Treating Crohn’s Disease With Biologics: The Basics
In the world of IBD medication options, biologics are unique. Here’s what you need to know about the risks and benefits.
The list of medications available to treat Crohn's disease, a type of inflammatory bowel disease (IBD), can seem long and complex—and we won’t lie, it certainly can be confusing. But thankfully, it can help to break them down to just a few major categories: aminosalicylates, steroids, immunomodulators, and biologics.
The last of these, biologics, are sometimes looked at as a "last resort" option for when other treatments don’t work for you. But they’re actually a highly effective way to treat moderate to severe Crohn’s. Here’s what you need to know about this medication.
What Are Biologics Anyway?
According to the Crohn's and Colitis Foundation (CCF), biologics are so named because unlike other medications, they’re made out of proteins instead of artificial chemicals. Essentially, these drugs are antibodies made in a laboratory that stop certain proteins in the body from causing inflammation. And, as you probably know, inflammation is the biggest enemy in Crohn's disease.
Studies find biologics highly effective in treating Crohn's by helping patients achieve or maintain remission; for example, one large 2017 review found the biologic drug ustekinumab (Stelara) to be significantly more effective than a placebo even after just six weeks of use.
As of 2019, the biologics that are currently approved for Crohn's treatment include the following, per the CCF:
Anti-tumor necrosis factor (TNF) agents such as Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol)
Anti-integrins such as Entyvio (vedolizumab), which only works in the gut and Tysabri (natalizumab)
Anti-interleukin (IL)-12 and -23 agents such as Stelara (ustekinumab)
Your doctor will work with you to determine which biologic is best for you.
How Do They Work to Heal Crohn’s?
Like other Crohn's medications, the main goal of biologics is to help you get into or maintain remission. The drugs target specific proteins responsible for your Crohn’s-related inflammation and help to reduce your overall Crohn's symptoms—from pain to bloody stools—while healing your intestinal tissues.
The three different categories of biologics listed above all work a little bit differently. For one, anti-TNF agents bind and block a small protein called TNF alpha that promotes inflammation in the intestines and other organs and tissues, according to the CCF—blocking that inflammation is key in reducing Crohn's symptoms and allowing for healing.
Anti-integrins also help block inflammation, but they do it by preventing the cells that cause inflammation from moving out of blood vessels and into tissues by blocking a protein on the surface of those cells, says the CCF. Lastly, anti-interleukins target specific proteins (interleukin-23 and interleukin-12) that also play a role in the inflammation process.
Who Should Try Biologics (and Who Shouldn’t)?
One of the key benefits of taking biologics for the inflammation associated with Crohn's disease is how precisely they can target the sources of that inflammation, says the CCF. For example, compared with something like a steroid, which affects the whole body (whether you want it to or not), a biologic specifically hones in on certain proteins known to be involved in IBD.
Biologics are an option for people whose Crohn's disease is classified as moderate to severe—that basically means you’re experiencing typical Crohn's symptoms like pain and frequent diarrhea, along with more advanced issues like fever, weight loss, and anemia, according to the CCF.
Biologics are also sometimes recommended for Crohn's patients to help reduce the need for surgery in the future, according to Neilanjan Nandi, M.D., a gastroenterologist (GI) and associate professor of gastroenterology and hepatology at Drexel University in Philadelphia. Biologics can be a good choice for Crohn's patients, "particularly those that are deemed high risk for needing surgery. Some risk factors include Crohn's patients who have small bowel Crohn's, upper-GI Crohn's, fistulas, strictures, or other complications," Dr. Nandi says.
It’s also important to keep in mind that going on biologics is a big commitment: Once you start, you’ll likely be on them indefinitely, says Dr. Nandi.
How Do You Take Biologics?
There are two ways you can take a biologic medications: via infusion or injection. Dr. Nandi says the route you take comes down to your personal preference and insurance coverage.
"With the IV, you can go to the infusion center and the nurse does the work. You don't have to worry about placing a needle in your arm or leg," he explains. "Whereas, with the injection, a nurse educator will teach you how to do it, but ultimately, you should be trained to have the confidence to do it yourself."
Brian Greenberg, a Crohn’s patient advocate and IBD social ambassador at HealthCentral, takes Humira via injection to manage his Crohn's disease. Initially, giving himself the shots was tricky. "The dark pink button on top of the pen always scared me. I had problems pushing it," Brian says. "There were two instances when I pushed it down, pulled my hand away, and then watched most of my medicine drip down my leg."
Brian eventually switched to a syringe, which worked better for him. "I had more control and didn't have to push a button knowing pain was coming."
Infusions, on the other hand, can take 30 minutes, one hour, or two hours to infuse. They are given at time intervals, usually every four or eight weeks, depending on the medication, while injections are given under the skin and are usually self-administered every two to four weeks, depending on the medication.
How Do You Know if Your Biologic Is Working (or Not)?
