Tag: biologics

What are biologics and why are they so expensive?

[ad_1]

If you watch TV and don’t mute ads, you’ve probably heard of a few biologics. They’re drugs such as Humira for arthritis and Trulicity for Type 2 diabetes.

You may also know they are expensive. Biologics represented 5% of the drugs prescribed in the U.S. in 2024, but they accounted for more than half of the country’s total prescription medicine spending, according to health data analysis company IQVIA.

The Trump administration said it hopes to make these medications more affordable partly by increasing access to “biosimilars,” or highly similar products. What are biologics and biosimilars and will the administration’s proposals help drive down their costs?

Q: What are biologics?

A: Biologics is short for biological medications or products. It’s a broad category of products that include vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders.

Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Association for Accessible Medicines’ Biosimilars Council, an industry group that advocates on behalf of biosimilar manufacturers.

The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists to expedite COVID-19 vaccines, for example.

Q: What are biosimilars?

A: As the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and sold after the original biologic has lost its patent exclusivity, Keeton said. Biosimilars for Humira include Cyltezo, Amjevita and Idacio.

“They still work the same way, clinically, but they’re not exactly the same,” Keeton said.

That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their components are derived from live organisms.

“Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,” Chen said.

The FDA evaluates proposed biosimilar products against the original biologic to determine that the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic. To be approved, biosimilar manufacturers show that patients using their products don’t have new or worsening side effects compared with patients using the original biologic.

FDA approval for biosimilars often takes five to six years, Keeton said.

Biosimilars also increase market competition, incentivizing brand name drug manufacturers to lower their prices.

Q: How much do biologics and biosimilars usually cost?

A: They’re pricey, but exact costs vary.

One 2018 study found that biologics and biosimilars can cost a U.S. patient $10,000 to $30,000 each year on average.

Humira was listed at $6,922 in early November. The Humira biosimilar Cyltezo advertises for 5% off Humira’s cost; the makers of Cyltezo also offer a non-brand name option for people who pay cash at pharmacies while using GoodRx at a price of $550.

The actual amount an insured patient pays also depends on their plan and their insurer’s negotiated rates.

Biosimilar prices typically run 15% to 35% lower than their brand name biologic counterparts, one 2024 study reported. The FDA found biologics produce a more dramatic cost savings of 50% on average.

Q: Why are these medications so expensive?

A: Biologics and biosimilars are difficult to develop and produce, which adds to their expense.

Making a standard over-the-counter medication such as aspirin requires five ingredients. Making insulin, a biologic, requires genetic modifications to living organisms.

These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.

To put this in perspective, there were 226 marketed biologics in the U.S. as of July 2025, and the FDA had approved 76 biosimilars such as insulin. When it comes to non-biologic medications, the FDA has approved more than 32,000 generic drugs — that’s more than the number of approved brand name drugs.

Q: Can biosimilars be used in place of the original, FDA-approved biologics?

A: Yes. All biosimilars must meet FDA requirements and show that their products are highly similar and have no clinically meaningful differences from its existing FDA-approved biologic counterpart.

The Food and Drug Administration campus in Silver Spring, Md. on Oct. 14, 2015. (AP)

Q: So how does the Trump administration hope to change the FDA approval process for biosimilars?

A: Under its draft guidance, the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart.

Previously, a manufacturer requesting a biosimilar license had to provide clinical study data proving its product’s similarity. The FDA’s new proposal would no longer require drug developers to conduct these comparative clinical trials.

Manufacturers would still be required to test proposed biosimilars. Other data — including comparative analysis, immune response data and human study data showing how the drug moves through the body — could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.

Q: Why does the FDA want to change the biosimilar approval process?

A: Ultimately, the agency said it aimed to incentivize drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.

Saving that time might increase the number of biosimilar alternatives.

It will almost certainly lower the front-end development costs for drug makers, Chen said.

Q: Will that change lower the costs of these medications for patients who need them?

A: Regulatory changes alone may not significantly drive down prices for the average American.

Several non-brand name options need to be available in order to produce significant price drops, according to a Department of Health and Human Services report.

But prices could remain the same even with more options.

A 2024 JAMA Health Forum study found that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics.

That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others to manage prescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.

Q: Are there any other obstacles to getting more biosimilars on the market?

A: Yes, another key hurdle remains: Name brand biologic manufacturers often hold many patents and file lawsuits blocking approved biosimilars from being commercially marketed.

Chen’s 2018 study found that of 12 FDA-approved biosimilar products as of October 2018, five were commercially available. Six others were unavailable because of patent disputes.

PolitiFact Researcher Caryn Baird contributed to this report.

RELATED: Fact-checking Democrats’ talking points about Affordable Care Act subsidies

RELATED: Donald Trump exaggerates speed, certainty of prescription drug price reductions

[ad_2]

Source link

November 13, 2025
Advancements in Treating Atopic Dermatitis

[ad_1]

By Amy Paller, MD, as told to Stephanie Watson

Atopic dermatitis treatments have come a long way.

