Skyrizi (risankizumab) is a new-generation biologic therapy that recently received FDA approval for the treatment of moderately to severely active Ulcerative Colitis (UC) in adults.
It targets the inflammatory pathway by specifically blocking the interleukin-23 (IL-23) protein, a key driver of chronic inflammation in the gut. We detail its mechanism, the dosing phases (IV induction followed by subcutaneous maintenance), and the strong clinical trial results showing symptom relief, visible colon repair, and lasting remission.
6 Key Facts and Clinical Insights on Skyrizi for Ulcerative Colitis
FDA-Approved for UC and CD: Skyrizi is officially approved for adults with moderately to severely active Ulcerative Colitis (UC), in addition to its earlier approvals for Crohn's disease (CD) and various forms of psoriasis, confirming its broad application across inflammatory diseases.
Specific IL-23 Blocker Mechanism: The drug is a monoclonal antibody that selectively targets the p19 subunit of the IL-23 protein. By blocking IL-23, it disrupts a crucial signaling pathway that drives inflammation in the colon, leading to reduced symptoms and mucosal repair.
Two-Phase Dosing Schedule (IV Induction, SC Maintenance): Treatment begins with an Induction Phase of three doses administered via Intravenous (IV) infusion (1200 mg at Weeks 0, 4, and 8) to rapidly bring down severe inflammation. This is followed by a long-term Maintenance Phase using a self-administered Subcutaneous (SC) injection (180 mg or 360 mg) every eight weeks.
Strong Clinical Results in Remission and Repair: Phase 3 trials showed a significantly higher proportion of patients achieved clinical remission and endoscopic improvement (visible colon lining repair) compared to placebo, with noticeable symptom relief (e.g., fewer bloody stools, less bowel urgency) starting as early as four weeks.
Alternative for Biologic Failures: Skyrizi provides a valuable alternative for patients who have had an inadequate response or intolerance to conventional therapies (like corticosteroids) or previous treatments with other biologics, such as TNF inhibitors (e.g., Humira) or integrin receptor antagonists (e.g., Entyvio).
Safety Profile Requires Pre-Screening: Like other immunosuppressants, Skyrizi may increase the risk of infections. Patients must be tested for Tuberculosis (TB) infection prior to starting treatment, and the physician must monitor liver enzymes during the induction phase.
Summary: Skyrizi is an effective, FDA-approved biologic for moderately to severely active Ulcerative Colitis, working by specifically blocking the inflammatory IL-23 protein. Its success is marked by a convenient maintenance schedule (SC every 8 weeks) and strong evidence of both symptom relief and visible colon repair.
