This decision is supported by two Phase 3 clinical trials, INSPIRE and COMMAND. The INSPIRE study focused on a 12-week induction period, while the COMMAND study examined a 52-week maintenance period. Both trials demonstrated that patients achieved clinical remission, the primary endpoint, and showed significant endoscopic improvements, a key secondary endpoint.
Clinical Trial Insights
INSPIRE Induction Study
The INSPIRE study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial assessing the efficacy and safety of 1200 mg risankizumab administered intravenously every four weeks over 12 weeks in patients with moderately to severely active ulcerative colitis. The primary endpoint was clinical remission at week 12, measured by the Adapted Mayo Score, which includes stool frequency, rectal bleeding, and endoscopic appearance. Secondary endpoints included clinical response and endoscopic improvement.
COMMAND Maintenance Study
The COMMAND study was a Phase 3, multicenter, randomized, double-blind trial that evaluated the efficacy and safety of risankizumab as maintenance therapy over 52 weeks. Patients who responded to the induction therapy in the INSPIRE study were re-randomized to receive either 180 mg or 360 mg of risankizumab subcutaneously, or a placebo, to assess maintenance of clinical remission. The study also examined secondary endpoints such as endoscopic improvement and steroid-free clinical remission.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease that affects the large intestine, causing continuous inflammation and ulcers in the lining of the colon and rectum. Common symptoms include abdominal pain, rectal bleeding, bloody diarrhea, and an urgent need to defecate. The severity and progression of the disease vary among patients, with some experiencing mild symptoms and others facing severe complications, including an increased risk of colorectal cancer.
For the treatment of ulcerative colitis, Skyrizi is administered initially through a 12-week induction period with three doses of 1200 mg delivered every four weeks. Following this induction phase, maintenance therapy is continued with either 180 mg or 360 mg every eight weeks. Patients can administer the maintenance doses at home using an on-body injector (OBI), a device designed for ease of use and patient convenience.
Skyrizi overview
Skyrizi is an interleukin-23 (IL-23) inhibitor that works by selectively targeting and blocking the p19 subunit of IL-23, a cytokine involved in inflammatory processes associated with several chronic immune-mediated diseases. Skyrizi is approved for the treatment of moderate to severe ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease.
The FDA approval of Skyrizi for ulcerative colitis marks another advancement in the treatment, providing a new therapeutic option for patients suffering from moderate to severe forms of the condition.
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