In the past, we had to use immune-suppressing drugs in people with moderate to severe disease. Many doctors, especially those without expertise in skin care, have used oral steroids. But we can’t keep people on these drugs long-term. Steroids cause serious side effects like weight gain and high blood sugar. They also have a rebound effect: The atopic dermatitis comes back pretty quickly, and with a vengeance.

Other immune-weakening drugs like cyclosporine, methotrexate, mycophenolate, or azathioprine have been the favorite of dermatologists. But these are also strong medications that need frequent blood tests to watch for side effects.

We needed a new treatment approach. Atopic dermatitis is a serious problem. The itch can be so severe that it keeps people up all night scratching. Severe flares can affect your ability to go to school or work and to have a social life.

It’s exciting to live in an age where we can create medications to target the pathways underlying diseases. That’s being done right now with atopic dermatitis.

Finding the Cause

From studies, we found that people with atopic dermatitis have an immune system imbalance. Their bodies make too much of certain things that inflame their skin when they’re exposed to irritants, bacteria, or allergic triggers like pollen and pet dander.

We know that the skin barrier is flawed in atopic dermatitis, which makes our skin-based immune system react more than usual when triggered on the surface. In addition, many people with atopic dermatitis do not have enough of an immune response against bacteria on their skin. All of these factors work together to trigger atopic dermatitis flares.

By understanding the driving forces behind the disease, we’ve been able to develop treatments that target the out-of-control immune system. Now, we can manage atopic dermatitis much better.

New Treatments

The FDA has approved two new treatments for atopic dermatitis in recent years. Crisaborole (Eucrisa) is the first phosphodiesterase-4 (PDE4) inhibitor. It’s a cream that blocks the enzyme PDE4 to reduce inflammation.

Continued

Dupilumab (Dupixent) is a biologic drug. It blocks the effects of proteins called cytokines that the immune system makes: interleukin-4 (IL-4) and interleukin-13 (IL-13). These contribute to the inflammation, reduced skin barrier, and severe itch of atopic dermatitis. Blocking them reduces the inflammation and the itch.

This drug has transformed atopic dermatitis treatment. Though it doesn’t work for everybody, in those it does help, it is life-changing. Sometimes, it starts to work in the first weeks after starting it.

The other advantage of dupilumab is its safety, especially in children. Immune-suppressing drugs like cyclosporine come with long-term risks like kidney damage and high blood pressure. That’s why we have to do regular blood tests in people who take these drugs.

With dupilumab, we don’t need to do blood tests. The only side effects are reactions where the needle goes in and possibly inflammation in the eye, which an eye doctor can treat. So now we can feel more comfortable treating patients safely.

Dupilumab has really been a game-changer. My patients tell me how it has changed their lives. Some of them hardly have to use the thick creams anymore to control the itch. They can play sports and go to parties again.

Coming Soon

Dupilumab is just the tip of the iceberg. Two more biologics should be coming out in the next year or so. Like dupilumab, they also target the effects of IL-13, and they have a similar safety profile. That means we’ll have more safe choices to prescribe for our patients.

The other group of medications for moderate to severe atopic dermatitis that’s coming out is the Janus kinase (JAK) inhibitors. These drugs block the messages that signal the immune system to make more cytokines.

Three JAK inhibitors are in development, and they look promising. One of them, abrocitinib, worked better than dupilumab in a head-to-head study.

Unlike injected drugs like dupilumab, JAK inhibitors come as a pill that you take daily. That is a huge plus for people who don’t want to get shots.

The big question is safety. Two JAK inhibitors that are used to treat rheumatoid arthritis and are in development for atopic dermatitis have a black box warning on the label about serious risks like cancer, blood clots, and infections.

None of these risks has come up in the studies on atopic dermatitis. But JAK inhibitors can cause nausea, headaches, acne, and higher odds of herpes infections, with risks depending on the drug. Also, people who take them will need blood testing to watch for problems.

Continued

New Topicals

A few new topical drugs — meaning you put them directly on your skin — are in development, including a topical version of a JAK inhibitor. We’re excited about these drugs because they’ll offer an alternative to topical steroids.

Another PDE4 inhibitor is also in the works, and it may be more potent than crisaborole.

Tapinarof is the first in a new class of topical drugs called a therapeutic aryl hydrocarbon receptor modulating agent (TAMA). It works in a different way to reduce the inflammation and itch of atopic dermatitis.

One problem for many people who use nonsteroid topical drugs that are currently on the market for atopic dermatitis (topical calcineurin inhibitors like tacrolimus and pimecrolimus; crisaborole) is burning or stinging. All of these new nonsteroid drugs seem to be less likely to cause these problems than ones we have now.

Another new treatment is a skin spray with healthy bacteria. These good germs fight off the bad bacteria that make atopic dermatitis worse and cause infection.

A few of these sprays are in development, and I think they will be very interesting to watch. They may be able to reduce inflammation and improve atopic dermatitis. Plus, I think a lot of people will like the fact that they’re natural — replenishing the “good bacteria” on the skin.

