Biologics might sound scary—like a weapon or dangerous agent—but they truly aren’t. This fascinating class of medication can help put your ulcerative colitis (UC) in remission when no other drug seems to work.
They do have potential side effects. And they don’t work for everyone—and sometimes, they can stop working for inflammatory bowel disease (IBD) without warning. But these drugs can provide you one (or two or three) more chance(s) at feeling better short of colectomy surgery.
Knowing all you can about them before starting treatment is a wise choice, says Gaby DuFour, 25, who lives in Chicago. Diagnosed with UC in September 2017, Gaby started the biologic Remicade (infliximab) in May 2018, when she was hospitalized for the first of two severe flares that year.
“I recommend being as informed of a patient as you can,” she says. “Don’t be afraid to ask your provider questions and make sure you are your own advocate. It’s your life and your health, and you deserve the very best.”
Want to learn more about biologics for UC? We’ve got answers to 10 of the most common questions.
1. What IS a Biologic?
Well, for one thing, they’re alive. And they’re created out of materials found in life. Unlike most medicines, which are produced by a chemical process, these drugs are produced by a “biological” one instead, hence their name.
“What I usually tell patients is very simple,” says Susie Lee, M.S.N., N.P., a board-certified nurse practitioner at the IBD Center at Cedars-Sinai Medical Center in Los Angeles. “I say, ‘A biologic is an antibody, which is a type of protein, that targets the action of other proteins in your body that cause inflammation.”
After Lee explains the science behind biologics to UC patients, a nurse navigator enters the room and explains their risks and benefits, including possible side effects and complications, such as allergic reactions.
The nurse navigator also assists patients in understanding how to afford the high cost of these complex and expensive drugs, including assistance programs offered by the drug companies themselves.
2. Which Biologics Are Available to Treat UC?
Four biologics are approved for UC by the U.S. Food and Drug Administration (FDA). They are:
These four drugs are divided into two classes of biologics, meaning that they act on different proteins that cause UC inflammation, says Constance A. Pietrzak, M.D., a gastroenterologist at Advocate Medical Group in Chicago.
“Remicade and Humira, TNF-alpha inhibitors, are approved for treatment and maintenance of remission for moderate-to-severe UC that does not respond well to more conventional treatments,” she says. “Entyvio, an integrin-receptor antagonist, can be used to treat moderate-to-severe UC unresponsive to Remicade, immunomodulators, or in those who remain steroid-dependent.”
Simponi is another TNF-alpha inhibitor. It’s approved for those with moderate-to-severe UC who are steroid-dependent or have failure to respond to other UC treatment options.
3. Am I a Candidate for Biologics?
If you’ve been on other drug treatments for UC and they aren’t working, biologics might be your next step.
Some notes: Those with heart conditions should not take TNF-alpha inhibitors, so that rules out three of the four available biologics for UC. If you have a history of tuberculosis or hepatitis B and C viruses, you’ll need to be tested for the active virus, and undergo treatment prior to starting a biologic because the medications can re-activate the diseases, causing severe infection.
Other reasons you shouldn’t, and likely can’t, take these medications: You have active infections, certain neurological disorders (multiple sclerosis or autoimmune neurological disorders), or untreated cancers (lymphoma, malignant melanoma, renal cell carcinoma, and lung cancer), Dr. Pietrzak says.
Patients who are already have a compromised immune system should not take the medication, because biologics suppress immunity even more.
4. How Effective Are Biologics in Treating UC?
Pretty good. About 60% of patients respond to treatment, Dr. Pietrzak says. Conventional therapies have limited success in treating moderate-to-severe UC (20% to 40% of patients with UC don’t respond to them), requiring more advanced treatment and possibly surgery. Even though only four biologics are approved for UC, those medications have made a world of difference for UC patients—and should continue to do so.
“The use of biologics has revolutionized our capabilities in successfully treating UC and achieving mucosal healing,” she says.
5. How Will a Biologic Medication Make Me Feel?
The hope is, symptom- and side effect-free most of the time.
After DuFour receives Remicade, she initially feels tired (her one and only side effect), but then has “a bit more energy the first few days, right after, because my battery has been completely recharged.”
You might respond differently, but the goal is to calm UC flares into remission, easing any UC symptoms you might be experiencing.
6. Are There Side Effects?
Yes, biologics have potential side effects.