There are three key ways to tell whether an IBD patient is responding to a biologic, says Dr. Nandi:
Clinical remission (your symptoms resolve)
Endoscopic remission (how healthy your intestinal tissue looks on a scope)
Steroid independence (biologics aim to get rid of the need for steroids and their side effects while maintaining health and well-being)
Another way of knowing is Histologic remission. After looking at pathology under a microscope, doctors can tell with inflammation markers, labs such as ESR, CRP and stool based calprotectin if a bilogic is working.
"It's not enough to be doing 'OK' on a biologic. We want you to have clinical remission and endoscopic remission without steroid reliance," says Dr. Nandi. Why the high bar? Well, healthy tissue means reduce symptoms and cancer risk associated with IBD. And the main alternative to biologics is long-term steroid use, which is detrimental to the body.
It's typical for some patients to feel dramatically better on a biologic medication, but still have active disease. "There has to be some kind of objective evidence that the inflammation is improving. If the patient isn't taking steroids, feels great, and we can't find evidence of inflammation via scope or imaging, then we know the biologic is working. This is known as deep remission," says Dr. Nandi.
Some patients see improvement in just a couple of months, but others can take longer. Dr. Nandi says he likes his patients to stay on the biologic for eight to 12 weeks to see if a clinical response occurs.
"Patients can start to feel a difference and relief in symptoms much earlier, but we always want to wait for a clinical response before we decide the next course of action." This could mean staying on the biologic indefinitely if it appears to be working, and if not, trying a different biologic medication.
What Are the Potential Side Effects or Complications?
If your doctor recommends you try biologics for your Crohn’s disease, you’ll have to go through a number of steps before you can actually get the medication. To get started on a biologic like Remicade or Stelara, you must first undergo a tuberculosis (TB) screening and hepatitis B screening — that’s because these medications run a risk of reactivating dormant tuberculosis or hepatitis B, according to Dr. Nandi. For anti-integrin biologics like Entivyo, you do not need these screening tests because they don't hold the same risks.
But for the most part, biologics are a safe medication to take, says Dr. Nandi, especially if it means that you're not taking long-term steroids, which can lead to weight gain, brittle bones, anemia, insomnia, vision problems, and more.
"If you start a biologic early, you can delay or prevent a surgical intervention altogether and prevent the need for steroids," Dr. Nandi says. "There is a fear of biologics, especially when a doctor doesn't spend enough time discussing the biologic and the risks of steroids."
Often the decision on whether to take biologics comes down to weighing the risks and benefits. It’s true: There are some risks that come with taking biologics, just like with any medication. Some of the more common side effects, per the CCF, include headache, fever, chills, hives, and rashes. More rare issues include infection (since your immune system is being suppressed by the drug), arthritis, and a lupus-like reaction. Very, very rarely, there have been reports of lymphoma—but it’s unclear whether the risk is actually higher in people who take biologics compared with the normal population, per a 2011 review.
"When we think about keeping someone on biologics, we're thinking about the risks of not being on the biologic," explains Dr. Nandi. "Patients need to be on the medicine as long as it takes, and staying off biologics once they're started is very rare. There's a risk to stopping some types of biologics, because you could develop antibodies that make you resistant to the beneficial effects of the biologic. This applies particularly to anti-TNF biologics such as Remicade, Humira, Cimzia, or Simponi." If this did happen, you’d likely just be switched to a biologic other than an anti-TNF option.
Are They Usually Covered by Insurance?
After the screenings for TB and hepatitis B come back, you’ll need to sign an authorization of benefits form. This means that the prescribing physician needs your permission to ask your insurance company to cover the biologic they're prescribing. This process involves some paperwork, peer-to-peer meetings, and records to be send to the insurance company. Many insurance plans cover biologics, but it does vary from plan to plan. But once all of that is taken care of (expect it to take up to a month), you can schedule your first appointment for either the infusion center or at-home injection and prepare for your first dose.
A Final Word on Biologics for Crohn’s Disease
Deciding to start on a biologic can be unnerving since they require infusions or self-injections, especially if you haven't had the treatment before—it can feel like a big step up from just taking a pill, for example. Dr. Nandi recommends talking to other patients who take biologic medication to manage their Crohn's disease, along with doing your research.
"While I caution my patients about what they read online, I do want my patients to go online and read as much as possible about the biologic, and then I want them to write down all their questions and ask me about it," Dr. Nandi says. Communication with your gastroenterologist is key when starting a new medication like a biologic. Keep your doc informed of any symptoms you experience, either related to your IBD or potential side effects of the medications. And remember: It is imperative that you do not stop or start any medications on your own.
Overall, while biologics run some risks (as do most drugs), the benefits are vast: They can help you manage your symptoms and hopefully achieve complete IBD remission.
In Brian’s case, he takes his Humira every seven days, and he’s come to know the signs that his body truly needs it.
"My hands swell and get tight, and my body has general aches, and I do experience some fatigue," Brian says. While it's not a miracle drug for Brian, Humira keeps his Crohn's in check and has allowed him to get back to pursuing his passions that Crohn’s once endangered—including training for marathons. "It gives me a lifestyle I can manage now, which is so nice."