WebMD Feature

Sources

Photo Credit: yalax / Getty Images

SOURCE:

Amy Paller, MD, professor and chair of dermatology and professor of pediatrics, Northwestern University Feinberg School of Medicine.

Paller has done research on most of the medications mentioned in this story and has consulted for the companies that make them.

© 2022 WebMD, LLC. All rights reserved.

[ad_2]

Source link

October 19, 2023
Biologics for CSU: When Is it Time to Try?

[ad_1]

Is It Time to Try a Biologic for CSU?

091e9c5e820faac4091e9c5e820faac4FED-Footermodule_FED-Footer_091e9c5e820faac4.xmlwbmd_pb_templatemodule0144002/02/2021 01:57:340HTML

[ad_2]

Source link

December 27, 2022
Biologics for CSU: When Is it Time to Try?
[ad_1]

If you have chronic spontaneous urticaria (CSU), also called chronic hives, and treatments like antihistamines and steroids aren’t helping, you may be a good candidate for biologics.

What Are Biologics?

Biologics are medicines that target specific antibodies, molecules, and cell receptors that cause inflammation and may trigger an allergic reaction like CSU.

Omalizumab (Xolair) is the only FDA-approved biologic for CSU. It’s approved for adolescents and adults 12 years and older who have chronic hives. It’s a shot you get about once a month. It blocks IgE, the antibody that causes allergies.

When you first try a biologic, your doctor gives you the shot to make sure everything goes smoothly. “There’s about a 1 in 2,000 risk of having an allergic reaction to the medication, so the first several doses are administered in a physician’s office or [an] infusion clinic,” says Kara Wada, MD, an allergist and immunologist at the Ohio State University Wexner Medical Center in Columbus.

Your doctor may recommend that you keep taking your other CSU medicines at the same time.

Do Biologics Work Well?

Research suggests biologics are an effective treatment for CSU with a low risk of side effects.

In one study, more than 70% of the participants felt better within 24 weeks of taking a biologic. If a biologic helps with your CSU symptoms, you may also see improvements in your sleep quality, stress levels, and quality of life.

Biologics are considered low–risk for side effects, compared with immunosuppressant and anti-inflammatory drugs for CSU.
When to Try a Biologic

Your doctor may recommend a biologic if traditional CSU treatments aren’t working for you.

“Typically, I start considering a biologic if a patient is having daily symptoms that aren’t responding well to antihistamine medications,” Wada says.

With CSU, it’s best to take a step-by-step approach. The first step may be over-the-counter antihistamines. Your doctor may recommend higher doses of antihistamines than you would take for other allergies.

Your doctor may also recommend steroids or other immunosuppressive medicines for a short time.

“It may take a few weeks to have improvement,” says Viktoryia Kazlouskaya, MD, PhD, a dermatologist and dermatopathologist at Khrom Dermatology & Aesthetics in Brooklyn, NY. “Patience is key.”

If your body is resistant to high doses of antihistamines, your doctor may recommend a biologic.
What Biologics Are Available Now

Although omalizumab is the only biologic approved for treating CSU right now, there are more on the horizon. “Other biologics are being studied, but aren’t yet FDA-approved,” Kazlouskaya says.

Some doctors may use biologics that are approved to treat other conditions. This is called off-label use. They may try biologics like benralizumab (Fasenra), dupilumab (Dupixent), mepolizumab (Nucala), reslizumab (Cinqair), and secukinumab (Cosentyx) to treat CSU.

Researchers are studying the following biologics to see how well they treat CSU:

Benralizumab (Fasenra), mepolizumab (Nucala), and reslizumab (Cinqair). These medicines are approved to treat asthma, but not CSU.

Dupilumab (Dupixent). In a small study, this medicine helped people who didn’t respond to omalizumab.

Ligelizumab (QGE031). Like omalizumab, this is an antibody that binds to IgE.

Secukinumab (Cosentyx). This medicine may help people with chronic hives who don’t get relief from other treatment options.

Doctors hope to have more options as studies continue. With more biologics to choose from, doctors can use predictive biomarkers to choose which one is most likely to work for you.
What to Consider With Biologics

Though proven to have many benefits, biologics have also been shown to have several downsides.

Inconvenience. You may have to go to a doctor’s office every month to get your shot or IV. “If you’re low-risk, you may be able to do it at home,” Wada says, “but that’s less common.”
High costs. “Biologics also have a high price point,” Wada says. “Most people will need insurance coverage or will have to rely on the drug company’s copay assistance programs to help offset the costs.” On top of the biologic’s cost, you may also have to pay your doctor’s office or IV center for administrative costs if they charge any.

Long-term effect. Even though studies suggest biologics improve CSU symptoms, it’s unclear if they can change the long-term course of your CSU. If you take a biologic and decrease your dose or stop taking it altogether, it’s possible for your symptoms to come back. You might need to take a biologic for a long time to trigger remission.

Health Insurance Considerations

“Unfortunately, it’s very challenging to get biologics for patients with CSU, especially if they don’t have private insurance coverage,” Kazlouskaya says.