They can be divided into common side effects, and more serious side effects. Common ones include headache, nausea, and liver-enzyme elevation. More serious ones can include an immediate or delayed allergic reaction (including anaphylaxis, but that’s rare) or cancer.
About cancer and biologics: Studies have shown an increased risk of developing non-Hodgkin’s lymphoma and skin cancer. But this risk is still very small (6.1 cases per 10,000 patient-years, per one review) and should be weighed against the potential benefits. A Cochrane review found that the cancer risk was barely any higher than the risk in the general population.
7. How Do I Take the Medication?
Because biologics are composed of large proteins, they cannot be taken by mouth. The molecules are just too big to be absorbed the usual way. Instead, you take the medicine by infusion (via an IV) or subcutaneous injection, which is a shot.
Infusions can be done at a hospital infusion center, an outpatient infusion clinic, or at home by a home health nurse. Shots are mainly given at home. Remicade, Simponi, and Entyvio are given by infusion. Humira is given by injection.
For DuFour, the toughest part of receiving Remicade by IV is the tiredness she feels during the infusion. “I get so sleepy,” she says. “It’s like clockwork, once the medication starts going in, I am ready for a nap.
Thankfully the infusion takes about two hours, so I am able to knock out for a bit.”
She has infusions every four weeks, usually on Fridays, at an outpatient infusion clinic.
“I usually like to schedule my infusions out one to two months ahead of time so it’s locked in on the schedule,” she says. “My clinic is really great about making sure I have at least my next infusion scheduled before I leave.”
Her recommendations for first-timers: She brings her laptop or watches TV at the clinic to pass the time, if she doesn’t fall asleep. If you think you might get hungry, brings snacks (though the clinic staff order breakfast or lunch for her, if she needs it). And dress in layers.
“It does get cold sometimes, so I usually have a jacket with me, but they do have pillows and blankets,” she says.
8. I Hate Needles. How Do I Take a Biologic Shot?
If you fear needles, never fear—Humira isn’t a shot like you’re likely thinking, but is instead a “pen” injector with a retracted needle that you don’t see. Think EpiPen (epinephrine). The company that makes Humira, AbbVie, has a patient-assistance program to teach you how to use it. A nurse advocate comes to your house and trains you on how to give yourself an injection.
The pen injector can be used in any part of your body with a little bit of fat, but typically, it’s injected into the leg, thigh, or stomach.
9. How Long Will I Take a Biologic?
For biologics to work, you need to continue to take them on a regular basis, not missing or skipping doses. They need to become part of your life’s routine, Lee says. Because there is no cure for UC and it’s a chronic condition, integrating this treatment into your life will help you sustain and maintain your treatment schedule and, in turn, your remission. Staying on top of your doses also helps reduce the odds that you’ll develop antibodies that negate the effect of the medicine.
“When disease is well-controlled on a regimen, then it is recommended that it be continued,” Dr. Pietrzak says. “Patients who used Remicade, discontinued the medication, and required it again, were found to have diminished response the second time around due to formation of antibodies.
“Recently, the concept of de-escalating therapy, where patients on combination therapy are taken off one of these medications, has been studied, particularly in Crohn’s disease. The key is to monitor various clinical factors and for the patient to remain on at least one of the therapies. Stopping all therapy, despite being clinically in remission, is not advised,” she says.
10. What Else Should I Know About Biologics?
It’s OK to feel depressed or anxious about having to take a medication possibly for the rest of your life—just know that your health care professionals will work with you to integrate biologics fully into your day-to-day living, Lee says.
Dr. Pietrzak emphasizes that biologics are safe and effective.
“It is very important that you work with your doctor when taking these medications and keep them informed of any symptoms you experience, either related to your UC or potential side effects of the medications,” she says.
“Prior to taking these medications, it is encouraged that you have an extensive discussion with your physician regarding any testing that needs to be completed, possible side effects from biologics, and potential risk for side effects. Doing so will put you at great ease with starting biologics and also place you in control of your health.”
DuFour is grateful that biologics are an option for her, and that they have helped put her UC into remission.
“I was, and still am, so focused on healing that I didn’t really think much about the fact that I’ll probably be on Remicade for the rest of my life, but since being on it for the past 15 months I’ve been able to regain my strength and life back,” DuFour says. “So to me, it’s worth it!”
Editors’ note: Erica Sanderson contributed to this story.