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Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease.
Schreiber, Stefan; Cross, Raymond K; Panaccione, Remo; D'Haens, Geert; Bossuyt, Peter; Dotan, Iris; Colombel, Jean-Frederic; Louis, Edouard; Dubinsky, Marla C; Kligys, Kristina; Neimark, Ezequiel; Song, Alexandra; Zambrano, Javier; Kalabic, Jasmina; Cheng, Erica; Zhang, Yafei; Ferrante, Marc.
Affiliation
  • Schreiber S; Department Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
  • Cross RK; Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
  • Panaccione R; Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Alberta, Canada.
  • D'Haens G; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
  • Bossuyt P; Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium.
  • Dotan I; Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
  • Colombel JF; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Louis E; Icahn School of Medicine at Mt Sinai, New York, New York, USA.
  • Dubinsky MC; University Hospital CHU of Liège, Liège, Belgium.
  • Kligys K; Icahn School of Medicine at Mt Sinai, New York, New York, USA.
  • Neimark E; AbbVie Inc., North Chicago, Illinois, USA.
  • Song A; AbbVie Inc., North Chicago, Illinois, USA.
  • Zambrano J; AbbVie Inc., North Chicago, Illinois, USA.
  • Kalabic J; AbbVie Inc., North Chicago, Illinois, USA.
  • Cheng E; AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
  • Zhang Y; AbbVie Inc., North Chicago, Illinois, USA.
  • Ferrante M; AbbVie Inc., North Chicago, Illinois, USA.
Article in En | MEDLINE | ID: mdl-39054592
ABSTRACT

BACKGROUND:

Risankizumab is efficacious and well tolerated in adults with moderately to severely active Crohn's disease (CD).

AIM:

To evaluate the corticosteroid-sparing effect of risankizumab in CD.

METHODS:

During the 12-week induction period, patients maintained stable baseline corticosteroid doses, up to 20 mg/day prednisone or equivalent. At week 0 of maintenance, a mandatory corticosteroid taper was started. This post hoc analysis evaluated corticosteroid-free clinical and endoscopic outcomes at week 52 of maintenance; safety was also assessed.

RESULTS:

Of 889 patients randomised to induction with risankizumab 600 mg or placebo, 285 (32.1%) were taking baseline concomitant corticosteroids. Week 12 clinical remission and endoscopic response rates were greater for risankizumab 600 mg versus placebo, regardless of concomitant corticosteroid use. At week 52, 66.7%, 50.0% and 41.2% of patients taking risankizumab 180 mg, risankizumab 360 mg and (withdrawal) placebo, respectively, discontinued corticosteroids. Week 52 corticosteroid-free clinical remission per stool frequency/abdominal pain score (risankizumab 180 mg [42.7%] or 360 mg [49.8%]; [withdrawal] placebo [39.0%]), corticosteroid-free clinical remission per Crohn's Disease Activity Index (risankizumab 180 mg [51.0%] or 360 mg [49.5%]; [withdrawal] placebo [40.2%]), and corticosteroid-free endoscopic response (risankizumab 180 mg [44.6%] or 360 mg [44.7%]; [withdrawal] placebo [20.7%]) rates were greater for risankizumab than placebo. Adverse event rates were generally similar, regardless of baseline corticosteroid use.

CONCLUSIONS:

Efficacy of risankizumab 600 mg induction therapy was independent of concomitant corticosteroid use. Risankizumab 180 and 360 mg maintenance therapy yielded high rates of corticosteroid-free clinical and endoscopic outcomes at week 52.

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Aliment Pharmacol Ther Journal subject: FARMACOLOGIA / GASTROENTEROLOGIA / TERAPIA POR MEDICAMENTOS Year: 2024 Document type: Article Affiliation country: Germany Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: Aliment Pharmacol Ther Journal subject: FARMACOLOGIA / GASTROENTEROLOGIA / TERAPIA POR MEDICAMENTOS Year: 2024 Document type: Article Affiliation country: Germany Country of publication: United kingdom