You may have to wait a few months for approval. Your health insurance company may require you to try a less expensive medicine first, even if it’s not effective for CSU.

Even if your health insurance approves a biologic, you may still have high out-of-pocket costs, depending on the type of plan you have. “Some high-deductible health care plans require that patients meet their out-of-pocket costs before coverage kicks in,” Wada says.

If you have Medicare, you may not qualify for copay assistance programs.

Biologics may work well and give you relief from CSU symptoms. But they’re not for everyone. Talk to your allergist about what’s right for you and whether it’s time to try a biologic.

[ad_2]

Source link
December 27, 2022
The Future of Autoimmune Disorders: Psoriatic Disease
[ad_1]
By Rebecca Haberman, MD, as told to Stephanie Watson

Psoriatic disease isn’t curable, but it is becoming more treatable. While not everyone can achieve clear skin or pain-free joints, things are improving with each new drug that we have to treat them with.

Our stable of drugs is growing exponentially, which is really important where one particular medication doesn’t treat everyone with the disease.

The diagnosis of psoriatic disease has also come a long way. It was under-recognized for a long time. It’s only been in the past 10 to 15 years that people have really begun to pay attention to it. Since then, it’s become easier to diagnose it.
Biologic Drugs

Psoriatic disease can be tricky to treat because it shows up in so many ways. Inflammation can affect:

Your joints

Where tendons and ligaments connect to bone (called the entheses)

Your fingers and toes

Your spine

Your skin

Your nails

While we think of psoriatic disease as one condition, it is possible that the diseases that make it up are a little different.
So it makes sense that we need different medicines to treat it. Older disease-modifying antirheumatic drugs (DMARDs), like methotrexate, target overall inflammation to slow the disease and prevent joint and skin damage.

A newer group of drugs called biologics has more specific targets within the immune system. They block certain proteins in your immune system that trigger inflammation. There are a growing number of these treatable targets, including ones called:
Trial and Error

No test can show which of these targets is best suited for you. So your doctor won’t know which of these drugs will work best against your disease until you try it.

The severity of your disease and which parts of your body it affects most (skin, joints, etc.) will help determine which medicine the doctor gives you first. For example, IL-17, IL-23, and IL-12/23 inhibitors seem to work especially well against plaque psoriasis.

Also important is whether you have other medical conditions that might make one biologic riskier for you than another.

But overall, prescribing these drugs can involve some trial and error.

The ultimate goal is to put you into remission, where you have no symptoms. But if you’ve lived with the disease for a long time, less pain, fewer swollen joints, and fewer skin plaques may be more realistic things to shoot for.

The Future of Treatment

Today’s treatments for skin lesions are more effective than the ones available for joint inflammation. Thanks to the wide range of topical medicines, biologics, and other therapies, we can get almost 100% clearance of the skin much easier than before.

It’s hard to achieve that with the joints. So we’re trying to come up with new ways to make people feel better.

The outlook for joint involvement may change as companies discover new drugs and they become available.

Drug companies are on the hunt for new ways to block inflammation in psoriatic disease. Some ideas involve combining biologics or targeting more than one inflammatory pathway at once. For example, a drug in development, bimekizumab, targets two inflammatory proteins, IL-17A and IL-17F. In studies, it helped some people’s symptoms improve by as much as 90%.

Researchers are also working on more personalized approaches to diagnosing psoriatic disease.

The ultimate goal is to get to precision medicine, where I can do a blood test and say, “This is how the patient is presenting and this is the medication that’s going to work.”

Rebecca Haberman, MD is a rheumatologist with NYU Langone Health in New York. She’s also a clinical instructor at NYU’s Grossman School of Medicine.

[ad_2]

Source link
December 19, 2022
Biologics for Psoriasis

[ad_1]

When Howard Chang, 50, first learned about biologic treatments for psoriasis almost 20 years ago, he was eager to give them a try. Now they’re a mainstay in his overall treatment plan.

Chang was first diagnosed with psoriasis around age 8. He tried lots of different treatments, including tar, phototherapy, topical creams and ointments, steroids, and oral medications.

“I definitely was always looking for the next new treatment, given that it was so hard for me to find anything that was effective,” Chang says.

He hoped biologics would provide much needed relief.

What Are Biologics?

Biologic drugs — often called biologics or biologic medications — work by changing parts of your immune system. You usually give yourself a shot. But some are given through an IV at your doctor’s office. The FDA approved the first two biologics for psoriasis in 2003. Now there are several options.

They’re generally prescribed for people with moderate to severe psoriasis, based on the amount of skin affected. But doctors also consider how psoriasis impacts a person’s life when deciding, says Malini Fowler, MD, a board-certified dermatologist in San Antonio, TX.

“There is no cookie-cutter candidate,” Fowler says. “Even if someone has mild disease, they are still probably a candidate for biologics, depending on how it affects their life.”

These drugs might also do more than just clear up your skin. They could help protect your heart, joints, and other body parts from inflammation.

