Skyrizi Approved for Moderately to Severely Active Crohn Disease

The approval was based on data from two phase 3 induction studies, and one phase 3 maintenance study.

The Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of moderately to severely active Crohn disease (CD) in adults.

The approval was based on data from two phase 3 induction studies, ADVANCE ( Identifier: NCT03105128) and MOTIVATE ( Identifier: NCT03104413), and one phase 3 maintenance study, FORTIFY ( Identifier: NCT03105102). The studies evaluated the efficacy and safety of Skyrizi, an interleukin-23 inhibitor, in adults with moderate to severe CD. 

In the ADVANCE and MOTIVATE studies, patients were randomly assigned to receive Skyrizi 600mg, 1200mg, or placebo as intravenous (IV) induction therapy. In the FORTIFY study, patients who responded to IV induction therapy were then randomly assigned to receive Skyrizi 360mg or placebo.

Results from ADVANCE and MOTIVATE showed a greater proportion of patients treated with Skyrizi 600mg met the following efficacy endpoints vs placebo at week 12, respectively (all P <.001):

  • Clinical remission (primary endpoint; as measured by Crohn Disease Activity Index [CDAI]): 45% and 42% vs 25% and 20%;
  • Endoscopic response (primary endpoint; defined as a decrease in Simple Endoscopic score for CD [SES-CD] of >50% from the baseline or a decrease of at least 2 points for patients with a baseline score of 4 and isolated ileal disease, based on central reading): 40% and 29% vs 12% and 11%;
  • Clinical response (defined as a reduction of CDAI ≥100 points from baseline): 60% and 60% vs 37% and 30%;
  • Endoscopic remission (defined as SES-CD ≤4 and at least a 2-point reduction from baseline, with no individual subscore greater than 1, based on central reading): 24% and 19% vs 9% and 4%.

Findings showed that the onset of clinical response and clinical remission occurred as early as week 4 in a greater proportion of patients in the Skyrizi arm. The Skyrizi 1200mg dosage did not demonstrate additional treatment benefit over the 600mg dosage and is not a recommended regimen.

In the FORTIFY study, results showed that 57% and 48% of patients treated with Skyrizi 360mg achieved clinical remission and endoscopic response, respectively, at week 52 vs 46% and 22% of those who received placebo (both P <.05). Moreover, 41% of patients treated with Skyrizi 360mg achieved endoscopic remission compared with 13% of those who received placebo; this endpoint was not statistically significant.

The most common adverse reactions reported with Skyrizi during induction treatment were upper respiratory infections, headache, and arthralgia. During maintenance treatment, arthralgia, injection site reactions, abdominal pain, anemia, pyrexia, back pain, arthropathy, and urinary tract infections were most commonly reported.

For CD patients, Skyrizi will be supplied in a 600mg/10mL single-dose vial for IV infusion during the induction period (for administration by a health care provider) and a 360mg/2.4mL single-dose prefilled cartridge (to be used with the on-body injector) for subcutaneous injection for maintenance treatment (may self-inject after training by provider). A 180mg self-administered maintenance dose is currently under review by the FDA.

“We are proud to offer the first new treatment option in 6 years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement,” said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie.

Skyrizi is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.


  1. Skyrizi® (risankizumab-rzaa) receives FDA approval as the first and only specific interleukin-23 (IL-23) to treat moderately to severely active Crohn’s disease in adults. News release. AbbVie. Accessed June 17, 2022.
  2. Skyrizi. Package insert. AbbVie; 2022. Accessed June 17, 2022.