Risankizumab Maintenance Therapy Viable Option in Crohn Disease per FDA Criteria

Risankizumab maintenance therapy is safe and efficacious in patients with moderate to severe active CD who achieved clinical response to induction therapy.

Maintenance therapy with risankizumab is safe and efficacious after achieving a clinical response with induction therapy among patients with moderate to severe Crohn disease (CD), according to study results presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2022 conference, held from December 5 to 7, 2022, in Orlando, Florida.

Risankizumab, an inhibitor of interleukin 23, was found to be safe and efficacious using European Medicines Agency (EMA)-recommended criteria in the FORTIFY trial (ClinicalTrials.gov Identifier: NCT03105102) as an induction and maintenance therapy among patients with moderate to severe CD. For this posthoc analysis, data from the FORTIFY trial were reevaluated using the Food and Drug Administration (FDA)-recommended criteria of clinical response of Crohn’s Disease Activity Index (CDAI).

In FORTIFY, patients who achieved a clinical response after 12 weeks of risankizumab induction therapy were randomly assigned to receive 180 mg or 360 mg subcutaneous risankizumab or placebo maintenance therapy every 8 weeks for 52 weeks. For the current study, clinical remission was defined as CDAI less than 150 and endoscopic response as a greater than 50% decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) or a 2-point or greater reduction in SES-CD score among patients with isolated ileal disease.

The posthoc analysis included 382 patients who received 180 mg (n=135) or 360 mg (n=117) risankizumab and placebo (n=130) maintenance therapy.

Risankizumab was superior to placebo for achieving clinical remission and endoscopic response at week 52…

At 52 weeks, the rate of clinical remission was 46.2% in the placebo group, which was significantly smaller than the low- (61.5%; P <.05) and high- (56.8%; P <.05) dose risankizumab groups.

Stratified by biologic therapy intolerance status, patients who were not intolerant had numerically higher clinical remission rates (75.0%, 70.6%, 64.5%) than patients with intolerance (55.8%, 51.1%, 40.4%) among the low- and high-dose risankizumab and placebo groups, respectively.

Endoscopic response rates were higher among low- (50.4%; P <.001) and high- (48.4%; P <.001) dose risankizumab cohorts compared with placebo (21.5%). Similar to clinical remission, endoscopic response rates were numerically higher among the subset of patients who were not intolerant to biologic therapy compared with intolerant patients.

Among the risankizumab recipients, the high-dose regimen was favored over the low-dose regimen for ulcer-free endoscopy (32.6% vs 25.2%), endoscopic remission (41.2% vs 32.6%), and deep remission (32.6% vs 28.1%) outcomes, respectively.

No significant differences in adverse event rates, serious adverse event rates, and the rate of adverse events leading to discontinuation were reported.

The study authors concluded that efficacy and safety outcomes using FDA-recommended criteria were similar to what was reported in the original FORTIFY trial, which used EMA criteria.

“Risankizumab was superior to placebo for achieving clinical remission and endoscopic response at week 52, more stringent endpoints (endoscopic remission/deep remission) were consistent with a dose-response relationship, and risankizumab maintenance treatment was generally well tolerated,” the study authors wrote.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Dubinsky M, Rubin D, Rieder F, et al. Risankizumab maintenance therapy is effective in patients achieving CDAI clinical response with induction therapy: post hoc analysis from FORTIFY. Abstract presented at: AIBD 2022; December 5-7, 2022; Orlando, FL. Abstract 87.