Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis

Autor: Brian G Feagan, Toshifumi Hibi, Vipul Jairath, Nathan Morris, Bruce E Sands, Marla C Dubinsky, Vipin Arora, April N Naegeli, Trevor Lissoos, Mingyang Shan, Jay Tuttle, Noah Agada
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMJ Open Gastroenterology, Vol 10, Iss 1 (2023)
Druh dokumentu: article
ISSN: 2054-4774
DOI: 10.1136/bmjgast-2023-001115
Popis: Objective Mirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality of life (HRQoL).Design HRQoL was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and 36-Item Short Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS). Mixed effects models for repeated measures compared score changes between mirikizumab and placebo groups. Additional analyses evaluated associations between HRQoL score changes and achievement of efficacy endpoints at weeks 12 and 52.Results At week 12, IBDQ improved compared with placebo for all mirikizumab groups except mirikizumab 50 mg (50 mg, p=0.073; 200 mg, p
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