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, Remoet al.
2024 • In Alimentary Pharmacology and Therapeutics, 60 (7), p. 897-906
[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Schreiber, Stefan ; Department Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Cross, Raymond K; Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Panaccione, Remo ; Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Alberta, Canada.
D'Haens, Geert; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Bossuyt, Peter; Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium.
Dotan, Iris; Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel. ; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Colombel, Jean-Frederic ; Icahn School of Medicine at Mt Sinai, New York, New York, USA.
Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Dubinsky, Marla C ; Icahn School of Medicine at Mt Sinai, New York, New York, USA.
Kligys, Kristina; AbbVie Inc., North Chicago, Illinois, USA.
Neimark, Ezequiel; AbbVie Inc., North Chicago, Illinois, USA.
Song, Alexandra; AbbVie Inc., North Chicago, Illinois, USA.
Zambrano, Javier; AbbVie Inc., North Chicago, Illinois, USA.
Kalabic, Jasmina; AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Cheng, Erica; AbbVie Inc., North Chicago, Illinois, USA.
Zhang, Yafei; AbbVie Inc., North Chicago, Illinois, USA.
Ferrante, Marc ; Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
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.
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