Is Skyrizi approved for treating psoriatic arthritis?
Yes, Skyrizi is approved in adults to treat:
- active psoriatic arthritis
- moderate-to-severe plaque psoriasis in people who are candidates for systemic (body-wide) therapy or skin phototherapy (ultraviolet light therapy)
- moderately to severely active Crohn's disease
- moderately to severely active ulcerative colitis in adults.
Skyrizi, from AbbVie, was approved by the FDA for psoriatic arthritis on January 21, 2022.
Skyrizi studies in psoriatic arthritis
The Skyrizi (risankizumab-rzaa) approval for psoriatic arthritis was supported by two Phase 3, placebo controlled studies, KEEPsAKE-1 and KEEPsAKE-2.
In these studies, adult participants treated with Skyrizi received 4 maintenance doses a year, after first receiving two starter doses. The study included patients who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) and / or biologics.
Results demonstrated improved skin and joint symptoms and physical function at week 24 when compared to a placebo.
- In both studies, significantly more patients treated with Skyrizi achieved the primary endpoint ACR20 (a composite measure that captures at least a 20% improvement in swollen and tender joints, plus other measures) at 24 weeks when compared to the group that received placebo.
- Overall, 57.3% and 51.3% of patients receiving Skyrizi achieved ACR20 (a composite measure that captures at least a 20% improvement in swollen and tender joints, plus other measures) compared to 33.5% and 26.5% of those receiving placebo, respectively.
The sponsor reports that no new safety risks were observed in the psoriatic arthritis studies. Skyrizi can lead to serious side effects such as allergic reactions and increased risk of infections. The most common side effects include upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection site reactions (1.5%), and tinea (fungal) infections (1.1%).
Psoriatic arthritis is an inflammatory arthritis associated with plaque psoriasis. Over 30% to 40% of people with plaque psoriasis may develop psoriatic arthritis. Common symptoms are pain, swelling and stiffness, fatigue and loss of ability to fully use the joint.
Other treatments approved by the FDA to treat psoriatic arthritis include:
- Cosentyx (secukinumab)
- Enbrel (etanercept)
- Humira (adalimumab)
- Otezla (apremilast)
- Remicade (infliximab)
- Rinvoq (upadacitinib)
- Selarsdi (ustekinumab-aekn)
- Stelara (ustekinumab)
- Taltz (ixekizumab)
- Tremfya (guselkumab)
- Xeljanz (tofacitinib)
This is not all the information you need to know about Skyrizi for safe and effective use and does not take the place of your healthcare provider's directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.
Related questions
References
- Skyrizi FDA Approval History. Drugs.com. Accessed June 20, 2024 at https://www.drugs.com/history/skyrizi.html
- Skyrizi (risankizumab) prescribing information. 6/2024. AbbVie. North Chicago, Illinois. Accessed June 20, 2024 at https://www.rxabbvie.com/pdf/skyrizi_pi.pdf
- AbbVie Submits Regulatory Applications for Skyrizi (risankizumab) in Psoriatic Arthritis to FDA and EMA. Press release. AbbVie. April 7, 2021. Accessed August 12, 2021 at https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-for-skyrizi-risankizumab-in-psoriatic-arthritis-to-fda-and-ema.htm
Read next
Related medical questions
- What are the new drugs for plaque psoriasis?
- Why should I take folic acid with methotrexate?
- Is triamcinolone acetonide an antifungal cream?
- How do you use clobetasol propionate on your scalp?
- Clobetasol vs. triamcinolone - how do they compare?
- What is a substitute for fluocinonide cream?
- How long does methotrexate stay in your system?
- Halobetasol vs. clobetasol - How do they compare?
- Does taking vitamin D help with psoriasis?
- What causes Plaque Psoriasis?
- Sotyktu vs Otezla: How do they compare?
- Can clobetasol be used for toenail fungus?
- How does Taltz compare to Cosentyx for psoriatic arthritis?
- How long does it take for Skyrizi to work?
- Is fluocinonide an antifungal cream?
- How long does it take for Otezla to work?
- How long does clobetasol stay in your system?
- How long should you use fluocinonide for?
- Does Feverfew interact with any drugs?
- How do you inject Humira?
- Cosentyx vs Humira: How do they compare?
- What are 6 key Taltz side effects to watch out for?
- What's the dosing schedule for Skyrizi?
- What happens if Cosentyx is not refrigerated?
- Who is the actress in the Stelara commercial?
- What is fluocinonide cream good for?
- What is the mechanism of action of infliximab?
- Can Enstilar be used on the scalp?
- What does Otezla do to the body?
- Does Cosentyx cause weight gain or loss?
Drug information
Related support groups
- Psoriasis (102 questions, 307 members)
- Skyrizi (18 questions, 7 members)
- Risankizumab (8 questions, 3 members)
- Plaque Psoriasis (86 questions, 69 members)
- Psoriatic Arthritis (83 questions, 277 members)
- Crohn's Disease (51 questions, 284 members)
- Ulcerative Colitis (64 questions, 186 members)