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  • S910 Mirikizumab Sustains I...
    Rubin, David T.; Hibi, Toshifumi; Gibble, Theresa Hunter; Chan, Lai Shan; Lin, Zhantao; Protic, Marijana; Jairath, Vipul

    The American journal of gastroenterology, 10/2023, Letnik: 118, Številka: 10S
    Journal Article

    Introduction: Mirikizumab (miri) treatment improved quality of life in patients with moderately-to-severely active Crohn’s disease (CD) through Week 52 (W52) as assessed by Medical Outcomes 36-Item Short Form Health Survey (SF-36) scores in the Phase 2 randomized, double-blind, parallel, placebo (PBO)-controlled study (SERENITY/NCT02891226). SF-36 Physical (PCS) and Mental (MCS) Component Summary, and 8 domain scores (physical functioning, role-physical, role-emotional, bodily pain, vitality, social functioning, mental and general health) were evaluated up to W104 and summarized by randomized treatment (i.e. pooled all IV and all SC) from W12-52 among endoscopic improvers at W12 who were rerandomized into maintenance and went onto the extension period. Conclusion: Treatment with miri is associated with a sustained improvement in quality of life as measured by SF-36 from W52 to W104 in patients with moderately-to-severely active CD.Table 1 Observed mean CFBL, (SD) Week 12 Endoscopic Improvers a Week 52 Week 104 Week 52 Week 104 Miri IV-C N=35 Miri IV-C N=29 Miri SC N=41 Miri SC N=38 PCS 10.47 (8.72) 11.68 (6.60) 10.70 (7.88) 9.96 (8.17) MCS 8.49 (11.30) 9.32 (12.35) 11.45 (11.42) 10.43 (11.59) Domain Scores Physical functioning 17.29 (18.48) 19.14 (17.17) 22.93 (22.30) 22.37 (22.83) Role-physical 30.89 (24.95) 32.33 (20.87) 32.01 (28.24) 26.64 (29.27) Role-emotional 13.10 (25.59) 16.95 (26.12) 22.36 (21.36) 19.96 (22.39) Bodily pain 27.20 (29.04) 35.28 (23.86) 34.61 (25.30) 31.00 (27.87) Vitality 28.04 (27.39) 26.72 (29.41) 30.79 (26.16) 29.11 (26.17) Social functioning 29.29 (29.85) 31.90 (24.91) 31.10 (24.71) 25.99 (30.26) Mental health 15.57 (20.39) 17.76 (23.59) 21.83 (23.63) 20.79 (22.74) General health 23.91 (20.38) 26.28 (21.70) 21.02 (18.31) 22.55 (18.38) aEndoscopic improvement: ≥1 point improvement in SES-CD at Week 12.