Key Takeaways
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, andCrohn’s disease.
Ulcerative colitisis 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.
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.
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 liketumor 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.”
“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 YouIf 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.
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.
7 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.AbbVie.U.S. FDA approves SKYRIZI (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease.National Library of Medicine: DailyMed.Skyrizi—risankizumab-rzaa kit[drug label].National Institute of Diabetes and Digestive and Kidney Diseases.Definition & facts of ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) met primary and key secondary endpoints in 52-week phase 3 maintenance study in ulcerative colitis patients.Skyrizi.What is Skyrizi?Skyrizi.Preparing for treatment.
7 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.AbbVie.U.S. FDA approves SKYRIZI (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease.National Library of Medicine: DailyMed.Skyrizi—risankizumab-rzaa kit[drug label].National Institute of Diabetes and Digestive and Kidney Diseases.Definition & facts of ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) met primary and key secondary endpoints in 52-week phase 3 maintenance study in ulcerative colitis patients.Skyrizi.What is Skyrizi?Skyrizi.Preparing for treatment.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
AbbVie.U.S. FDA approves SKYRIZI (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease.National Library of Medicine: DailyMed.Skyrizi—risankizumab-rzaa kit[drug label].National Institute of Diabetes and Digestive and Kidney Diseases.Definition & facts of ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis.AbbVie.Risankizumab (SKYRIZI) met primary and key secondary endpoints in 52-week phase 3 maintenance study in ulcerative colitis patients.Skyrizi.What is Skyrizi?Skyrizi.Preparing for treatment.
AbbVie.U.S. FDA approves SKYRIZI (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease.
National Library of Medicine: DailyMed.Skyrizi—risankizumab-rzaa kit[drug label].
National Institute of Diabetes and Digestive and Kidney Diseases.Definition & facts of ulcerative colitis.
AbbVie.Risankizumab (SKYRIZI) achieves primary and all secondary endpoints in phase 3 induction study in patients with ulcerative colitis.
AbbVie.Risankizumab (SKYRIZI) met primary and key secondary endpoints in 52-week phase 3 maintenance study in ulcerative colitis patients.
Skyrizi.What is Skyrizi?
Skyrizi.Preparing for treatment.
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