FDA OKs Risankizumab for Crohn’s DiseaseJune 17, 2022
The FDA has approved risankizumab (Skyrizi), an interleukin (IL)-23 inhibitor, for the treatment of moderately to severely active Crohn’s disease, AbbVie announced on Friday.
The approval for Crohn’s disease was based on phase III data demonstrating the safety and efficacy of risankizumab in two induction trials, ADVANCE and MOTIVATE, and the FORTIFY maintenance trial.
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” said Marla Dubinsky, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in a press release. “This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease.”
In the induction trials, patients who received risankizumab achieved clinical response and clinical remission as early as week 4, and the studies met the co-primary endpoints of clinical remission (defined as a Crohn’s Disease Activity Index of less than 150) and endoscopic response (a decrease of greater than 50% in baseline Simple Endoscopic Score in Crohn’s Disease) at week 12. A greater number of risankizumab patients also achieved clinical remission and endoscopic response after 1 year compared with placebo in the maintenance trial.
An open-label extension of FORTIFY is ongoing to evaluate the long-term safety of risankizumab.
Crohn’s disease, an inflammatory bowel disease, causes chronic diarrhea with abdominal pain. A progressive disease with signs and symptoms that can be unpredictable, Crohn’s can lead to significant disability and may require surgery in some cases.
Risankizumab works by selectively blocking the inflammatory cytokine, IL-23, by binding to its p19 subunit, thereby reducing inflammation.
The approved dose for adults with Crohn’s is 600 mg administered by intravenous infusion over at least 1 hour at weeks 0, 4, and 8, followed by 360 mg administered by subcutaneous injection at week 12, and then every 8 weeks.
Risankizumab may cause serious adverse events, including infections and allergic reactions.
The most common treatment-related adverse events for patients with Crohn’s disease included upper respiratory infections, fever, injection site reactions, headache, and anemia, as well as abdominal, back, and joint pain.