FDA Approves Skyrizi for Ulcerative Colitis
Illustration by Zoe Hansen for Verywell Health
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Key Takeaways
The FDA has approved Skyrizi, a drug already used to address psoriasis and Crohn’s disease, for the treatment of ulcerative colitis.
Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine, resulting in symptoms like increased stool frequency, diarrhea, and abdominal pain.
Skyrizi works by blocking the immune system protein interleukin-23 (IL-23), which is one of the key proteins for causing inflammation.
The Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) to treat moderate to severe ulcerative colitis in adults. This approval expands upon Skyrizi’s previous approvals for other inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers on the inner lining of the large intestine, resulting in symptoms like diarrhea, abdominal pain, and increased stool frequency. It affects approximately 600,000 to 900,000 people in the U.S. between the ages of 15 to 30; however, the disease may develop at any age.
Clinical trials conducted by AbbVie, the drugmaker, showed that around 20% of people with moderate to severe ulcerative colitis achieved clinical remission after 12 weeks of starting Skyrizi infusions. For those who continued with Skyrizi injections for 52 weeks after responding to the infusions, remission rates increased to 40%.
This approval is especially beneficial for patients who have already tried other treatment options, such as anti-inflammatory medications or corticosteroids, without much success, Edward V. Loftus, Jr., MD, Maxine and Jack Zarrow Family Professor of Gastroenterology at Mayo Clinic, told Verywell. He said that the results of a phase 3 study showed Skyrizi worked both in patients who had failed conventional and advanced therapies.
Related: How Ulcerative Colitis Is Treated
How Is Skyrizi Different From Other Ulcerative Colitis Treatments?
Skyrizi stands out as a distinct treatment for ulcerative colitis due to its targeted approach to inflammation, Rudolph Bedford, MD, board-certified gastroenterologist at Providence Saint John’s Health Center in Santa Monica, CA, told Verywell. It’s an interleukin-23 (IL-23) inhibitor, meaning it blocks IL-23, a key protein responsible for causing inflammation.
“It blocks the IL-23 receptor that is activated in patients who have Crohn’s disease or ulcerative colitis, therefore preventing the immunologic action from taking place that causes inflammation of the bowel wall,” he said.
Unlike some traditional ulcerative colitis therapies like tumor necrosis factor (TNF) blockers, Skyrizi is less likely to cause severe side effects.
“With some of the older biologics, there were a lot of black box warnings about serious infections or increasing the risk of skin cancer or lymphoma,” Loftus Jr. said. “This medication doesn’t have those kinds of warnings.”
Bedford added that some treatments like Stelara (ustekinumab) and Omvoh (mirikizumab) work similarly to Skyrizi by targeting IL-23. However, they’re considered less effective, possibly because they don’t fully block or regulate the IL-23 pathway as efficiently as Skyrizi does. This could be due to differences in how they work, their dosage, or their specific interaction with IL-23 receptors.
“I believe [Skyrizi] is better than existing options. Patients appear to have relief of symptoms sooner and essentially normalization of the colon lining,” Bedford said. “I’ve treated patients with Skyrizi, and every single one of them has done amazingly.”
Who May Not Be a Good Candidate for Skyrizi?
Those with an active infection or who are susceptible to infections may not be suitable candidates for Skyrizi, Bedford said.
In addition, those with certain medication conditions should also discuss with their healthcare provider before using Skyrizi, including those who have tuberculosis or have been in close contact with someone with tuberculosis, are pregnant, or plan to become pregnant, or have recently received a vaccine.
What This Means For You
If you have ulcerative colitis or continue to experience symptoms despite current treatments, you could consult with a gastroenterologist to discuss whether Skyrizi is right for you.
Read the original article on Verywell Health.
