FDA approved Skyrizi (risankizumab) for Ulcerative Colitis in AdultsFDA approved Skyrizi for ulcerative colitis, a new treatment option.

Skyrizi (risankizumab) is an interleukin-23 antagonist. It blocks IL-23 by binding to its p19 subunit, inhibiting IL-23-mediated signaling and reducing inflammatory responses.

Skyrizi is indicated for the treatment of moderately to severely active ulcerative colitis in adults. It is also indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, active psoriatic arthritis in adults, and moderately to severely active Crohn's disease in adults.

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. For plaque psoriasis and psoriatic arthritis, the dosage is 150 mg subcutaneously at Week 0, Week 4, and every 12 weeks thereafter. For Crohn's disease, induction is 600 mg IV over at least one hour at Week 0, 4, and 8; maintenance is 180 mg or 360 mg subcutaneously every 8 weeks starting at Week 12.

Trial data not available in label.

Not reported in label.

Skyrizi provides an additional biologic option for adults with moderately to severely active ulcerative colitis. It can be used alone or in combination with non-biologic DMARDs for psoriatic arthritis. For Crohn's disease and ulcerative colitis, liver enzymes and bilirubin should be monitored. The label does not specify comparative efficacy or safety versus other therapies.