NEWS Health News FDA Approves Skyrizi to Treat Crohn’s Disease By Claire Bugos Claire Bugos Twitter Claire Bugos is a New York City-based health and science reporter and writer. Learn about our editorial process Published on June 23, 2022 Fact checked Verywell Health content is rigorously reviewed by a team of qualified and experienced fact checkers. Fact checkers review articles for factual accuracy, relevance, and timeliness. We rely on the most current and reputable sources, which are cited in the text and listed at the bottom of each article. Content is fact checked after it has been edited and before publication. Learn more. by Heather Mercer Fact checked by Heather Mercer Heather Mercer is native to Northwest Ohio (go Walleye!) and graduated from Loma Linda University with two doctorate degrees (psychology and public health). She is currently a professor at Owens Community College, as well as a fact-checker for Verywell Health. She has gained experience in a variety of settings, ranging from corporate wellness and preventive medicine, to mental health, chronic disease, and end-of-life care. Learn about our editorial process Share Tweet Email Print Verywell Health / Lara Antal Key Takeaways A psoriasis drug by AbbVie is considered safe and effective for treating people who experience moderately to severely active Crohn’s disease.Many patients treated with Skyrizi in clinical trials saw healing of their gut tissue and a reduction of symptoms.The drug may be effective for Crohn’s patients who are unresponsive to other treatments. The Food and Drug Administration (FDA) last week approved Skyrizi (risankizumab-rzaa) to treat Crohn’s disease, a type of inflammatory bowel disease (IBD). The drug, made by AbbVie, was already approved for treating psoriasis. Now, health providers may prescribe it for adults with moderately to severely active Crohn’s disease. Skyrizi uses a unique mechanism that may alleviate symptoms such as diarrhea and abdominal pain, even in patients who don’t respond well to other treatments. Learn How Crohn's Disease Can Affect Your Digestive Tract It is given intravenously by a health provider for the first three doses. After that, the patient self-injects the medicine every other month. Skyrizi is the first interleukin-23 inhibitor licensed for Crohn's—an approach that has long seemed promising for tamping autoimmune disorders. It is the first treatment licensed for Crohn’s disease in six years, according to AbbVie. “We're very excited to have another modality in our arsenal to tackle [Crohn’s] and to tackle it more selectively,” 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, told Verywell. “It's really a huge win for patients with IBD and gives another medication option, particularly for patients who are refractory.” The Road to Approval Crohn’s disease is a chronic inflammatory bowel syndrome that causes persistent diarrhea and abdominal pain. It is a progressive disease, which means that a case may get worse over time, often leading to surgery. Current treatments are designed to tamp down the immune system’s inflammatory response in the gastrointestinal tract to help alleviate symptoms. Skyrizi is a biologic drug that inhibits certain proteins that help regulate the body’s immune system. The FDA first approved Skyrizi for plaque psoriasis in 2019 and added an indication for active psoriatic arthritis in January 2022. How Skyrizi Works Skyrizi works by blocking interleukin-23 (IL-23), a type of protein that regulates immune responses. Skyrizi targets IL-23, minimizing inflammation in people who have Crohn’s and other immune-mediated diseases. The clinical trials enrolled people with Crohn’s disease who did not respond well to conventional or other biologic therapies. In patients who received the drug, researchers tested their daily stool frequency, abdominal pain score, and improvement in tissue inflammation after a colonoscopy. In the first set of clinical trials, AbbVie tested two doses of risankizumab—1,200 milligrams and 600 milligrams. The company landed on the latter, saying the larger dose did not improve patients’ outcomes. Across the studies, more than 60% who received the 600-mg dose saw symptoms improve, and 42% of patients experienced clinical remission, meaning their symptoms mostly diminished. By comparison, about one in four patients who received the placebo had clinical remission. Clinical Remission Is Not the Main Goal in IBD Treatment Most notably, when researchers performed endoscopies on the patients, they saw healing in gut tissue among 29% of patients in one study and 40% of those in another. Many of these patients had a response to the drug as soon as the fourth week. Next, the company followed patients who had responded well to Skyrizi in the earlier clinical trial for a year. Some patients continued taking the drug in 180-mg and 360-mg doses, while others went through withdrawal. The researchers found that about half of those who continued to use the drug at the larger dose experienced clinical remission and nearly half saw tissue healing. The FDA is currently reviewing data for 180-mg self-administered maintenance doses. What Age Do Most People Get Crohn's Disease? What to Know About Skyrizi The first three doses of Skyrizi are given by intravenous infusion in four week intervals. Health providers administer the 600-mg infusions over at least one hour Patients then self-administer a 360-mg dose with a subcutaneous injection or an on-body injector on the 12th week, and every eight weeks thereafter. There is currently no cure for Crohn’s disease, though there are several medications that can decrease immune system activity and reduce symptoms. Biologic therapies, including Skyrizi, can help people achieve remission if other medicines don’t work. Many Crohn’s patients will seek surgery to treat damage from the disease during their lifetime. Longman said that if Skyrizi proves effective in patients who don’t respond well to other treatments, it could minimize the number of people who require surgery. How Is Crohn's Disease Diagnosed? Accessibility and Limitations As an immunosuppressant, Skyrizi can increase the risk of infections, including tuberculosis. Skyrizi is not recommended for people who are pregnant, who have a persistent infection, or who have recently received a live vaccine. In clinical trials, one patient was hospitalized for a change in liver function and subsequent rash. The list price for Skyrizi is more than $18,000 per dose. But AbbVie said it offers a patient support program and co-pay card that may reduce the cost to as little as $5 per month for insured patients. What This Means For You If you have active Crohn’s disease, ask your healthcare provider if Skyrizi may be safe and effective for you. Because the drug is licensed for other conditions, it is already available on the market. Was this page helpful? Thanks for your feedback! Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit 4 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Skyrizi [package insert]. North Chicago, IL: AbbVie Inc. Jan. 2022. AbbVie. SKYRIZI® (risankizumab-rzaa) receives FDA approval as the first and only specific interleukin-23 (IL-23) to treat moderately to severely active Crohn's disease in adults. Skyrizi [package insert]. North Chicago, IL: AbbVie Inc. April, 2019. D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. The Lancet. 2022;399(10340):2015-2030. doi:10.1016/S0140-6736(22)00467-6