositis, dermatomyositis, lupus, treatmentsTagged , , , ,

I hate the dentist. The mere thought of the pick scraping my teeth and gums drives me wild like a dog forced to endure a high-pitched whistle. The memories of the drill hitting a nerve the dentist thought she numbed causes me to cringe like a child being force-fed once-boiled, week-old brussel sprouts. If ever you put a committee into a room and asked them to think of ways to torture human beings, most would suggest the dentist’s chair–picks, drills, giant needles into the cheek and all.

Taking medications to keep my immune system in check has forced me to return to the dentist at least twice in the next month.

Because of this, I have spent much of my adult life taking care of my teeth, brushing daily, twice yearly cleanings. The best I could ask of myself is to floss more frequently. Between my hygiene and being subjected to numerous municipal fluoride experiments, my teeth have been largely impervious. I’ve had maybe six cavities my entire life–most of which were during my teen years, when my parents paid the dental bills and a toothbrush was as foreign to me as bathroom cleaner.

I returned to the dentist Thursday only to find out I have five cavities, including a nasty deep one that will require removing the tooth’s root. My dentist was so surprised by the decay he asked me: Had I changed my diet? Was I taking some crazy medication? Had I stopped brushing in protest of the Trump administration?

Immunosuppressants and oral health

Six months of immunosuppressants have desiccated my mouth like border patrol to the Arizona deserts and leaving my teeth to the mercy of the bacterial cartels.

Dental plaque (a bacterial mass) loves to hide in the canyons, ridges, and crevasses in between my teeth. A healthy mouth can better fight them. The immunocompromised, which now includes me, have to stay vigilant.

I’m now paying the price for those times I was too tired or too lazy or too busy to floss. The cost: a root canal, a crown, and five fillings. This amounts to over $2,000 in dental work and four hours in the dental torture chamber.

Autoimmune diseases and oral health

Interestingly, this may not be my fault alone. According to Colgate, dermatomyositis itself could be the cause. Their one-pager on autoimmune diseases and oral health points out how these diseases can cause trouble with eating, swallowing, and dry out the mouth and lead to more cavities.

Dermatomyositis dries out the mouth and causes trouble swallowing, leading to more cavities.

That said, as my dentist and hygienist explained, the solution is better oral hygiene. Three or four cleanings per year could also help. That and spending the ides of March in the dentist’s office having my teeth repaired.

Corticosteroids, colds, and mental health

Posted on Posted in autoimmunity, depression, dermatomyositis, mental illness, treatmentsTagged , , , , , , ,

Tapering down my corticosteroids and battling a run-of-the-mill cold while on immunosuppressants have left me exhausted this week.

Corticosteroids like prednisone are a first-line treatment for dermatomyositis and other autoimmune diseases but they can have serious side effects, especially when used over multiple months.
Corticosteroids like prednisone are a first-line treatment for dermatomyositis and other autoimmune diseases but they can have serious side effects, especially when used over multiple months.

Side effects of corticosteroids

No one should be on moderate to high doses prednisone or any corticosteroid for forever. Long-term corticosteroid use has several side effects: cataracts, bone loss, easy bruising, muscle weakness, weight gain, high blood sugar, psychosis, infection, and heart disease. People with healthy immune systems should not use them more than a couple weeks. Not unlike heroin detoxification, anyone who does use them for more than a few weeks has to taper down to lower and lower doses until you ween yourself off them.

Interestingly, even short-term steroid use has positive temporary side effects: namely, steroid euphoria. When you take the drug, you feel happy, positive, like you can conquer the world.

You can also have surpluses of energy, functioning on five to six hours of sleep just fine. I actually started this blog last July, during one of my steroid highs.

Corticosteroids screw with my mental health

As you taper down, each subsequent smaller dose deprives you of that drug-induced happiness. Much like someone weening themselves off opiates, you become physically depressed.

For almost nine months, my doctors have been varying doses of corticosteroids, trying to ween me off, only to put me back on moderate doses when my other medications fail.

This has been a mental and physical health nightmare, causing me to feel, at times, bipolar. One month, I get 30 or 40 mg of prednisone each day. The next, I taper down to 20 mg. At one point, I was on only 12.5 mg per day. Lately, I am down to 17.5 mg, leaving me feeling depressed.

Battling a common cold while suppressing my immune system

I also had a cold this week, my second of 2019 (the last ruined my New Year and my vacation). Just the usual symptoms: nasal congestion, ear and headaches, dehydration, fatigue.

