There is ongoing scientific research on treatments for the chronic inflammatory bowel disease ulcerative colitis. The FDA recently approved a new medication.
When you have ulcerative colitis (UC), the goal of treatment is to stop your immune system from attacking the lining of your intestine. This will decrease the inflammation that’s causing your symptoms and put you into remission.
Your doctor can choose from several types of medication to help you reach these goals.
In the past few years, the number of drugs used to treat UC has increased. In 2023, the Food and Drug Administration (FDA) approved a medication to treat moderate to severe UC in adults.
Researchers are studying other new and possibly improved treatments in clinical trials.
A few types of medication are available to help treat UC. Your doctor will help you choose one of these therapies based on:
- whether your disease is mild, moderate, or severe
- which drugs you’ve already taken
- how well you’ve responded to those medications
- your overall health
Aminosalicylates (5-ASA drugs)
This group of drugs, a first-line treatment for UC, contains the ingredient 5-aminosalicylic acid (5-ASA). This category includes:
- mesalamine (Apriso, Asacol HD, Canasa, Pentasa)
- olsalazine (Dipentum), which is available only as a brand-name drug
- balsalazide (Colazal)
- sulfasalazine (Azulfidine)
When you take these drugs by mouth or as an enema, they help bring down inflammation in your intestine. Aminosalicylates work best for mild to moderate UC. This type of medication has been shown to both induce and maintain remission in people with mild or moderate UC.
The American Gastroenterological Association (AGA) strongly recommends that adults with mild to moderate UC choose a standard dose of oral mesalamine, olsalazine, or balsalazide instead of low dose mesalamine or sulfasalazine or no treatment.
A standard dose of mesalamine is 2 to 3 grams (g) per day.
The authors of a recent research review looking at the
Corticosteroids
Corticosteroids suppress your immune system to bring down inflammation. This type of medication is typically used in people who are hospitalized with acute severe UC.
Examples include:
- prednisone (Prednisone Intensol, Rayos)
- prednisolone (Prelone, Millipred)
- methylprednisolone (Medrol)
- budesonide (Uceris)
Your doctor may also prescribe one of these drugs in the short term to calm a symptom flare.
You may take them in a variety of ways:
- by mouth
- as an injection
- by intravenous (IV) infusion
- as a rectal foam
However, it’s generally not a good idea to stay on steroids long term because they can lead to side effects such as:
- high blood sugar
- weight gain
- infections
- bone loss
You can talk with a healthcare professional about these potential issues and the projected timeline of your steroid treatment.
Immunomodulators
Immunomodulators suppress your immune system to prevent it from causing inflammation. They’re typically used in combination with a biologic to treat severe UC.
Your doctor may prescribe one of these medications if your symptoms aren’t responding to aminosalicylates.
Examples of immunomodulators include:
- azathioprine (Azasan, Imuran)
- mercaptopurine (Purixan)
- methotrexate (Otrexup, Trexall, Rasuvo)
Methotrexate can increase the risk of stomach and intestinal problems.
Additionally, according to a 2018 study, methotrexate may not be effective at helping people with UC remain in remission.
In 2020, the AGA considered whether there’s room for immunomodulators in treating UC. A panel of experts recommended that this type of drug be used in combination with biologics to treat moderate to severe UC when aminosalicylates have not worked.
The FDA has not approved immunomodulators for the treatment of UC, but your doctor may still prescribe them off-label.
OFF-LABEL DRUG USEOff-label drug use is when a drug that’s approved by the FDA for one purpose is used for a different purpose that hasn’t yet been approved.
A doctor can still use the drug for that purpose because the FDA regulates the testing and approval of drugs but not how doctors use drugs to treat their patients.
So your doctor can prescribe a drug however they think is best for your care.
Biologics
Biologics are made from genetically engineered proteins or other natural substances. They act on the specific parts of your immune system that drive inflammation.
The authors of a
- Adalimumab: found to be effective in both the short and the long term
- Infliximab: found to induce a short-term response, remission, and mucosal healing
- Golimumab: similar to other biologics but requires more dose monitoring
- Vedolizumab: has higher remission rates than adalimumab and is less expensive
- Ustekinumab: newest drug found to improve remission rates, but needs more research
TNF blockers
Anti-TNF drugs block tumor necrosis factor (TNF), an immune system protein that triggers inflammation. TNF blockers can help people with moderate to severe UC whose symptoms haven’t improved while they were taking other medications.
Examples of TNF blockers include:
Adalimumab and golimumab are given by subcutaneous injection, while infliximab is given by IV infusion.
Vedolizumab (Entyvio)
Vedolizumab (Entyvio) is also used to treat moderate to severe disease. It stops damaging white blood cells from entering your gastrointestinal tract and causing symptoms such as inflammation.
Vedolizumab used to be available only by IV infusion, but the FDA recently approved it for subcutaneous administration.
