Yes, Skyrizi is FDA-approved for Crohn's disease
Skyrizi (risankizumab-rzaa) gained FDA approval in June 2022 for moderately to severely active Crohn's disease in adults, following positive results from the Phase 3 ADVANCE and MOTIVATE trials. These trials showed 40-45% of patients achieved clinical remission at week 12, compared to 20-24% on placebo.[1] It's administered via intravenous induction (600 mg at weeks 0, 4, and 8), followed by subcutaneous maintenance (180 mg or 360 mg every 8 weeks).[2]
How does Skyrizi work in Crohn's?
Skyrizi targets interleukin-23 (IL-23), a cytokine driving inflammation in Crohn's disease. By blocking IL-23, it reduces gut inflammation without broadly suppressing the immune system like some older biologics. This mechanism also underpins its approvals for psoriasis, psoriatic arthritis, and ulcerative colitis.[1][3]
Who qualifies for Skyrizi in Crohn's treatment?
It's for adults with moderate-to-severe Crohn's who have inadequate response, intolerance, or contraindications to conventional therapy (e.g., steroids, immunomodulators) or other biologics like TNF inhibitors. Endoscopic improvement is a key endpoint in trials, making it suitable for patients needing mucosal healing.[2]
How effective is it compared to other Crohn's drugs?
In head-to-head data, Skyrizi showed higher remission rates than ustekinumab (Stelara) in some analyses, with 71% endoscopic response at week 52 versus 58% for Stelara. Versus TNF inhibitors like Infliximab (Remicade), it offers similar efficacy but potentially better durability in IL-23-naive patients. Real-world studies confirm sustained remission in 60-70% at one year.[3][4]
| Drug | Remission at Week 12 (Induction) | Maintenance Dosing |
|------|----------------------------------|-------------------|
| Skyrizi | 40-45% | SC every 8 weeks |
| Stelara | 32-40% | SC every 8 weeks |
| Infliximab | 40-50% | IV every 8 weeks |
Common side effects and risks
Upper respiratory infections (13%), headache (10%), and joint pain (6%) top the list. Serious risks include infections (e.g., TB reactivation), hypersensitivity, and malignancy. No increased risk of hepatosplenic T-cell lymphoma seen in trials, unlike some anti-TNFs. Monitor for liver enzyme elevations.[2]
When does Skyrizi's patent expire for Crohn's?
Core patents on risankizumab expire around 2033-2037 in the US, with formulation and method-of-use patents extending protection. No generics or biosimilars approved yet; check DrugPatentWatch.com for litigation updates on Paragraph IV challenges.[5]
Cost and access for Crohn's patients
List price is about $17,000 per induction dose and $12,000-$20,000 monthly for maintenance, varying by weight/dose. Patient assistance programs from AbbVie cover copays under $5 for eligible insured patients. Prior authorizations often require failed conventional therapies.[6]
[1] FDA Approval Announcement: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-skyrizi-risankizumab-rzaa-crohns-disease
[2] Skyrizi Prescribing Information: https://www.skyrizi.com/content/dam/skyrizi/pdfs/Skyrizi-PI.pdf
[3] NEJM Phase 3 Trial (ADVANCE/MOTIVATE): https://www.nejm.org/doi/full/10.1056/NEJMoa2201157
[4] Comparative Efficacy Review: https://pubmed.ncbi.nlm.nih.gov/37318217/
[5] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/SKYRIZI
[6] AbbVie Patient Support: https://www.skyrizi.com/crohns-disease/savings-and-support