Unlike people with healthy immune systems, my body seems to slow down more when I get sick. Several of my coworkers were still functioning the whole week while infected with the same virus, while I had to take a day and a half off work. Tuesday, I did nothing but watch YouTube videos of chef knife reviews. I have not been to the gym in a week. I ate junk food trying to make myself feel better.

Positive note: Even if immunosuppressants like methotrexate, azathioprine, and hydroxychloroquine leave me down for the count when a cold strikes, prednisone is like Aleve (naproxen) or Advil (ibuprofen) on steroids (pun intended). I barely notice nasal congestion or ear aches after I take prednisone in the morning. At night, however, I struggled to breathe normally.

I feel much better today, but now I have a new concern: a new, unexplained allergic reaction.

Allergic reaction to methotrexate

Posted on Posted in autoimmunity, dermatomyositis, dermatomyositis, symptoms, treatmentsTagged , , , , , ,

Tuesday night, I had what my pharmacist describes as an allergic reaction to methotrexate. Within two hours of injecting it into my thigh, I developed nickel- and quarter-sized hives on my knee and elbow pits. My breath was short. My heart palpitated.

With any other patient, with any order condition, with any other drug, these symptoms would be a classic allergic reaction. Any doctor would tell you to stop taking it. When you’re dealing with autoimmune diseases, this could almost mean anything.

A classic allergic reaction is caused by the immune system’s hypersensitivity to a typically harmless substance. Treatment for such a reaction is usually a drug that mildly suppresses the immune system. For example, diphenhydramine (Benadryl) is an antihistamine that treats all sorts of mild allergy attacks and cold symptoms. It is a common ingredient in NyQuil and other over-the-counter cold medicines. Doctors use another common immune system suppressant, prednisone, to treat asthma and rheumatoid arthritis. I also take it to treat my dermatomyositis.

Methotrexate is a heavy-duty immune system suppressant. The irony of an immune system suppressant causing an allergic reaction was not lost on my pharmacist or my internist.

Such a reaction after being on the medication since October is odd, but according to my pharmacist, very possible. Also odd: shortness of breath is a symptom of untreated dermatomyositis. However, hives are not. And this is the second week I have had them after injecting myself with methotrexate.

Because I only take the drug once a week, I have already discontinued it. I made an appointment with my rheumatologist for next week. I will most likely switch to a different medication, most likely, another immune system suppressant, azathioprine.

Hydroxychloroquine staves off dermatomyositis symptoms

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Hydroxychloroquine (Plaquenil) staves off my dermatomyositis symptoms far better than I thought.

Hydroxychloroquine is cheap, relatively safe, and controls the heart and muscle inflammation associated with dermatomyositis.
Hydroxychloroquine is cheap, relatively safe, and controls the heart and muscle inflammation associated with dermatomyositis.

Hydroxychloroquine controls heart and muscle inflammation

This past weekend, I ran out of hydroxychloroquine, an antimalarial drug used to treat autoimmune diseases. By Monday, my heart started racing and palpitating. My lungs felt constricted. Both felt like they were on fire. My throat seemed to be closing, as though I had a piece of food stuck in it.

Doctors call these symptoms myocarditis and dysphagia, respectively. Basically, along with my skin and skeletal muscles, my immune system is attacking my heart, diaphragm, and throat muscles. Oddly enough, clinical tests show nothing. My resting heart rate is a healthy 55 beats per minute. My breathing tests were normal.

I also could hardly concentrate. Much like when you have the flu or are weight lifting, all you can think about is your body’s stress and pain. Much like when you feel anxious or drink too many double-shot espressos, your racing heart makes it tough to read and write.

I forgot all of these symptoms and have not experienced most of them since I started treatment in August. Because I mismanaged how much hydroxychloroquine I had left, they returned within 24 hours of exhausting my supply.

When refilling a prescription is worse than managing a proposal

Trying to understand refill procedures with my local pharmacy is like trying to communicate with project managers building the Tower of Babel.

Speaking of the ancient world, to remedy the situation, the pharmacist sent my rheumatologist a fax for the refill.

As a Denver Broncos fan, I know all too well the dangers of faxing in the 21st century, so I sent my rheumatologist a message through his online portal Monday. No response. I called the office Tuesday. His medical assistant’s voicemail says she will call back within 24 hours. She did not.

By Tuesday evening, I gave up and phoned my dermatologist, who is always on top of things. Within 45 minutes, the pharmacy cleared my refill.

Treating autoimmune diseases with hydroxychloroquine

Today, after taking 200 milligrams of hydroxychloroquine last night and this morning, my body is returning to normal. No more heart and lung issues. My throat feels less swollen. I will not mismanage my prescription again.

