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Sunday Poster Session

Category: IBD

P0733 - Mirikizumab Sustains Improvement on Health-Related Quality of Life in Patients With Crohn’s Disease at Week 104: A Phase 2 Study Analysis Using the SF-36

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
David T. Rubin, MD1, Toshifumi Hibi, MD, PhD2, Theresa Hunter Gibble, PhD, MPH3, Lai Shan Chan, MS3, Zhantao Lin, 3, Marijana Protic, MD, PhD3, Vipul Jairath, MBChB, DPhil4
1Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; 2Kitasato University, Minato City, Tokyo, Japan; 3Eli Lilly and Company, Indianapolis, IN; 4Western University, London, ON, Canada

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). Here we evaluated the effect of miri on quality of life up to W104.

Methods: Patients (N=191) were randomized 2:1:1:2 allocation across 4 treatment arms (PBO, 200, 600, and 1000mg miri, administered intravenously (IV) every 4 weeks (Q4W) at W0, W4, and W8). Patients who received miri and achieved ≥1 point improvement in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at W12 (Improvers) were rerandomized 1:1 into double-blind maintenance to either continue IV treatment assignment Q4W (IV-C) or to 300mg miri subcutaneous (SC) Q4W (IV-SC) up to W52. Subjects with clinical benefit from the maintenance period received 300mg SC Q4W from W52-W104 (open-label extension period). 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.


Results: Of the 127 patients randomized to miri for induction, 68.5% (87/127) achieved endoscopic improvement at W12 and were rerandomized into maintenance. Of the 87 W12 endoscopic improvers, 74 finished W52 maintenance and entered the extension period (W52-W104) where 68 went on to complete treatment through W104. Although statistical comparisons were not made between groups during the maintenance and extension periods, comparison of mean changes from baseline in PCS, MCS, and domain scores suggest that improvements at W52 were sustained or further numerically increased with miri extension treatment (W52-W104) in the IV-C group. PCS, MCS, and domain scores are reported in Table 1.

Discussion: 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.
Observed mean CFBL, (SD)Week 12 Endoscopic Improvers a
Week 52Week 104Week 52Week 104
Miri IV-C
N=35		Miri IV-C
N=29		Miri SC
N=41		Miri SC
N=38
PCS10.47 (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-emotional13.10 (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)

Table: Footnotes:
a Endoscopic improvement: ≥1 point improvement in SES-CD at Week 12.
Abbreviations: CFBL = change from baseline; SD = standard deviation; PCS = Physical Component Summary; MCS = Mental Component Summary; IV-C = all IV-IV miri groups pooled; SC = all IV-subcutaneous miri groups pooled


Disclosures:
David Rubin: AbbVie – Consultant, personal fees. AltruBio – Consultant, personal fees. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Corp/Syneos – Consultant. Eco R1 – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, personal fees. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant, personal fees. Kaleido Biosciences – Consultant. Lilly – Consultant. Pfizer – Consultant, personal fees. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant, personal fees. Seres Therapeutics – Consultant. Takeda – Consultant, Grant/Research Support, Personal fees. Target RWE – Consultant. Trellus Health – Consultant.
Toshifumi Hibi: AbbVie GK – Consultant, Grant/Research Support, Speakers Bureau. Activaid – Grant/Research Support. Alfresa Pharma – Grant/Research Support. Apo Puls Station – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Grant/Research Support. Celltrion – Advisory Committee/Board Member, Consultant. EA Pharma – Advisory Committee/Board Member, Consultant, Study group sponorship. Eli Lilly and Company – Advisory Committee/Board Member, Consultant. Ferring – Grant/Research Support, Speakers Bureau. Gilead Sciences – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. JIMRO – Study group sponorship, Speakers Bureau. JMDC Inc – Grant/Research Support. Kyorin – Advisory Committee/Board Member, Consultant, Study group sponsorship. Mitsubishi-TanabePharma – Advisory Committee/Board Member, Consultant, Scholarship contributions, Speakers Bureau. Mochida Pharmaceutical – Grant/Research Support, Study group sponorship, Speakers Bureau. Nichi-Iko Pharmaceutical – Advisory Committee/Board Member, Consultant. Nippon Kayaku Co – Grant/Research Support, Scholarship contributions. Otsuka Holdings – Study group sponsorship. Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Pfizer Japan Inc – Grant/Research Support. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Zeria Pharmaceutical – Advisory Committee/Board Member, Consultant, Scholarship contributions and study group sponsorship.
Theresa Hunter Gibble: Eli Lilly and Company – Employee, stockholder.
Lai Shan Chan: Eli Lilly and Company – Employee, Shareholder.
Zhantao Lin: Eli Lilly and Company – Employee.
Marijana Protic: Eli Lilly and Company – Employee.
Vipul Jairath: AbbVie – Advisory Committee/Board Member, consulting/advisory board fees, speaker’s fees. Alimentiv Inc – consulting/advisory board fees. Arena pharmaceuticals – consulting/advisory board fees. Asahi Kasei Pharma – consulting/advisory board fees. Asieris – consulting/advisory board fees. Astra Zeneca – consulting/advisory board fees. Bristol Myers Squibb – consulting/advisory board fees, speaker’s fees. Celltrion – consulting/advisory board fees. Eli Lilly and Company – consulting/advisory board fees. Ferring – consulting/advisory board fees, speaker’s fees. Flagship Pioneering – consulting/advisory board fees. Fresenius Kabi – consulting/advisory board fees, speaker’s fees. Galapagos – consulting/advisory board fees, speaker’s fees. Genentech – consulting/advisory board fees. Gilead – consulting/advisory board fees. GlaxoSmithKline – consulting/advisory board fees. Janssen – consulting/advisory board fees, speaker’s fees. Merck – consulting/advisory board fees. Metacrine – consulting/advisory board fees. Mylan – consulting/advisory board fees. Pandion – consulting/advisory board fees. Pendopharm – consulting/advisory board fees. Pfizer – consulting/advisory board fees, speaker’s fees. Prometheus – consulting/advisory board fees. Protagonist – consulting/advisory board fees. Reistone Biopharma – consulting/advisory board fees. Roche – consulting/advisory board fees. Sandoz – consulting/advisory board fees. Second Genome – consulting/advisory board fees. Shire – speaker’s fees. Sorriso pharmaceuticals – consulting/advisory board fees. Takeda – consulting/advisory board fees, speaker’s fees. Teva – consulting/advisory board fees. Topivert – consulting/advisory board fees. Ventyx – consulting/advisory board fees. Vividion – consulting/advisory board fees.


David T. Rubin, MD1, Toshifumi Hibi, MD, PhD2, Theresa Hunter Gibble, PhD, MPH3, Lai Shan Chan, MS3, Zhantao Lin, 3, Marijana Protic, MD, PhD3, Vipul Jairath, MBChB, DPhil4. P0733 - Mirikizumab Sustains Improvement on Health-Related Quality of Life in Patients With Crohn’s Disease at Week 104: A Phase 2 Study Analysis Using the SF-36, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.