Skyrizi Approved for Moderately to Severely Active Crohn Disease

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 (ClinicalTrials.gov Identifier: NCT03105128) and MOTIVATE (ClinicalTrials.gov Identifier: NCT03104413), and one phase 3 maintenance study, FORTIFY (ClinicalTrials.gov 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.

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