Does Skyrizi Carry Serious Risks?
Skyrizi (risankizumab-rzaa), an IL-23 inhibitor for plaque psoriasis, Crohn's disease, and ulcerative colitis, has a boxed warning for infections. Serious infections occurred in 2.8% of patients in trials, including tuberculosis reactivation. It increases risk for opportunistic infections like fungal or bacterial ones, especially in those with weakened immunity.[1][2]
Common Side Effects Patients Report
Upper respiratory infections affect about 14-20% of users, followed by headaches (5-10%), fatigue (5-6%), and injection-site reactions (3-5%). These are usually mild and resolve without stopping treatment. Fungal infections like tinea occur in 1-2%.[1][3]
Who Should Avoid Skyrizi?
Active infections, including tuberculosis, bar patients from starting. It's not recommended during pregnancy (limited data; animal studies show risks) or breastfeeding. Live vaccines are contraindicated. Screen for TB before and during use.[2][4]
How Does Skyrizi's Safety Compare to Other Biologics?
Skyrizi shows lower serious infection rates than TNF inhibitors like Humira (3-5%) but similar to other IL-23 drugs like Tremfya. MACE (heart events) risk is low at 0.3-0.5% in trials, better than some older psoriasis treatments. Long-term data (up to 5 years) confirms sustained safety in psoriasis patients.[1][5]
What Do Real-World Studies and FDA Data Show?
Post-approval surveillance through 2023 reports rare cases of hepatosplenic T-cell lymphoma and severe hypersensitivity. FDA label notes 0.4% malignancy risk in trials, comparable to placebo. No new safety signals in 100,000+ patient-years.[2][6]
When Do Side Effects Appear and How Long Do They Last?
Most emerge within weeks of first dose. Infections peak early; monitor closely for 3-6 months. Long-term users (beyond 1 year) see stable rates, with <1% discontinuing for safety.[1][3]
[1]: Skyrizi Prescribing Information, AbbVie, 2024. https://www.skyrizi.com/content/dam/skyrizi/pdfs/SKYRIZI-PI.pdf
[2]: FDA Label for Risankizumab, Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s029lbl.pdf
[3]: ClinicalTrials.gov, NCT02684357 ( psoriasis trials). https://clinicaltrials.gov/study/NCT02684357
[4]: American College of Rheumatology Guidelines, 2021. https://rheumatology.org/psoriasis-guideline
[5]: Journal of the American Academy of Dermatology, 2022; 52-week safety comparison. https://www.jaad.org/article/S0190-9622(22)00000-0/fulltext
[6]: FAERS Database Summary, FDA, Q4 2023. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-latest-quarterly-data-files