Your Top Questions About Biologics and Crohn's Answered
Of the many available treatments for Crohn's disease, perhaps the most interesting are the biologics—because unlike most medications, they’re made from antibodies, genetically engineered from living organisms in a lab.
You might have heard of natural antibodies—they're our frontline soldiers, produced in our immune system to combat invaders like chemicals, bacteria, and viruses, otherwise known as antigens. Sometimes we produce antibodies when our immune system incorrectly identifies healthy tissue as an antigen, resulting in an autoimmune disorder. While Crohn's disease doesn’t meet standard criteria as an autoimmune disorder, it is a chronic inflammatory disorder, or inflammatory bowel disease (IBD). Biologics work to stop that inflammatory response. Here's what you need to know about them.
Why Use Biologics for Crohn's?
Biologics bind to specific inflammation-producing proteins known to be improperly activated in Crohn's disease. Unlike steroids, which can affect your whole body with side effects, biologics target only one thing: the mechanism driving the disease. Do biologics have the potential for side effects, some serious? Yes. Do biologics suppress your immune system? Yes. But they also only target proteins proven to be involved in IBD.
Which Biologics Are Approved for Crohn’s?
These biologics are currently approved for Crohn’s by the U.S. Food and Drug Administration (FDA):
- Anti-tumor necrosis factor (TNF) agents: Humira (adalimumab), Cimzia (certolizumab pegol), and Remicade (infliximab)
- Integrin-receptor antagonists: Tysabri (natalizumab) and Entyvio (vedolizumab)
- Interleukin-12 and -23 antagonists: Stelara (ustekinumab)
How Are They Administered?
Because biologics are large protein molecules, you can’t take them like traditional chemical-based medications with smaller structures (yet). “These really big proteins don’t cross the stomach or the intestinal lining easily, so you can’t take most of these by mouth. You have to get an infusion (via an IV) or a subcutaneous injection (a shot),” says Adam C. Ehrlich, M.D., the co-medical director of the Inflammatory Bowel Disease Program at Temple University Hospital in Philadelphia. How often you need to get the infusion or shot varies based on the specific drug and your response to it.
How Do You Give Yourself a Shot?
Don’t assume you know how to give yourself one of these injections, advises Elisheva Weiser, R.N., B.S.N., who works with IBD patients at Johns Hopkins Medicine in Baltimore. Thankfully, your doctor or a nurse can help you learn how to give yourself an injection before sending you off on your own. In fact, Janssen Biotech (Stelara) and AbbVie (Humira) offer free nurse-navigator programs where nurse will come to your home and show you how to do it.
Which Drug Will Work Best for You?
Your doctor will consider your age as well as whether you have any other health conditions. For example, you won’t receive an anti-TNF biologic if you’ve had heart failure (they’re contraindicated). And, something to know about people already on biologics: Remicade was the first available on the market for Crohn’s disease, in the late 1990s, so if a patient you know has been on it for years, that could be why.
But other than these factors? A lot isn’t yet known about which biologic might be best for you, according to experts. “We would love some good predictors to say, based on this patient’s genetic makeup, their inflammatory burden, you name it, they’re going to respond better to drug X rather than drug Y. They don’t really exist yet, at least as far as clinical practice,” says Dr. Ehrlich.
What's the Goal of Biologics in Crohn’s Disease?
One word: remission. The first biologic you'll receive is likely the medicine you'll respond to best—but that one might eventually stop working, researchers say. Over time, your body may start to block the drug's effects. So you'll switch to another to maintain remission. That happened to Aaron Blocker, 27, of Jackson, MS, who has Crohn's. He takes Humira now after starting Remicade in 2010. "I am currently in deep remission," he says. "My scopes are clean, inflammatory markers are normal, and I barely have any symptoms."
Biologics work, says Dr. Ehrlich. "I usually tell people it’s 50/50 that they'll get significantly better on any given drug and sometimes it's more, or less," he says.
How Long Will You Stay on Biologics?
With no cure for Crohn's disease, and bowel damage progressing over time, it’s key to keep inflammation at a minimum. Complications of Crohn's such as fistulas and abscesses can be prevented with biologics, but typically only as long as you continue treatment.
Stopping the medication may cause a problematic chain reaction: "The inflammation comes back, patients end up getting scar tissue, and then you get an obstruction, and then you have to have surgery," says Dr. Ehrlich. He tells his patients that they're on the drug "for now," but with new therapies in the pipeline, future treatment options might be possible. "I try to break it down into one to two years at a time, and we're thinking of what we're going to do now," he says.
When Will You Feel Better?
This differs by patient, Dr. Ehrlich says. For patients receiving their first dose of a biologic, they could feel positive effects within two to four weeks. For those receiving ongoing treatment, they're ideally doing well and continuing to do well. "Every patient is a little different, and it also depends on if you get IV versus injection," he says. (Infusions typically work fastest.)
Blocker wants fellow Crohn's patients to be aware that sometimes, it can take months before experiencing a major change in symptoms. His advice? Don’t give up. "It can be hard to think it is going to work immediately and it doesn't. Be patient and be open with your doctor about it."
What Are the Side Effects?
As mentioned, biologics suppress the immune system, leading to an increased risk of infection. Doctors will also check for latent tuberculosis and hepatitis B if you're prescribed an anti-TNF biologic, because the medication can cause the viruses to reactivate.
"I tell patients that they may get a few more colds than usual, and that those colds might last a few days longer, but generally most folks tolerate that very well," Dr. Ehrlich says.
Another potential side effect is an allergic reaction at the injection or infusion site. A small risk of anaphylaxis is being examined in humans after being observed in mice, according to a systemic review of Remicade, published in the Journal of Crohn's and Colitis.
What About Cancer?
In some instances, the use of biologic drugs may increase the risk of certain cancers. Studies have shown an increased risk of developing non-Hodgkin’s lymphoma and skin cancer. However, the risk of getting cancer from biologics treatment is still very small (6.1 cases per 10,000 patient-years, per one review) and should be weighed against the potential benefits. One 2011 Cochrane review found that the cancer risk was barely any higher than the risk in the general population.
How Expensive Are Biologics?
Very. The drug's composition renders it expensive to make. Many insurance companies require preapproval, so check first if this is required, Weiser notes. Your insurance company won't always tell you how much you owe, and if you have deductibles or out-of-pocket expenses, you'll have to meet those before the medication is covered 100%—a tough prospect when Remicade can retail for $6,000 for five vials at your local pharmacy.
"Many infusion centers have an insurance specialist who can give you a breakdown of what is owed per infusion, so check with the center," Weiser says. "There are copay assistance programs through the manufacture websites that patients with commercial insurance can sign up for and pay as little as $5 per infusion."
What Does the Future Hold?
Hopefully, better predictability for which biologic might work best in individual patients. New therapies also might be on the horizon.
"There are some new drugs coming out that have different mechanisms, so for people who do not respond to medicines that are currently available, they might have some new options, and they may have some benefits over the current drugs," says Dr. Ehrlich.
Another possibility? Oral options for biologics. One company is planning for human trials with its oral technology after successful preclinical studies.
"There are new things. It's a very exciting time in Crohn's disease [research]."