What is Skyrizi used for and how does it work?
What is Skyrizi used for?
Skyrizi (risankizumab) is a FDA approved medicine used to treat adult patients who have:
- moderate or severe plaque psoriasis (raised, silvery flaking of the skin) which is an ongoing autoimmune condition, which causes inflammation and increased immune response
- active psoriatic arthritis (PsA) which is a systemic inflammatory disease which affects the skin and joints
- moderately to severely active Crohn's disease which is a chronic, systemic disease that causes inflammation in the digestive tract with symptoms of persistent diarrhea and abdominal pain.
How does Skyrizi work?
- Skyrizi is an immunosuppressant that reduces PP by blocking a small protein called interleukin 23 cytokine (IL23), which is a messenger for inflammation and immune response.
- Once IL23 is blocked the inflammation is decreased and the plaque psoriasis improves.
- Skyrizi is an injection given under the skin (subcutaneous injection) on week 0 and week 4, then after these first two doses it is given every 12 weeks.
- Psoriasis trials: In the clinical trial UltIMMa-12 they looked at how many patients had a 90% reduction in their psoriasis score after 16 weeks of treatment. Skyrizi had the best improvement with a reduction in psoriasis by 75%, Ustekinumab had a reduction of 42% and patients on a placebo injection had only 2% reduction.
- Psoriatic arthritis trials: In the studies KEEPsAKE-1 and KEEPsAKE-2 looked at how well Skyrizi worked for PsA after 24 weeks. It meets the endpoint of ACR20 which is a combined measure showing there was a 20% improvement in the number of tender and swollen joints, this also includes a 20% improvement in pain, functional ability measure, and doctor and patient assessment of PsA.
- Crohn’s disease trials: In the clinical trials ADVANCE, MOTIVATE and FORTIFY1 in as early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with Skyrizi versus placebo, as were co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52.
- Skyrizi is FDA approved medicine to treat plaque psoriasis in adults who have moderate to severe psoriasis that is at the stage that requires systemic treatment or ultraviolet light treatment.
- Skyrizi is FDA approved medicine to treat active psoriatic arthritis in adults.
- Skyrizi is FDA approved medicine to treat moderate to severely active Crohn's disease.
- Skyrizi works by blocking IL23 which reduces inflammation and improves plaque psoriasis.
- Skyrizi Medication information [Accessed February 2, 2022] https://www.drugs.com/skyrizi.html
- What are the new drugs for the treatment of plaque psoriasis? [Accessed February 2, 2022] https://www.drugs.com/medical-answers/new-drugs-treatment-plaque-psoriasis-3511670/
- Risankizumab for psoriasis [Accessed February 2, 2022 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186275/
- Interleukin-23: a key cytokine in inflammatory diseases [Accessed February 2, 2022] https://www.ncbi.nlm.nih.gov/pubmed/21585245
- Efficacy and Safety of Risankizumab, a Selective IL-23P19 Inhibitor, in Patients with Active Psoriatic Arthritis over 24 weeks: Results from a Phase 2 Trial [Accessed February 2, 2022] https://ard.bmj.com/content/annrheumdis/77/Suppl_2/200.full.pdf
- Highlights of prescribed information for Skyrizi [Accessed February 2, 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf
- U.S. FDA Approves Second Indication for Skyrizi (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis [Accessed February 2, 2022] https://www.drugs.com/newdrugs/u-s-fda-approves-second-indication-skyrizi-risankizumab-rzaa-adults-active-psoriatic-arthritis-5773.html
- 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 [Accessed August 11, 2022] https://www.drugs.com/newdrugs/skyrizi-risankizumab-rzaa-receives-fda-approval-first-only-specific-interleukin-23-il-23-moderately-5853.html
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- Skyrizi Information for Consumers
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- Side Effects of Skyrizi (detailed)