Is Skyrizi Approved for Crohn's Disease?
Yes, Skyrizi (risankizumab-rzaa) is FDA-approved to treat moderately to severely active Crohn's disease in adults. The approval came in June 2022 for induction and maintenance therapy after clinical trials showed it induced clinical remission and endoscopic response in patients who had inadequate responses to other treatments.[1]
How Does Skyrizi Work for Crohn's?
Skyrizi is an IL-23 inhibitor that targets interleukin-23, a cytokine involved in inflammation. In Crohn's disease, it reduces gut inflammation by blocking this pathway, leading to symptom relief like reduced diarrhea, abdominal pain, and fatigue. Trials like ADVANCE and MOTIVATE demonstrated 40-45% remission rates at week 12 for induction, sustained in maintenance phases up to 52 weeks.[1][2]
Who Qualifies for Skyrizi in Crohn's Treatment?
It's indicated for adults with moderate to severe Crohn's who failed conventional therapy, immunomodulators, or biologics like TNF inhibitors. Dosing starts with IV infusions (600 mg at weeks 0, 4, 8) for induction, then subcutaneous 180 mg every 8 weeks for maintenance.[1]
How Does Skyrizi Compare to Other Crohn's Drugs?
Skyrizi offers higher endoscopic remission rates than some TNF inhibitors like Humira (adalimumab). In head-to-head data, it showed better durability against ustekinumab (Stelara), another IL-12/23 inhibitor, due to its IL-23 specificity. Unlike steroids, it avoids broad immunosuppression.[2][3]
| Drug | Target | Endoscopic Remission (Week 12) | Maintenance Dosing |
|------|--------|-------------------------------|-------------------|
| Skyrizi | IL-23 | ~30-40% | SC every 8 weeks |
| Stelara | IL-12/23 | ~20-30% | IV then SC every 8 weeks |
| Humira | TNF | ~15-25% | SC every 2 weeks |
Common Side Effects and Risks
Patients report upper respiratory infections (13%), headache (10%), and joint pain (7%). Serious risks include infections (e.g., TB reactivation), hypersensitivity, and rare hepatosplenic T-cell lymphoma with other immunosuppressants. Screen for infections before starting; live vaccines are contraindicated.[1]
When Does Skyrizi's Patent Expire for Crohn's?
Skyrizi's key composition-of-matter patent (US 8,778,704) expires in 2033, with method-of-use patents for Crohn's extending to 2037-2040. No biosimilars are approved yet; challenges from Amgen and Samsung Bioepis are ongoing.[4]
Cost and Access for Crohn's Patients
A 52-week course costs around $70,000-$80,000 without insurance. AbbVie's myAbbVie Assist program offers copay cards reducing out-of-pocket to $5/month for eligible patients. Check DrugPatentWatch.com for patent details and generics timeline.[4]
[1]: FDA Label - Skyrizi (risankizumab-rzaa), June 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761054s017lbl.pdf
[2]: New England Journal of Medicine - ADVANCE/MOTIVATE Trials, 2022. https://www.nejm.org/doi/full/10.1056/NEJMoa2200248
[3]: Gastroenterology - Head-to-Head Comparisons, 2023.
[4]: DrugPatentWatch.com - Skyrizi Patents. https://www.drugpatentwatch.com/p/tradename/SKYRIZI