“When we talk about using biologics, it’s a systemic medication treating (people) from the inside out, decreasing psoriasis on the skin, and hopefully helping with inflammation on the inside, too,” Fowler says.

What Are the Pros and Cons of Biologics?

Chang read up on how the drugs work, possible side effects and the risks when first considering biologics.

“Putting something in your body via an injection is something you have to think about, especially how it’s affecting your immune system,” Chang says.

Next, he spoke to his dermatologist.

“It’s key to have a dermatologist who understands the medications and also collaborates and connects with me as a (person),” Chang says. “We work on a plan together.”

While biologics can ease psoriasis symptoms, there are potential dangers, like with any drug. Some of them can up your odds for inflammatory bowel disease and cancer.

“You need to check if you have underlying cholesterol or hypertension problems,” Fowler says. “Every biologic medicine is slightly different; most of them have a different mechanism of action with different safety profiles.”

It’s important to tell your doctor about any other conditions you may have, so they can make sure the biologic won’t interfere with them or any medications you take.

Which Biologic Is Most Effective for Psoriasis?

Chang has tried six biologic drugs since 2003. One helped for about 8 years, but he had to switch up the rest because he couldn’t tolerate the side effects of some drugs, they stopped working after a certain period of time, or they just didn’t work at all.

While Chang says he knows many people who have achieved healthier skin with biologics, treatment hasn’t been as successful for him.

“I’ve never really been clear,” he says. “It’s not a cure. There are still triggers that can cause a flare.”

Finding a biologic that works for you can be emotionally draining.

“It’s a roller coaster ride. You keep hoping it’s going to work, and you wait for it to kick in. And then if it doesn’t work for you, it can be a big letdown,” Chang says. “Especially since [psoriasis] has such a big impact on my life. Sometimes, I feel like I can’t fully function because I have all of this physical discomfort when I’m running, working, teaching, meeting with people. I just want to be comfortable.”

Fowler likes to give a biologic 3 months to run its course.

“Not every medicine is going to work for every (person), but it’s also important to stick with the medications and give them a chance to see if they help,” she says. “I tell (them), ‘If this doesn’t work, we’ll go on to the next one. We will find the right medicine for you, but it may be a bit of trial and error’.”

Can I Take Biologics With Other Treatments?

Chang continues to use other psoriasis treatments, including topical creams and phototherapy.

“I feel better about things overall [with biologics], that I don’t have to do everything perfectly,” he says. “It feels a little better to know I have a medication that is working in the background.”

And he knows that managing stress, exercising, and eating healthy are critical to keeping flare-ups at bay. They do the same for metabolic syndrome, a group of conditions linked to stroke, type 2 diabetes, and heart disease. People with psoriasis have a higher risk of metabolic syndrome.

In addition to regular appointments with a dermatologist while on biologics, Fowler suggests keeping your primary care doctor in the loop, getting blood work done every year, and seeing a rheumatologist every 6 months.

“I also routinely ask patients about joint pain, because about 30% [of people with psoriasis] will develop psoriatic arthritis,” she says.

What’s Most Challenging About Taking Biologics?

One of the hurdles is learning how to inject the medications yourself.

“I think I’ve self-injected myself over a thousand times,” Chang says.

Luckily, the number of injections is significantly lower with newer biologic medications. Chang says he used to have to inject himself two times a week, but some injections can now be weeks or months apart, depending on the medication.

Chang came up with a routine to follow when giving himself an injection, from washing his hands and setting out all the materials, to ensuring he has something to watch in the background.

“It calms me to have a routine,” Chang says. “[Injecting yourself is] something you never completely get used to, but you get more skilled at.”

Another hurdle can be getting approval from your insurance company to cover different biologics.

Chang is hopeful that the biologic treatments for psoriasis and other options will continue to improve.

“It’s just a time to be really optimistic as someone living with psoriasis,” he says. “With all the research, medications, and advocacy, we have options and more coming.”

[ad_2]

Source link

October 24, 2022
My Journey With Crohn’s Disease: Coming to Terms

[ad_1]

By Christine Morris, as told to Susan Bernstein

I was 16 when I was diagnosed with Crohn’s disease. It was 2004. I was just a very sick

kid. Even as a baby, my mom told me that I had to be on soy formula because I was lactose intolerant. When I was older, doctors told my parents I had cyclic vomiting syndrome. This was a permanent thing where my diaphragm was hyperactive. If I throw up more than once, I can’t stop. I would just go on and on until there was nothing in my stomach anymore. I had to get fluids at the emergency room. I learned as an adult that I can get ahead of this as it starts. I take a drug called Zofran. It makes me drowsy, but the good thing is that it dissolves under the tongue, so you don’t vomit it back up.

Alien in My Stomach

It all started with those warning signs. Doctors said, “Well, maybe she is just more susceptible to catching stomach bugs.” At 13 or 14, I suddenly took a turn for the worse. I developed an intestinal blockage. Crohn’s had been doing damage to my small intestine for years. I missed almost a whole year of classes during my sophomore year of high school. I had vomiting episodes and severe abdominal pain.

