Biologics work in slightly different ways with different standards of administration and dosing. Some are approved to treat just one form of IBD, while others are used to treat both Crohn’s disease and ulcerative colitis.
Because biologic drugs temper the immune response, people taking them are prone to certain infections. It’s important, therefore, to take steps to reduce your vulnerability. People with IBD should receive vaccinations, ideally before starting a biologic, although many immunizations can also be given while taking a biologic.
According to 2020 guidelines, a biologic drug should be used first-line for treatment (rather than waiting for other treatments to fail) in people with moderate to severe ulcerative colitis.
There are different types of biologics for IBD: anti-tumor necrosis factor (anti-TNF) drugs, integrin receptor antagonists, and interleukin-12/interleukin-23 antagonists. If you’ve never taken a biologic, your healthcare provider is likely to prescribe an anti-TNF drug first.
Many factors are taken into consideration when choosing the right biologic. This can include the type and severity of your disease, your treatment history, and your insurance coverage, among other factors. Doctors will take all of these factors into consideration when making a recommendation for treatment.
Cimzia
Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker that was approved in 2008 to treat Crohn’s disease. It was approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of rheumatoid arthritis and for psoriatic arthritis and ankylosing spondylitis in 2013.
Cimzia is usually given by injection with a prefilled syringe at home. Cimzia is given with two injections, which are first administered in a loading dose at weeks 0, 2, and 4. After that, the two injections are given every 4 weeks. Another form of Cimzia is a powder that is mixed and then injected at a doctor’s office.
Side effects that occur most commonly with this drug are upper respiratory tract infections (like a cold), viral infections (like the flu), rashes, and urinary tract infections.
Entyvio
Entyvio (vedolizumab), approved by the FDA in May 2014, is a gut-homing α4β7 integrin antagonist. It is thought to work by binding to α4β7 integrin, which prevents the integrin from causing inflammation. Entyvio is approved for use in adults who have Crohn’s disease or ulcerative colitis.
Entyvio is always given by infusion, either in a doctor’s office, at a hospital, or in an infusion center. The loading schedule for Entyvio is 3 infusions at weeks 0, 2, and then 6. After that, infusions are given about every 8 weeks.
Some of the potential side effects include a cold, upper respiratory tract infection (the flu, bronchitis), headache, joint pains, nausea, fever, fatigue, cough, back pain, rash, itching, sinus infection, throat pain, and extremity pain.
Humira
Humira (adalimumab) is another monoclonal antibody and TNF inhibitor that is used to treat people with IBD. It is approved for adults and children over the age of 6 that have ulcerative colitis or Crohn’s disease. Humira was initially approved in 2002 and expanded for use in Crohn’s disease in 2007 and ulcerative colitis in 2012.
Humira can be given at home through an injection. Patients are trained on how to give themselves the injection (or it could be done with help from a family member or friend).
Some people with Humira may have what’s called an injection site reaction, which is swelling, pain, itching or redness at the place where the drug is injected. This can usually be treated at home with ice or antihistamine medications (changing injection sites every week also helps).
Remicade
Remicade (infliximab) was approved in 1998, and was the first biologic therapy approved for use in people with IBD. It could be used to treat Crohn’s disease or ulcerative colitis, and it is also approved for kids as young as 6, in certain circumstances. Remicade is thought to work in people with IBD because it is a monoclonal antibody that inhibits TNF, which is a substance that creates inflammation in the body.
Remicade is given to patients through an IV. This could be done in a doctor’s office, but more often occurs in an infusion center, which are specialized facilities designed to administer medications by IV.
Simponi
Simponi (golimumab) is a TNF inhibitor that’s approved for treating ulcerative colitis. Simponi was approved first in 2009 to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. In 2013 it was approved to treat ulcerative colitis. Ankylosing spondylitis is a condition that can be associated with ulcerative colitis, which means that this medication could be used to treat both disorders.
A newer formulation called Simponi Aria was approved for use in 2019 and differs in part because it is delivered intravenously rather than subcutaneously. Because of this, it requires less frequent dosing than Simponi.
Simponi is given at home, so patients are trained by a healthcare provider on how to inject themselves (either by themselves or with help).
Some of the adverse reactions to Simponi are getting infections that cause illnesses like a cold, symptoms like a sore throat or laryngitis, and viral infections like the flu. Having redness, pain, and itchiness at the injection site, often treated with ice and antihistamines, is another potential adverse reaction.
Skyrizi
Skyrizi (risankizumab-rzaa) is a biologic medication that targets the protein interleukin-23, a type of protein that regulates immune responses. It works by minimizing inflammation in people who have Crohn’s and other immune-mediated diseases. Skyrizi was first approved in 2019 for the treatment of plaque psoriasis, and approved again in January 2022 to treat psoriatic arthritis. In June 2022, the FDA approved Skyrizi for treating adults with moderately to severely active Crohn’s disease who are unresponsive to other treatments.
Skyrizi is given intravenously by a healthcare provider in four week intervals for the first three doses (600-mg infusions). After that, the medication (360-mg dose) can be self-injected at home every other month.
Side effects include a possible increased risk of infections, including tuberculosis. Skyrizi is not recommended for people who are pregnant, have a persistent infection, have liver cirrhosis, or anyone who has recently received a live vaccine.
Stelara
Stelara (ustekinumab) is a fully human monoclonal immunoglobulin antibody. It was first approved in 2008 as a treatment for plaque psoriasis, followed by approval in 2016 to treat Crohn’s disease and in 2019 to treat ulcerative colitis. Stelara works to decrease the inflammation Crohn’s disease causes by targeting interleukin (IL)-12 and IL-23, which are thought to play a role in the development of inflammation in the intestine.
The first dose of Stelara is given by infusion, in an infusion center or a doctor’s office. After that first infusion, Stelara can be taken at home with an injection that’s given every 8 weeks. Patients can give themselves the injection after being trained by a healthcare provider.
Some of the more common side effects seen in people with Crohn’s disease who take Stelara include vomiting (during the first infusion), pain or redness at the injection site, itching, and infections such as a cold, a yeast infection, bronchitis, urinary tract infection, or sinus infection.