Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis

J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.

Abstract

Background and aims: This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis in the phase 3 induction and maintenance studies, INSPIRE and COMMAND.

Methods: Patients were randomized (2:1) to 12 weeks of intravenous RZB or placebo (PBO) induction therapy; responders to intravenous RZB were randomized (1:1:1) to receive subcutaneous RZB 180 mg, 360 mg, or PBO (RZB withdrawal) maintenance therapy. Baseline corticosteroid doses were maintained during induction, with a mandatory taper beginning at maintenance week 0. Efficacy outcomes were evaluated by baseline corticosteroid use at induction week 12, while corticosteroid-free clinical and endoscopic outcomes were assessed at maintenance week 52 among the overall population and among patients on corticosteroids at baseline. Safety was also assessed.

Results: At baseline, 35.7% (348/975) of patients were taking corticosteroids. At induction week 12, greater rates were observed for clinical, endoscopic, and patient-reported outcomes in RZB 1200 mg-treated patients compared with PBO, regardless of baseline corticosteroid use. RZB 180 mg and 360 mg treatment resulted in higher corticosteroid discontinuation rates (RZB 180 mg 64.9% [48/74]; RZB 360 mg 54.2% [32/59]; PBO [withdrawal] 36.8% [25/68], P ≤ .01) and corticosteroid-free clinical, endoscopic, and patient-reported outcomes at week 52, compared with PBO (withdrawal). The rates of treatment-emergent adverse events were similar regardless of baseline corticosteroid use during induction and maintenance.

Conclusions: The efficacy of RZB induction therapy was independent of corticosteroid use, with high rates of corticosteroid-free outcomes observed in the overall population and among patients with baseline corticosteroid use, reaffirming the potential of RZB to serve as a corticosteroid-sparing therapy for patients with ulcerative colitis.

Clinicaltrial.gov numbers: NCT03398148 and NCT03398135.

Keywords: IL-23 inhibitor; corticosteroids; risankizumab; ulcerative colitis.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III

MeSH terms

  • Adrenal Cortex Hormones* / administration & dosage
  • Adrenal Cortex Hormones* / therapeutic use
  • Adult
  • Antibodies, Monoclonal* / administration & dosage
  • Colitis, Ulcerative* / diagnosis
  • Colitis, Ulcerative* / drug therapy
  • Double-Blind Method
  • Female
  • Gastrointestinal Agents* / administration & dosage
  • Gastrointestinal Agents* / adverse effects
  • Gastrointestinal Agents* / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Adrenal Cortex Hormones
  • risankizumab
  • Gastrointestinal Agents
  • Antibodies, Monoclonal

Associated data

  • ClinicalTrials.gov/NCT03398148
  • ClinicalTrials.gov/NCT03398135

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