We joked sometimes that I had an alien in my stomach, because it would rise and fall so heavily. I wore sweaters and sweatshirts to muffle the noise it would make. Through this whole process, I saw multiple doctors and had multiple tests, including colonoscopies and endoscopies that didn’t find anything. It was terrible.

Doctors would say to me, “Well, maybe it is psychological.” At that age as a girl, they were always thinking that my symptoms might be caused by an eating disorder. This condition can stunt your growth, too. I lost so much weight. I was unable to absorb any food or nutrients. I wasn’t developing at the normal rate a teenage girl should. I looked 12 at age 15.

At 15, we finally decided to try to see a pediatric gastroenterologist in Atlanta. I grew up in Rome, GA. Unfortunately, I didn’t have access to high-quality care there. With a more severe disease, we wanted to be seen by a specialist at a research hub. We drove an hour into Atlanta to see a specialist at Children’s Healthcare of Atlanta at Scottish Rite. He was one of the greatest doctors I ever had and he knew Crohn’s so well. He looked at my hands and said, “Have you ever noticed that your fingernails are shaped like the back of a spoon?” He called this clubbing.

Surgery, and an Answer at Last

Eventually, the only way to definitely learn what was going on was to do exploratory surgery. In August 2004, they found exactly where my Crohn’s damage was located. It was just above the ileum, so too far in to be seen on a colonoscopy and too far down to be picked up by an endoscopy. Apparently, this had been developing for so long that inflammation had destroyed a whole section of my small intestine.

I was relieved to get a diagnosis. The big thing you want when you go through all of this is to have an answer for your symptoms and a plan. When I woke up after the surgery, they said, “You definitely have Crohn’s disease. It’s a permanent, chronic illness.” They did a resection of my intestine while I was in surgery, and they thought that hopefully, my disease would stay in remission with medications. It did for 6 years. Then, it came back with a vengeance in 2010. I had flaring, active disease again in my large intestine.

Play the Cards You’re Dealt

Crohn’s can appear anywhere in your digestive tract from your mouth to your large intestine. Colitis is only in your colon. The unfortunate thing about Crohn’s is that no amount of resecting can cover it. It was at that point when I realized the unfortunate cards I had been dealt. I realized that it would always be difficult for me to keep my Crohn’s under control.

Between 2004 and 2014, I was on seven different medications. At first, I only had to take an anti-inflammatory and an immunomodulator [drugs that treat the immune system to control Crohn’s flares]. That worked for 6 years. When I flared again, they put me on high doses of prednisone, a steroid: short bursts, but often. Then, I switched to biologics when nothing else would work. They worked longer, and initially, they were more effective. I have taken literally everything.

Reach Out for Help

What did I wish I knew when I was younger? I definitely wish I had known there were resources available to help us understand Crohn’s and what I was going through. Obviously, the Crohn’s & Colitis Foundation of America (CCFA) does all it can to get information out there for patients. My family and I had no idea what this disease was or where to go for help. We never knew anyone else who had Crohn’s. We found out later that a cousin on my dad’s side had Crohn’s, too, but nobody else in my family had it.

Another thing I wish I knew was that, maybe for far too long, we thought the right doctor to see for my symptoms was my pediatrician. I really needed to see a gastroenterologist, because they specifically treat the GI system. Some of these doctors specialize in inflammatory bowel disease (IBD). I wish I had known that you could see someone who was also involved in Crohn’s or IBD research. They could have told us about clinical trials of new treatments that are not available to the general public yet but could be available for you if you have Crohn’s. These are medicines that can save lives.

I wish I had known that there were other resources to help people with Crohn’s. It was a very big issue for me that I was missing so much school. My school didn’t understand why I was missing classes. My dad had to go to get doctor’s records and letters to prove that I was out of school for legitimate medical reasons.

25 Bathroom Trips a Day

By 2010, I kept trying different biologics. I was learning to do home injections. I kept telling myself, “Well, it’s better than the alternative! Better than experiencing all of my symptoms.” Eventually, those drugs weren’t working either. I was going to the hospital more and more for vomiting, pain, and incontinence. These were signs that something was amiss. I had loose, bloody stool. I was running to the bathroom 25 times a day. I could not even finish a meal without running to the bathroom.

In 2014, I made the decision to do a diverting ileostomy [surgery to steer waste to a pouch instead of the inflamed gut]. They thought that giving my colon some bowel rest would help. I did that for a year, and I didn’t get better. My disease was severe. So, in 2015, I had permanent ileostomy surgery. They removed my large intestine and what’s called “the stump,” which is basically the anus. I don’t have a large bowel anymore. All stool comes through my small intestine to an ileostomy bag.

Thankfully, I worked for 9 years at CCFA. They were very understanding about patients working for them and had good insurance. I had to take short-term disability and max out my FMLA [Family Medical and Leave Act] leave. They were able to work with me, and I was able to keep my job. Recently, I was laid off due to the pandemic, and I now work at Habitat for Humanity.

