FDA Approves Skyrizi (Risankizumab) for Ulcerative Colitis

Key Takeaways

• The FDA has given its okay to the biologic drug Skyrizi (risankizumab) as a treatment for people with moderately to severely active ulcerative colitis.
• The medication works by blocking the immune system protein IL-23, which is responsible for inflammation.
• Skyrizi was already approved for the autoimmune diseases plaque psoriasis, psoriatic arthritis, and Crohn's disease.

The U.S. Food and Drug Administration (FDA) has approved the injected drug Skyrizi (risankizumab) to treat ulcerative colitis, offering a new treatment option for people with this type of inflammatory bowel disease.

The FDA approved Skyrizi for adults with moderately to severely active ulcerative colitis, the medication's developer, AbbVie, said in a statement.

According to AbbVie, clinical trials reviewed by the FDA prior to approval found that initial therapy with Skyrizi infusions helped about 20 percent of patients with moderate to severe ulcerative colitis achieve clinical remission within 12 weeks.

Among patients who responded to these infusions and followed them with 52 weeks of Skyrizi injections, remission rates climbed to about 40 percent.

"Early on, this medication has a very good response rate and at one year, clinical remission is achieved and is quite efficacious," says Joseph Feuerstein, MD , a gastroenterologist and associate professor at Harvard University and the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center in Boston.

"This is similar to many of the other drugs - if not more effective," Dr. Feuerstein says. "This drug should be a long-term effective therapy for ulcerative colitis."

Ulcerative Colitis Can Cause a Range of Symptoms

Ulcerative colitis (UC) is a type of inflammatory bowel disease that involves inflammation in the large intestine, which can cause open sores, or ulcers, that produce blood, pus, and mucus. Common symptoms can include abdominal pain, frequent or blood- or pus-filled diarrhea, weight loss, lack of appetite, nausea, fatigue, fever, and anemia.

Although there's no drug that can cure ulcerative colitis, a variety of medications can reduce symptom flare-ups and help patients achieve and maintain periods of clinical remission. Most drugs for ulcerative colitis - including aminosalicylates, corticosteroids, and injected biologics (a type of medication made from antibodies in a lab) - help treat UC by reducing inflammation in the colon.

What Does Skyrizi Do?

Skyrizi is a biologic belonging to a family of medicines known as interleukin-23 antagonists, or IL-23 drugs. These all work by blocking the immune system protein IL-23, which is responsible for causing inflammation. The FDA has previously approved Skyrizi to treat plaque psoriasis, psoriatic arthritis, and Crohn's disease - which, like ulcerative colitis, are autoimmune diseases .

Ulcerative colitis patients start Skyrizi therapy with 12 weeks of infusions, administered every four weeks by a healthcare provider, AbbVie said in its statement. After that, they can continue maintenance therapy by self-injecting Skyrizi at home.

This combination of infusions followed by injections is similar to the approach used with other IL-23 drugs for ulcerative colitis - Stelara (ustekinumab) and Omvah (mirikizumab) .

Does Skyrizi Have Side Effects? Is It Safe?

Ulcerative colitis patients may experience some serious side effects with Skyrizi, including severe allergic reactions, an increased risk of infections, and liver problems. AbbVie noted in its statement that the most common side effects in ulcerative colitis patients are upper respiratory infections, headache, joint pain, stomach pain, injection site reactions, anemia, fever, back pain, urinary tract infection, and rash.

However, IL-23 drugs like Skyrizi are all extremely safe with very few side effects, and are extremely well tolerated by patients, Feuerstein says.

"Additionally, Skyrizi is a drug that once in the maintenance phase is dosed typically every eight weeks which is convenient - and it is self-injectable which is also quite appealing," Feuerstein adds.

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Sources

1. U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease. P.R. Newswire . Jun 18, 2024.
2. Risankizumab (SKYRIZI®) Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis. AbbVie . March 23, 2023.
3. Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients. AbbVie . June 15, 2023.