AbbVie SKYRIZI (risankizumab-rzaa) Monograph

Published: October 17, 2025

SKYRIZI (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, received U.S. Food and Drug Administration (FDA) approval for the treatment of ulcerative colitis in June 2024. Prior to this indication, SKYRIZI had been approved for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Additionally, several medical society guidelines now feature recommendations regarding trisankizumab, as outlined below.

Currently, no additional regulatory submissions are publicly reported. However, upcoming and ongoing clinical trials may support future label expansions for other chronic inflammatory conditions, such as IBD, as well as potential pediatric indications, depending on trial outcomes.

SKYRIZI General Overview:

Brand Name: SKYRIZI
Generic Name: risankizumab-rzaa
Treatment for: Moderate to severe plaque psoriasis; active psoriatic arthritis; moderately to severely active Crohn’s disease; ulcerative colitis.
Manufacturer(s): AbbVie
Initial FDA Approval: April 2019

SKYRIZI Indications Overview

Indicated Condition	Indication	Age	Approval Date
Plaque Psoriasis	SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.	Adults	April 2019
Psoriatic Arthritis	SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.	Adults	January 2022
Crohn's Disease	SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.	Adults	June 2022
Ulcerative Colitis	SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults	Adults	June 2024

Warnings and Precautions

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur.

Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, do not administer SKYRIZI until the infection resolves.

Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI.

Hepatotoxicity in Treatment of Inflammatory Bowel Disease: Drug-induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment. Monitor thereafter according to routine patient management.

Administration of Vaccines: Avoid use of live vaccines.

Dosage and Administration:

For the treatment of Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI.

Complete all age-appropriate vaccinations as recommended by current immunization guidelines.

Recommended Dosage:

Plaque Psoriasis and Psoriatic Arthritis:
- 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
- In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).

Crohn’s Disease:
- The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.

Ulcerative Colitis:
- The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.

Contraindications:

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.

Adverse Reactions:

Most common adverse reactions are:

Plaque Psoriasis and Psoriatic Arthritis (≥ 1%):
- Upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

Crohn’s Disease (>3%):
- Induction: upper respiratory infections, headache, and arthralgia.
- Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.

Ulcerative Colitis (≥3%):
- Induction: arthralgia.
- Maintenance: arthralgia, pyrexia, injection site reactions, and rash.

Examples of Risankizumab in Guidelines

Ulcerative Colitis in Adults

American College of Gastroenterology (ACG), June 2025
- “In patients with moderately to severely active UC, we recommend the IL23p19 inhibitor guselkumab, mirikizumab, or risankizumab for induction of remission (Strong recommendation, moderate quality of evidence).”
- “We recommend continuing guselkumab, mirikizumab, or risankizumab as compared with no treatment for maintenance of remission in patients who respond to the induction dosing of the same treatment (Strong recommendation, moderate quality of evidence).”

Management of Crohn’s Disease in Adults

American College of Gastroenterology (ACG), June 2025
- “We recommend the use of risankizumab for induction and maintenance of remission in patients with moderate to severely active CD (strong recommendation, moderate level of evidence).”
- “We recommend the use of risankizumab as compared with ustekinumab in patients with moderate-to-severe CD and prior exposure to anti-TNF therapy (conditional recommendation low level of evidence).”

Management of Moderate to Severe Ulcerative Colitis

American Gastroenterological Association (AGA), December 2024
- “In adult outpatients with moderate-to-severe ulcerative colitis, the use of the following agents is recommended: infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab, and guselkumab.”
- “In adult outpatients with moderate-to-severe ulcerative colitis who have not yet taken any advanced therapies, HIGHER efficacy medication (infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, guselkumab) OR an INTERMEDIATE efficacy medication (golimumab, ustekinumab, tofacitinib, filgotinib, mirikizumab), should be used rather than a LOWER efficacy medication (adalimumab).”

Please note: This article is current as of October 16, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.