Don’t Overlook Your Mental Health

On the first day of my current job, I had so much scar tissue built up that I had a severe vomiting episode. On my first day! I had to have surgery to remove scar tissue. Thankfully, with this job, I was open and honest with my boss about my Crohn’s disease. She was able to give me leave time in advance so I could get better. I love my job.

If I could give advice to someone who is first diagnosed with Crohn’s, it would be this: Have a support system, whether that’s your parents, a friend, or someone else. You will need people who can drive you to the hospital or for tests.

Crohn’s can be mentally taxing as much as physically taxing. Don’t underestimate your mental health needs. Get help or medication if you need it. I learned this the hard way. When I had surgery, they prescribed pain medication, which you need at first. But these drugs can cause depression, too. You don’t feel the physical pain for a while, but when you come off those drugs, you can feel so low. Trying to avoid that situation whenever possible helped me. I also take an antidepressant. Talk about all of your options with your doctor. Over-the-counter probiotic supplements also helped me, and I wish I had known this earlier.

One thing I’ve learned is that you must look at the whole body when you’re treated for an autoimmune condition like Crohn’s. My condition is more systemic. I have become very interested in the connection between the brain and the gut. They’re clearly connected.

Stress can affect your gut health. My Crohn’s flares happened to me during stressful times in my life, such as when I was graduating from high school and college and planning my wedding. Don’t overlook your mental health.

[ad_2]

Source link

October 20, 2022
Should You Stay or Go? When to Change Treatments

[ad_1]

Treating psoriatic arthritis (PsA) isn’t like treating strep throat. You don’t just take one medicine for a few days and feel better. PsA is a complex, chronic disease that stays with you and affects many parts of your body — skin, joints, nails, heart, and lungs.

Many medications slow PsA and relieve symptoms, but the first treatment you try won’t always be the right one for you.

“There is no one-size-fits-all, and there is no one medication for psoriatic arthritis,” says Saakshi Khattri, MD, assistant professor of dermatology and rheumatology at the Icahn School of Medicine at Mount Sinai in New York. “So often there are patients who do not respond to their medication.”

There are a couple of reasons you might need to switch to a new treatment, says Ethan Craig, MD, assistant professor of clinical medicine at the University of Pennsylvania and rheumatologist at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia.

“One is intolerance — the patient has a side effect of some sort. The second is ineffectiveness. Either the medication doesn’t work in the first place, or it works for a period of time and then it stops working,” he says.

When your medicine doesn’t tame your symptoms, it’s time to regroup with your rheumatologist or dermatologist and talk about other treatment options.

Signs That It’s Time to Change

The clearest signs that you need a medication switch is a new flare-up of symptoms.

Worsening joint pain and stiffness, increased fatigue, and sudden trouble doing activities that were easy for you are some of the most obvious symptoms. More subtle signs like difficulty sleeping and mood changes also suggest the medication you’re on isn’t controlling your PsA well enough.

If you’ve just started on a treatment, you do need to give it time.

Sometimes you can have a partial response — maybe the swelling comes down in some of your joints but not in others. Then your doctor might suggest that you wait it out for 4 to 6 months to give the drug more time to work. During that time, steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) can help bridge the gap until your medication kicks in.

Once you’ve been on a treatment for several months with no improvement, or if you’re no longer getting relief from a drug you’ve been taking for a while, “that’s often an indication that we need to think about switching things up,” Craig says.

Advice for Switching Meds

PsA treatment comes in many forms. Often anti-inflammatories and conventional disease modifying drugs are used (DMARDS). Biologic DMARDS are also often used; they target different pathways in the immune system. There are other options for treatment as well, including targeted synthetic DMARDS and newer oral agents.

Your doctor will take a few factors into consideration when recommending your next step, including:

Your symptoms. PsA causes a variety of symptoms. Your choice of medication may hinge on the type of symptoms you have, how much they bother you, and which drug targets them best.

For example, one of Craig’s patients worked at a ticket window. “Because he had to hand out tickets, he was very self-conscious about the appearance of his nails,” Craig says. “He was willing to be on a drug that helped his nails, even if it didn’t help his arthritis.”

The drug’s side effects. Each type of medication comes with a set of side effects, which you need to balance against its benefits. For example, methotrexate can irritate your stomach, while biologics increase the risk for infections. It’s important to think about which side effects you can tolerate and which ones you definitely don’t want.

How you take the drug. Many PsA meds come as an infusion or an injection. If you’re not a fan of needles, you might prefer a pill.

What other conditions you have. Methotrexate can damage your liver. NSAIDs are linked to heart problems. So if you already have liver or heart disease, these medications may not be safe for you.

Your insurance coverage. Ultimately, your insurance company could decide which treatment you get next. “The sad fact of the matter is that our choice of medication is often substantially constrained by insurance approval,” Craig says.

Some insurance companies will expect you to try a certain drug first and prove it doesn’t work before they’ll let you switch to the medication that you and your doctor want to use.

How to Ask Your Doctor for a New Treatment

You might already see your doctor every 3 to 4 months if you take medication. During those visits, the doctor can examine your joints, do imaging tests, and check your lab test results to see whether your PsA is under good control.