Choosing a biologic
The AGA suggests that people who have moderate to severe UC and are new to biologics choose infliximab or vedolizumab rather than adalimumab. Infliximab and vedolizumab are more effective.
However, some people may find adalimumab to be more convenient since it can be self-administered. The other biologics must be administered by a healthcare professional.
It’s fine to choose adalimumab if you’d prefer a self-injectable medication or if you otherwise find it more accessible or affordable than the other biologics. You can discuss all of this with your doctor.
If the treatment you’ve tried hasn’t helped manage your symptoms or if it stops working, you might need surgery. There are multiple types of surgery for UC.
Proctocolectomy with ileal pouch-anal anastomosis is the most common type. In this procedure, a surgeon will remove your entire rectum and colon to prevent further inflammation.
After surgery, you won’t have a colon to store waste. Your surgeon will create a pouch inside your body from part of your small intestine (ileum). The internal pouch will collect your waste.
The procedure used to create the internal pouch is known as an ileostomy.
In addition to the internal pouch, you’ll have an external waste bag (ostomy bag) or a catheter. Whether you have an ostomy bag or a catheter is determined by the type of ileostomy you receive.
Surgery is a big step, but it will help relieve the symptoms of UC.
In the last few years, a few new UC medications have emerged.
Mirikizumab (Omvoh)
This drug, an interleukin-23p19 antagonist, was approved by the FDA in 2023 to treat moderate to severe UC in adults.
The first three doses of the medication are given by IV infusion. Then, once every 4 weeks, the drug is given as a subcutaneous injection.
Ustekinumab (Stelara)
The FDA approved the biologic ustekinumab (Stelara) in October 2019. This medication works by targeting two inflammatory proteins, IL-12 and IL-23.
The first dose of ustekinumab is given by IV infusion. Later doses are given by subcutaneous injection.
Biosimilars
Biosimilars are a relatively new class of drugs that are designed to mimic the effects of biologics. Like biologics, these drugs target immune system proteins that contribute to inflammation.
Biosimilars work in the same way as biologics, but they may cost much less. Four letters are added to the end of each drug name to help distinguish the biosimilar drug from the original biologic.
In the last few years, the FDA has approved several biosimilars for UC, which are modeled after Humira or Remicade:
- Adalimumab-adaz (Hyrimoz): approved in October 2018
- Adalimumab-adbm (Cyltezo): approved in August 2017
- Adalimumab-afzb (Abrilada): approved in November 2019
- Adalimumab-atto (Amjevita): approved in September 2016
- Adalimumab-bwwd (Hadlima): approved in July 2019
- Adalimumab-fkjp (Hulio): approved in July 2020
- Infliximab-abda (Renflexis): approved in May 2017
- Infliximab-axxq (Avsola): approved in December 2019
- Infliximab-dyyb (Inflectra): approved in April 2016
The Remicade biosimilars are the only ones currently available for purchase in the United States. The Humira biosimilars aren’t available yet because the patent held by Humira’s manufacturer hasn’t expired.
Tofacitinib (Xeljanz)
Tofacitinib (Xeljanz) belongs to a class of medications known as Janus kinase (JAK) inhibitors. These drugs block the enzyme JAK, which activates cells of your immune system to produce inflammation.
Xeljanz has been FDA-approved since 2012 to treat rheumatoid arthritis and since 2017 to treat psoriatic arthritis. In 2018, the FDA also approved it to treat moderate to severe UC that hasn’t responded to TNF blockers.
This drug is the first long-term oral treatment for moderate to severe UC. Other drugs require an infusion or injection.
Possible side effects of Xeljanz include:
- high cholesterol
- headache
- diarrhea
- colds
- rashes
- shingles
Researchers are constantly searching for better ways to manage UC. Here are a few new treatments under investigation.
Fecal transplant
A fecal transplant, or stool transplant, is an experimental technique that involves placing healthy bacteria from a donor’s stool into the colon of someone with UC. The idea may sound unappealing, but the good bacteria are believed to help heal damage from UC and restore a healthy balance of germs in the gut.
Stem cell therapy
Stem cells are the young cells that grow into all the various cells and tissues in our bodies. They have the potential to heal all kinds of damage if we harness and use them correctly.
In UC, stem cells may change the immune system in a way that helps bring down inflammation and heal damage.
Doctors have a wider range of treatment options for UC than ever before. Even with so many drugs available, some people have trouble finding one that works for them.
Researchers are constantly studying new treatment approaches in clinical trials. Joining one of these studies can give you access to a drug before it’s available to the public. Ask the doctor who treats your UC whether a clinical trial in your area might be a good fit for you.
The outlook for people with UC is much better today, thanks to new drugs that can calm intestinal inflammation. If you’ve tried a drug and it hasn’t helped you, other options are available that may improve your symptoms.
By being persistent and working closely with your doctor, you’ll most likely be able to find a therapy that ultimately works for you.