The Basics of Biologics: Ulcerative Colitis Edition
Considering a biologic for UC? Here's what you need to know before you start.
After you’re diagnosed with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD), the journey to symptom management and hopefully remission can involve a lot of trial and error. If your UC is moderate to severe, meaning you have four or more bloody bowel movements a day (like that's something you want to count), one of your treatment options will likely include a biologic drug. These medications work differently than traditional meds, and large-scale studies have shown that they can be highly effective in helping people with UC achieve or maintain remission, according to research published in the journal Gut and Liver. Check out the basics below then talk to your doctor about which meds are best for you.
What Are Biologics Anyway?
Biologics are different from most medications in that they’re protein-based therapies rather than artificially prepared chemicals. Essentially, these drugs block certain proteins in the body from causing inflammation and work like antibodies; they're designed to lock onto very specific targets.
As of 2019, the biologics currently approved for UC treatment include the following, according to the Crohn’s and Colitis Foundation (CCF):
Anti-tumor necrosis factor (TNF) agents: Remicade (infliximab), Humira (adalimumab), and Simponi (golimumab)
Anti-integrins: Entyvio (vedolixumab)
Your doctor will help you determine which of the four listed above may be best for you.
Often lumped in with the biologic category is a separate class of treatments known as small molecules (such as the janus-kinase [JAK] inhibitor known as Xeljanz); they suppress the immune response like biologics do, but they aren’t technically biologics.
How Do Biologics Work to Heal UC?
These drugs work by stopping specific proteins in your body from causing inflammation, which is a hallmark issue of UC, according to the CCF. Specifically, they help to heal the damage UC causes to your intestinal tissues and reduce UC symptoms like excessive bowel movements, blood in the stool, and pain.
The two different classes of biologics for UC work slightly differently. For example, biologics that are anti-TNF agents bind and block a small protein called tumor-necrosis factor alpha that promotes inflammation in the intestine and other organs. On the other hand, anti-integrins prevent the cells that cause inflammation from moving out of blood vessels and into tissues, where they can wreak their havoc.
Who Should Try Biologics (and Who Shouldn’t)?
Biologics are recommended to UC patients with moderate to severe disease, often after other treatments have failed, says Neilanjan Nandi, M.D., an associate professor of gastroenterology and hepatology at Drexel University in Philadelphia. Oral steroids are typically tried first, according to the American Academy of Family Physicians (AAFP), but if they don’t have the desired response, biologics are often the next step. People with milder UC are typically first treated with drugs called 5-aminosalicylic acids, including mesalamine, which also help reduce inflammation.
"However, UC patients that have more than four to six daily bowel movements may have too much inflammation for mesalamines to have enough healing effect,” explains Dr. Nandi. “The chronic blood loss can result in iron deficiency or anemia, and the patient's quality of life may likely suffer from chronic fatigue and distress.”
"Quality of life" can mean a lot of things, but in this case, Dr. Nandi says it’s assessed based on clinical symptoms and complications, the impact they're having on the person’s social life, and how dependent they are on steroids. (Long-term steroid use can lead to impaired healing, increased blood pressure, and osteoporosis, according to the CCF. Risk of infections is one of the most important complications which is often worse than biologic medications.
If there's a significant impact, then a doctors will usually recommend trying a biologic.
While these drugs are certainly effective, know that they are a long-term treatment: Starting and stopping is not typically recommended. More on this below.
How Do You Take Biologics?
Biologics are administered as either a self-injection you can do at home or as an infusion at an infusion center. Dr. Nandi says it's all about which mode you're more comfortable with: "Ultimately, with giving yourself a shot, there's more pressure. Typically, we give patients a sample pen, without the drug in it, so that they go through the process of getting mentally prepared (by practicing)." Depending on the medication, you'd need to self-inject every two to eight weeks.
If the idea of sticking yourself with a needle makes you cringe, consider the infusion route: “At the infusion unit, the nurse does the work, which can relieve the anxiety associated with administering your own medicine,” explains Dr. Nandi. Infusions can take 30 minutes, one hour, or two hours, and they are given usually every four or eight weeks.
Gaby DuFour, a UC patient who lives in Chicago, receives Remicade infusions to manage her UC symptoms. "I get my dose more frequently (every four weeks); when they were too spread out, I still experienced symptoms," she says.
She equates her infusions to a phone battery: "Your power level gets low, but you can still text, Instagram, and call until it gets to 0%. Maybe it slows down a bit when it gets under 10%, but nothing too noticeable." Then the infusion charges you back up to 100%.
How Do You Know if Your Biologic Is Working (or Not)?
There are three major ways to evaluate whether a UC patient is responding and doing well on a biologic, says Dr. Nandi:
Clinical remission (your symptoms resolve)
Endoscopic remission (your intestinal tissue looks healthy on a scope)
Steroid independence (as in you don't need them anymore)
"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 reduced symptoms and a lower cancer risk, which is already higher for people 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 eight weeks—others take longer. It just depends on your body and how you react to the specific drug. But once the biologic is working, it's typically administered indefinitely to keep the inflammation under control.
Does that mean you can never stop a biologic once you’ve started? Not exactly, but Dr. Nandi warns against stopping treatment because it can cause the body to develop antibodies to the medication. When that happens, the treatment is no longer effective and flare-ups can occur. "Instances of staying off biologics [after starting] are very rare, and we can't predict who those patients will be," says Dr. Nandi. "Even if a patient is in deep remission (meaning you can't tell they've ever had inflammation), we might back down on the treatment, but we'd never stop administering it completely."
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 trying a different biologic medication or a small-molecule treatment, like Xeljanz.
What Are the Potential Side Effects or Complications?
It's true: There are some risks that come with taking biologics. But the fact of the matter is that all drugs come with some risks, and your GI is only likely to prescribe biologics if they think the positive impact will outweigh any potential side effects.
Before you begin, you'll first be screened for tuberculosis (TB) and hepatitis B. That's because certain biologics can reactivate dormant or latent versions of those infections.
Assuming you're infection-free, it's important to be aware of possible side effects and complications of biologic medications so that you can let your doc know ASAP if you experience any issues, according to CCF. Some more common side effects 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, according to one 2011 review.
Are They Usually Covered by Insurance?
After your TB and hepatitis B screenings come back clear, you must submit a prior authorization form to get coverage. This process involves some paperwork as well as discussions between your doc and your insurance provider. Coverage 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 get started with at-home injections or schedule your first infusion appointment.
A Final Word on Biologics For UC
Remember: It is very important that you work with your doctor when taking any medication for UC and keep them informed of any symptoms you experience, either related to your UC or potential side effects of the medications.
"GIs need to do a better job at having open communication with their patients about biologics and treatment options," Dr. Nandi says. Take the initiative and approach your doctor with your questions and concerns. Connect with other patients who might be using a similar course of treatment to get their perspective.
Overall, UC symptoms improve greatly on biologics for most patients, DuFour included. "I'm usually a bit more energetic the first five days post-infusion," says DuFour. "I don't notice any other negative side effects, and my body has responded really well so far."