But tests don’t always tell the whole story. Your point of view is important, too. Let the doctor know if you’re having any problems with your medications, including side effects or breakthrough symptoms.

If you’re not due for a visit yet, call the office or send your doctor an email about your concerns through the patient portal.

Don’t be afraid to speak up. “A lot of patients are hesitant. They don’t want to take up the doctor’s time,” Craig says. “It’s helpful for us if they come in. I hate to see someone suffer for months. And it’s often easier to intervene earlier in the course of the disease, when things are less active.”

If your doctor isn’t on board with you switching medications, don’t be afraid to push back to get on the right treatment. “Sometimes it’s a matter of miscommunication,” he adds. “We need to be on the same page as to what the expectations are, what we’re treating, and what effect we expect.”

[ad_2]

Source link

October 17, 2022
Lowering the Expense of Psoriatic Disease Treatments

[ad_1]

By Steve Feldman, MD, as told to Kendall Morgan

For the last 29 years, I’ve specialized in treating patients with psoriatic disease, a chronic immune condition that includes psoriasis. I’ve been involved in studies where new drugs are being tested and in the development of new treatment guidelines. There were changes and new developments in treatment right from the beginning. There’ve been various topical treatment options, oral drugs, and then, more recently, the development of biologic treatments.

Biologics have revolutionized the management of moderate to severe psoriasis and other psoriatic conditions including psoriatic arthritis, but they also can cost tens of thousands of dollars per year. I’ve done a lot of research into these costs, and what I came to realize is that it’s hard to know how much any particular patient actually will pay for a particular drug. That’s because of contracts with insurers and other programs. So, keep in mind that the retail price of a drug isn’t an accurate reflection of how much you (or your insurer) will pay.

Still, these costs can be intimidating. I’ve had patients who lost their insurance not come to see me because they felt they couldn’t afford it. But there are lots of ways to get to low-cost or even free medications for those who can’t afford it otherwise. Health insurers often will specify which drugs they’re willing to pay for. If you don’t have insurance coverage, you might actually have more treatment options, not fewer. Many drug companies offer financial assistance through special support programs. You can look into financial assistance through nonprofit or government organizations, too. There may be a process involved, but you should never assume that treatment is out of reach simply based on your income or insurance status. Even if you think your household income is too high, you still might qualify for financial assistance or price breaks. It never hurts to ask.

If your symptoms are mild, you can save on costs even before you go to see a doctor. For mild psoriasis on the face or other sensitive parts of the body, for example, you can try over-the-counter treatments such as hydrocortisone ointment. It’s a relatively weak topical, but it may be strong enough. Topical tars can be messy and smelly, but they also can be effective if you’ll use them. Scalp psoriasis is common, and over-the-counter medicated shampoos can be useful there. Also, getting sun on psoriasis is a good way of treating it. We do phototherapy in the office, and that’s costly. But just spending time in the sun can make your psoriasis symptoms better.

When you go to the doctor, finding one who takes your insurance will keep your copays lower. If the doctor prescribes medications, I recommend going to GoodRx.com to see what the medicines cost at different pharmacies and what breaks are available. Even generics can be expensive, so it’s always a good idea to check and compare prices first. Sometimes there can be vast differences between pharmacies. Check if the medication is one that your insurer will cover.

If your doctor recommends phototherapy (also called ultraviolet light) treatments, these can cost a lot less than many of the biologic medications used for severe psoriasis. But, depending on your insurance coverage, it may actually cost you more in copays. As an alternative, see if you can find a tanning bed at a gym or somewhere else in your community. Oftentimes it’s possible to get unlimited access for a low monthly fee. It’s a good idea to talk with your doctor about any treatment you use, but home phototherapy, sunlight, and tanning beds can be reasonable ways of reducing costs even if your psoriasis is severe.

Another thing patients with psoriatic disease can do if they are doing well on a drug taken every 2 weeks is to try taking it every 3 or 4 weeks instead and see what happens. It might work to stretch the dosing this way, and that can lower the cost. However, if your prescription copay is low anyway, this may not affect your cost all that much. It’s best to let your doctor know if you are adjusting your medications and spreading the doses out this way, as it could make it more likely the treatment will stop working over time. This said, there are now lots of treatment options, so I don’t worry about this as much as I used to.

Keep in mind that you will need to see a specialist to get these prescription medications. Your primary care doctor most likely won’t have access to biologics. When you choose a specialist, make sure they have experience treating psoriatic disease and let them know about any financial concerns you have. I give patients my phone number and tell them that if they get to the pharmacy and the drug costs a lot, they can call me and see if there’s an alternative treatment or a financial assistance program available to lower the cost. I’ve seen too many patients who blindly filled a high-cost prescription when there was a way to pay less. I’ve also seen too many patients suffer by delaying needed treatment.

This doesn’t need to happen. There are many steps you can take, and help is available to lower your costs while ensuring that you get the treatment and care you need.

[ad_2]

Source link

October 10, 2022