Effect of risankizumab on health-related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials.
Peyrin-Biroulet, Laurent; Ghosh, Subrata; Lee, Scott Det al.
2022 • In Alimentary Pharmacology and Therapeutics
Effect of Risankinumab on heath-related quality of life of life of patients with Crohn s...phase 3 MOTIVATE ADVANCE and FORTIFY clinical trials_PPA.pdf
[en] BACKGROUND: Crohn's disease has a substantial negative impact on health-related quality of life (HRQoL). AIM: To examine the effects of risankizumab on HRQoL in Crohn's disease METHODS: We analysed data from patients with Crohn's disease from 12-week induction trials ADVANCE (N = 850) and MOTIVATE (N = 569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52-week maintenance trial FORTIFY (N = 462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-item Short Form Health Survey (SF-36), EuroQol 5-Dimension-5-Level (EQ-5D-5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52. RESULTS: At week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT-F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF-36 physical and mental component summary scores, EQ-5D-5L and activity impairment within work productivity measures. CONCLUSIONS: Risankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease-specific and general patient-reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Peyrin-Biroulet, Laurent; Department of Gastroenterology, University of Lorraine, CHRU-Nancy, Nancy, ; University of Lorraine, Inserm, NGERE, Nancy, France.
Ghosh, Subrata; APC Microbiome Ireland, University College Cork, Cork, Ireland.
Lee, Scott D ; University of Washington, Seattle, Washington, USA.
Lee, Wan-Ju; AbbVie Inc., North Chicago, Illinois, USA.
Griffith, Jenny; AbbVie Inc., North Chicago, Illinois, USA.
Wallace, Kori; AbbVie Inc., North Chicago, Illinois, USA.
Berg, Sofie; AbbVie Inc., North Chicago, Illinois, USA.
Liao, Xiaomei; AbbVie Inc., North Chicago, Illinois, USA.
Loftus, Edward V Jr ; Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.
Louis, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Language :
English
Title :
Effect of risankizumab on health-related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials.
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