Fact checked by Nick Blackmer
The FDA approved Velsipity (etrasimod), a drug by Pfizer to treat ulcerative colitis.
The daily oral pill can reduce inflammation in the gut and help patients reach remission.
The approval adds another treatment option for patients who respond poorly to, and prefer not to take, an injectable biologic drug or steroid.
The Food and Drug Administration (FDA) recently approved a new, steroid-free oral medication to treat adults with moderate to severe ulcerative colitis, a type of inflammatory bowel disease (IBD).
The drug, called Velsipity (etrasimod) and created by Pfizer, belongs to a class of small molecule therapies that target the inflammatory responses that spur ulcerative colitis. While many of the existing treatments for the condition require an injection, Velsipity comes as a pill to be taken once daily.
“Ulcerative colitis is a difficult disease to treat. It’s a chronic illness that has no cure, and we need multiple therapies to be able to tackle this,” said Randy Longman, MD, PhD, an ulcerative colitis and Crohn’s disease expert and director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine.
For those who are not ready for biologic drugs like Humira (adalimumab), which are given as injections or infusions, Velsipity can be a great treatment option, Longman added.
Ulcerative colitis is a condition that causes bloody stool, abdominal pain, and frequent urges to poop. It affects about 1.25 million people in the United States. The disease may flare up and subside throughout a person’s lifetime, so most people need to manage the disease for years.
How Velsipity Works
Velsipity is a selective sphingosine-1-phosphate (S1P) receptor modulator—a new class of drugs that have gained attention for their potential to treat IBD.
S1Ps work by blocking certain immune cells from leaving the lymph nodes and traveling to the stomach and intestines, where they can cause inflammation.
Velsipity is the second S1P modulator to gain FDA approval for treating ulcerative colitis. The first one, called Zeposia (ozanimod), was approved in 2021 to treat ulcerative colitis and relapsing forms of multiple sclerosis in adults.
Related: How Ulcerative Colitis Is Treated
Efficacy and Safety of Velsipity
A phase 3 trial tested the efficacy of a once-daily 2-milligram dose of Velsipity in patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Two-thirds of the participants had never taken a biologic or JAK inhibitor drug.
After three months, 27% of patients on Velsipity went into clinical remission, compared to about 7% taking the placebo. After a year, the results were the same in the placebo group and increased to 32% in remission in the treatment group.
Another three-month clinical trial yielded similar results to the first trial. Endoscopy showed that people taking the drug had less severe disease and higher mucosal healing, defined as the disappearance of ulcers and other lesions.
Most of the side effects from Velsipity were mild, including headache, elevated liver tests, and worsening of ulcerative colitis. Because Velsipity is an anti-inflammatory medication, it can also hinder the immune system. Pfizer said patients may be more susceptible to infections in the five weeks after starting Velsipity.
Longman noted that while the study showed that the drug works well for some people, the results were “lukewarm.” There wasn’t a massive difference in outcomes between the treatment and placebo groups.
Still, he emphasized that Velsipity will be “very helpful” for some patients and that its approval gives providers another much-needed option for treating a notoriously difficult disease. Besides, as more data on Velsipity is published, providers may better understand how it can be used in combination with other therapies for improved outcomes.
“I have multiple patients who failed numerous other conventional and biologic therapies that are now on stable dosing of S1P modulators for multiple years now,” Longman said. “The important thing is to figure out for which patients this is the right therapy.”
How Velsipity Fits Into Other Ulcerative Colitis Treatments
Most of the current treatment options for moderate to severe ulcerative colitis work by tamping down the immune system to ease inflammation in the gastrointestinal tract. Providers often combine multiple therapies to best address a patient’s individual needs.
In addition to SLP-1 modulators, patients may take the Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) for an advanced oral therapy. If they don't respond well to anti-inflammatory drugs, they could switch to biologics such as Humira and Entyvio (vedolizumab).
Common medications for ulcerative colitis come with some serious side effects, so patients taking them should regularly check in with a provider.
“People living with the disease can cycle through several different treatments over time. Patients may also be apprehensive about using injectable therapies, like biologics,” said Michael Chiorean, MD, co-director of the IBD Center at Swedish Medical Center and an investigator in the Velsipity trials. “It’s important to have new, effective options like Velsipity for those patients who may require an advanced treatment option and prefer the convenience of a once-daily pill.”
There are non-medication treatments and practices that can help quell ulcerative colitis. Some people who don’t respond to medications may choose to undergo surgery to remove the colon.
Lifestyle modifications can also help. These include avoiding foods that contain large amounts of dairy and fiber, getting adequate exercise and sleep, and minimizing stress to help reduce flare-ups.
Read Next: What to Eat When You Have Ulcerative Colitis
What This Means For You
There is currently no treatment to cure ulcerative colitis, but a combination of medications and lifestyle changes could help make this condition more manageable.
Read the original article on Verywell Health.