FDA approved Skyrizi (risankizumab) for Ulcerative Colitis in AdultsFDA approved Skyrizi for adults with moderate to severe ulcerative colitis.

FDA From the archive Source published June 16, 2022 Summary added June 18, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Skyrizi as a treatment option for adults with moderately to severely active ulcerative colitis, using the lowest effective maintenance dose.

The FDA has approved Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis in adults, expanding the interleukin-23 antagonist's indications. The approval adds to existing indications for plaque psoriasis, psoriatic arthritis, and Crohn's disease. For ulcerative colitis, the recommended induction regimen is 1,200 mg administered by intravenous infusion over at least two hours at weeks 0, 4, and 8. Maintenance dosing is 180 mg or 360 mg subcutaneously at week 12 and every 8 weeks thereafter, with clinicians advised to use the lowest effective dose. Prior to initiation, liver enzymes and bilirubin should be assessed, and patients should be evaluated for tuberculosis. This approval provides a new biologic option for adults with ulcerative colitis who have not responded adequately to conventional therapy.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Skyrizi is an interleukin-23 antagonist.

Indication & Patient Population

Skyrizi is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Dosing & Administration

For 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. Prior to initiation, obtain liver enzymes and bilirubin levels, evaluate for tuberculosis, and complete age-appropriate vaccinations.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Skyrizi provides a new biologic option for adults with moderately to severely active ulcerative colitis, with a dosing regimen that includes intravenous induction followed by subcutaneous maintenance.

The FDA has approved Skyrizi (risankizumab) for adults with moderate to severe ulcerative colitis. This is a type of inflammatory bowel disease that causes inflammation and sores in the lining of the large intestine. Skyrizi is a biologic drug that blocks a protein called interleukin-23, which plays a role in inflammation.

Skyrizi is for adults who have not responded well enough to other treatments. The treatment starts with three intravenous (IV) infusions given over at least two hours each, at weeks 0, 4, and 8. After that, patients give themselves a shot under the skin every 8 weeks, starting at week 12. The dose may be adjusted to the lowest effective amount.

This approval adds to Skyrizi's other uses for plaque psoriasis, psoriatic arthritis, and Crohn's disease. Before starting Skyrizi, doctors will check liver enzymes and test for tuberculosis. Common side effects include upper respiratory infections, headache, and injection site reactions.

While this is a new option, it is not a cure. Patients should talk to their doctor to see if Skyrizi is right for them. It is important to discuss your medical history and any other medicines you take.

What this means for you:

Skyrizi is a new treatment option for ulcerative colitis, but it is not a cure. Talk to your doctor.

Study Details

Study typeFda approval

PublishedJun 2022

View Original Abstract ↓

1 INDICATIONS AND USAGE SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 ) 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. 1.3 Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

FDA approved Skyrizi (risankizumab) for Ulcerative Colitis in AdultsFDA approved Skyrizi for adults with moderate to severe ulcerative colitis.

Study Details

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FDA approved Skyrizi (risankizumab) for Ulcerative Colitis in AdultsFDA approved Skyrizi for adults with moderate to severe ulcerative colitis.

Study Details

Guselkumab Phase III trials validate 3VAS and 4VAS measures for psoriatic arthritis disease activity assessment

Study checks how well pain scores track joint damage in psoriatic arthritis patients

Clinical research that matters. Delivered to your inbox.

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