First developed in 1955 for treating malaria, hydroxychloroquine is the first-line treatment for dermatomyositis and lupus. Compared to other immunosuppressants, it has few side effects and is so safe pregnant women can and do take it. Better still, it costs next to nothing; even without insurance, a month supply is less than $25.

The only downside is long-term use of hydroxychloroquine can be toxic to your eyes. To make sure nothing like this happens, I take the recommended daily maximum dose and have an ophthalmologist as part of my care team.

Taking Otrexup: Stabbing Yourself to Save Your Life

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For all of the alleged benefits of treating dermatomyositis with Otrexup (subcutaneous methotrexate), Antares Pharma doesn’t make it easy to take. They instruct you to once weekly jam a needle in your stomach or thigh. They ship the drug in this ominous yellow bag warning you the contents are for chemotherapy. Every single injector pen comes with a set of instructions and warnings longer than most college essays. Then, they request you return the cartridges in a biohazardous waste container.

I am calling out Antares for their study claiming 98 percent of patients say Otrexup is easy to use. Is it easy to take off the safety and look at the injector pen? Sure. But stabbing oneself is never easy.

By the time you work up the courage to open an individual box holding the cartridge, you’re so paranoid about the possible damage to your liver or losing your hair that you feel like Eric in the sarin gas chamber in The Rock: “You want me to stick this into my heart? Are you fucking nuts?”

Otrexup: Four Weeks later, I still can’t Stab myself

Four weeks later and I still cannot bring myself to stab myself in the thigh. My girlfriend does it for me. Sometimes, she seems all too happy to do so. No matter how silent she stays, I can hear her evil cackle. I wonder if she is not-so-secretly a sadist.

My blood must also be tested monthly to check for live damage. This wouldn’t be too bad, except that as America’s population continues to age, every blood center in Phoenix is full of grouchy, impatient, lifeless geriatrics. Though my girlfriend will say I will fit right in.

Is Otrexup worth it? It’s too early to tell. My rashes have receded. My nose is less red (with any luck, I won’t be guiding Santa’s sleigh). I do not itch as much. I am breathing easier and getting a bit stronger, but that progress could be attributed to going back on a moderate dose of steroids.

Side note: Kudos to Antares Pharma for providing first-time Otrexup patients with a coupon for no co-pay for a year. Even with the best insurance, subcutaneous methotrexate is pricey. No, they did not pay me to say that.  The coupon is available on the Otrexup website to anyone with commercial insurance.

Autoimmunity, methotrexate, and alcohol

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Autoimmune patients taking methotrexate must avoid alcohol, according to most rheumatologists. So too say the makers of Otrexup (subcutaneous methotrexate). I messaged my doctor to double check: He agrees abstinence is best.

Not everyone agrees. Newer studies are changing some rheumatologists’ opinions. Many now say rheumatoid arthritis patients may consume alcohol in extreme moderation; in other words, a couple drinks a week is fine. Psoriasis patients, however, should avoid it.

So, where does that leave me? Since methotrexate is used off-label to treat dermatomyositis, all research on methotrexate and alcohol concerns psoriasis and rheumatoid arthritis patients. I can only trust my doctors and look at anecdotal evidence from other dermatomyositis patients.

Many myositis patients on online bulletin boards ignore doctors’ advice. “Live life!” they say. Others were told by their doctors a couple drinks a week is okay—just not on the same day as your injections.

One current complication for me is I am on prednisone and methotrexate. Both are hard on your liver. In fact, I can feel my liver throughout the day yelling at me. For me, until I get off the corticosteroids, alcohol is probably best avoided.

Time to add methotrexate

Posted on Posted in amyopathic dermatomyositis, autoimmunity, dermatomyositis, dermatomyositis, treatmentsTagged , , ,

My rheumatologist and dermatologist agree with the Mayo Clinic dermatomyositis guru: After ten weeks on hydroxychloroquine, with few results, I need to add methotrexate and folic acid to my regimen of medications and supplements.

Otrexup: subcutaneous methotrexate
I’ll now be injecting myself with methotrexate in the thigh once a week with a cartridge that looks like a Soviet torture device. And I’ll be taking one milligram of folic acid every day—2.5 times the amount pregnant women take to stave off birth defects.

Methotrexate suppresses the body’s immune system. Developed in the 1940s as a chemotherapy agent to treat cancer, in low doses, studies and clinics have shown it effectively treats many autoimmune disorders. It’s a first-line treatment for rheumatoid arthritis and a second-line treatment for psoriasis. (Interestingly, it also used to induce abortions.) The drug is affordable, generally safe, and well tolerated by autoimmune patients.

