[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Reinisch, Walter ; Clinical Department of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria.
Loftus, Edward V Jr ; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.
Schreiber, Stefan; Department Internal Medicine, University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel, Kiel, Germany.
Rubin, David T ; Inflammatory Bowel Disease Center, The University of Chicago Medicine Chicago, Chicago, IL United States.
LOUIS, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Hecht, Patrick M; AbbVie Inc, North Chicago, IL, United States.
Barrachina, Elena Marced; AbbVie Inc, North Chicago, IL, United States.
Kalabic, Jasmina; AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Vladea, Ramona; AbbVie Inc, North Chicago, IL, United States.
Sharma, Dolly; AbbVie Inc, North Chicago, IL, United States.
Duan, Weijiang Rachel; AbbVie Inc, North Chicago, IL, United States.
Zhang, Yafei; AbbVie Inc, North Chicago, IL, United States.
Panaccione, Remo ; Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
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