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

被引:4
作者
Dubinsky, Marla C. [1 ]
Jairath, Vipul [2 ,3 ,4 ]
Feagan, Brian G. [2 ,3 ,4 ]
Naegeli, April N. [5 ]
Tuttle, Jay [6 ]
Morris, Nathan [5 ]
Shan, Mingyang [5 ]
Arora, Vipin [5 ]
Lissoos, Trevor [5 ]
Agada, Noah [5 ]
Hibi, Toshifumi [7 ]
Sands, Bruce E. [8 ]
机构
[1] Icahn Sch Med, Dept Pediat, New York, NY 10029 USA
[2] Alimentiv Inc, London, ON, Canada
[3] Western Univ, Dept Med, London, ON, Canada
[4] Western Univ, Dept Epidemiol & Biostat, London, ON, Canada
[5] Eli Lilly & Co, Indianapolis, IN USA
[6] Lilly Biotechnol Ctr, San Diego, CA USA
[7] Kitasato Inst Hosp, Ctr Adv IBD Res & Treatment, Tokyo, Japan
[8] Icahn Sch Med Mt Sinai, Dr Henry D Janowitz Div Gastroenterol, New York, NY USA
来源
BMJ OPEN GASTROENTEROLOGY | 2023年 / 10卷 / 01期
关键词
ULCERATIVE COLITIS; QUALITY OF LIFE; IMMUNOTHERAPY; TRIALS; SF-36; IL-23;
D O I
10.1136/bmjgast-2023-001115
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
ObjectiveMirikizumab, 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).DesignHRQoL 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.ResultsAt week 12, IBDQ improved compared with placebo for all mirikizumab groups except mirikizumab 50 mg (50 mg, p=0.073; 200 mg, p<0.001; 600 mg, p<0.001). SF-36 PCS was significantly higher in all mirikizumab groups at week 12 (50 mg, p=0.011; 200 mg, p=0.022; 600 mg, p=0.002); MCS was significantly higher in mirikizumab 200 and 600 mg groups compared with placebo (50 mg, p=0.429; 200 mg, p=0.028; 600 mg, p<0.001). Achievement of clinical response and remission were associated with greater HRQoL improvements at week 12. Improvements in HRQoL scores were sustained through week 52. Of the clinical symptoms evaluated, reduction in rectal bleeding was associated with greater improvements in IBDQ and SF-36 scores.ConclusionMirikizumab improved HRQoL in patients with moderately-to-severely active UC.
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页数:11
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