A latest drug for treating a style of inflammatory bowel disease (IBD) has been given the go-ahead by the Food and Drug Administration.
On Friday, the FDA approved Pfizer’s etrasimod, branded as Velsipity, for treating adults with the chronic digestive disorder often called ulcerative colitis (UC).
The oral, once-daily pill was granted approval after a clinical trial showed a discount in disease symptoms for patients who took the drug compared with those that took a placebo.
“There’s a lot of therapies” now available for ulcerative colitis, Dr. Arun Swaminath, director of the IBD program at Lenox Hill Hospital, told The Post.
“We’re seeing pretty amazing results” with the newer drugs, Swaminath added. “I feel for those who look over the previous few years, it’s been game-changing.”
Velsipity vs. Zeposia
For UC, the one comparable drug in Velsipity’s class of S1P receptor modulators is Zeposia (ozanimod), made by competitor Bristol Myers Squibb.
Velsipity helped 27% of patients achieve remission of ulcerative colitis symptoms after 12 weeks on the drug, versus about 7% for those taking a placebo.
And the difference in remission rates after one 12 months was increased by 25%, based on Fierce Pharma. By comparison, Zeposia showed a 19% advantage over placebo after one 12 months in its clinical trial.
As a pill, Velsipity could have a further advantage over other drugs for UC like so-called biologic treatments which might be given by injection, since many individuals — including health care employees — have a fear of needles.
“Due to the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time. Patients may be apprehensive about using injectable therapies, like biologics,” Dr. Michael Chiorean, co-director of the IBD Center at Swedish Medical Center, said in a news release.
“It’s vital to have latest, effective options like Velsipity for those patients who may require a complicated treatment option and like the convenience of a once-daily pill,” Chiorean added.
What’s ulcerative colitis?
Ulcerative colitis is an IBD that causes inflammation and ulcers (open sores) within the innermost lining of your large intestine (the colon) and the rectum, based on the Mayo Clinic.
(One other common style of IBD is often called Crohn’s disease, which may involve different areas of the digestive tract in several people, mostly the small intestine.)
In 2023, the worldwide prevalence of ulcerative colitis was estimated to be about 5 million cases, and the incidence is increasing worldwide, based on the medical journal The Lancet.
Symptoms of ulcerative colitis
Symptoms of UC may include:
- Diarrhea, often with blood or pus
- Rectal bleeding
- Abdominal pain and cramping
- Rectal pain
- Urgency to defecate, or an inability to defecate despite urgency
- Weight reduction
- Fatigue
- Fever
- In children, a failure to grow normally
Symptoms of UC can go into remission for lengthy periods of time. The causes of the disorder aren’t well understood, but it surely’s believed that the immune system could also be functioning improperly, causing it to attack the cells within the digestive tract.
It can also run in families, and a few studies show it could possibly be more common amongst people of Ashkenazi Jewish descent.
“There’s a variety for the way serious it could possibly be,” Swaminath said. Some people experience lengthy periods of asymptomatic remission, “then there are people who find themselves so sick that they’re hospitalized for it.”
Ulcerative colitis treatment
The range of medicines for UC includes anti-inflammatory drugs similar to corticosteroids, immune system suppressors and biologics that focus on proteins made by the immune system. In severe cases, surgery may be a treatment option.
“There’s an explosion of options for patients,” Swaminath said, “especially for patients who’ve a tough time with injections or infusions.”
“Matching the precise treatment to the precise patient” is the goal, he added, since latest therapies allow patients to guide a full life without enthusiastic about their IBD. “Their colonoscopies either look improved or back to normal. That’s the endpoint that patients ought to be on the lookout for.”
“UC can affect patients otherwise and lots of people living with this disease struggle with ongoing symptoms,” said Michael Osso, President and CEO of the Crohn’s & Colitis Foundation.
“The introduction of a latest treatment for UC could increase options for patients, and we look ahead to seeing the impact of Velsipity for patients across the US,” he added.