Only time will tell whether or not the methotrexate relieves any of my rashes and itching. Medical journals show mixed evidence of its efficacy. In this dermatology study, only 1 of 4 patients with amyopathic dermatomyositis, in this one, only 2 of 3. However, this 1998 study showed it helped all 13 patients, whether they had muscle involvement or not. This 2011 study also found methotrexate reduced skin lesions in 8 of 11 patients.

Risks of Methotrexate

Liver toxicity is a risk of taking methotrexate. Though most of the above studies tout few adverse effects, one cancer-dermatomyositis patient had hair loss. These doctors observed psoriasis and dermatomyositis patients are at higher risk to liver damage than those with rheumatoid arthritis.

That said, methotrexate side effects are much more common in cancer patients. They take much higher doses of it than autoimmune patients. Brain damage is a real possibility for them.
 
I talked to all three of my doctors about side effects and risks. All three say the medication is generally safe and not to worry. Issues listed online and discussed in medical journals mostly affect autoimmune patients also battling obesity, drug or alcohol misuse or abuse, or cancer.
 
I will need regular blood tests to check for early signs of liver toxicity before the drug causes irreparable damage.

 

Living on the edge while working on the frontier

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I manage and help write proposals at a university placed by the Times Higher Education in the world’s top 1 percent. Few places on earth are better for studying and advancing research in industrial, computer, electrical engineering; materials science; earth and space exploration; and biotechnology.

In doing my job, I see even before other academics and researchers how the world’s best scientists and engineers expand the frontiers of their chosen fields.

One engineer has a method for getting rid of dendrites in lithium batteries. I cannot say anymore than that, but in short, he and his partners know how to overcome one of physics and chemistry’s biggest obstacles to higher-capacity, longer-lasting lithium batteries in smartphones, drones, laptops, and electric cars.

A team of biochemists is folding nucleic acid nanostructures into geometrical shapes that can be used to reinvent biology on a nanoscale. Some day soon, they may be able to fold DNA and RNA—nature’s genetic instructions for life to grow, develop, function, and reproduce—into cures and treatments for cancer and infectious diseases.

My hope is they or someone else uses such methods to invent a cure for autoimmune diseases like dermatomyositis.

Living on the edge of what’s possible in modern medicine in a chaotic world seemingly controlled by corrupt institutions can be discouraging. Not knowing what cures and treatments await me induces as much anxiety as simply having the disease and as much frustration as dealing with hospital and insurance bureaucracies.

But it helps knowing such people are out there, looking at ways to improve humanity and society, to make our lives easier, is encouraging—especially for those of us waiting for a miracle.

Exercise and dermatomyositis

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Exercise is important for all of us. For me, it may save my life.

The worst symptom of dermatomyositis is muscle weakness. This happens because when you have myositis, anti-inflammatory cells meant for fighting infection attack your muscle cells. Over time, without regular use, your muscles waste away faster than they would in a healthy person.

Exercise is one of the best ways to combat the muscle deterioration caused by dermatomyositis.

This, of course, means I will have to give up my dreams of becoming a fitness model for a Slavic-language bodybuilding magazine or the National Football League’s oldest rookie wide receiver. Similarly, I will no longer be moonlighting as a piano-moving, tuxedo-clad male stripper. Sorry, ladies.

But muscles are not just for opening safety-sealed jars and trying to embody all that is man. You use muscles every time you move, talk, blink, wink, beat, or breathe.

The body’s diaphragm and external intercoastal muscles operate the lungs and help expand and contract our chest cavities. If these become weak, breathing becomes tough. If they get weak enough, you can’t breathe at all.

The heart is also a muscle. If your anti-inflammatory cells begin to attack it, without treatment, your heart would eventually fail. Fortunately, heart involvement in dermatomyositis only occurs in about 10–15 percent of patients. Fortunately for me, my last electrocardiogram revealed no abnormalities.

Exercise is important for all of us.

For me, it may save my life.

To keep my lungs and heart healthy and regain the lost strength in my muscles, they need to be exerted and stressed. They need to continue to break down and rebuild themselves to combat my immune system.

My whole life I have stayed active, so working out adds nothing new to my routine. At times, I lifted weights, ran, or played touch football with friends as many as five days a week. The last several years, I added protein or creatine or other workout supplements to help build muscle and soften the jump over age 30—at which point, almost all men start to see their athletic performance decline.

So I’m ahead of the game. And doing more of the same—exercising, eating well—can only help me for now. Plus, turns out, creatine supplements are a safe, relatively inexpensive way to improve muscle performance and function in dermatomyositis patients.