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Sunday Poster Session

Category: IBD

P0739 - Health-Related Quality of Life From the Inflammatory Bowel Disease Questionnaire in Patients with Ulcerative Colitis Stratified by Prior & Concomitant Therapies: Results From the Etrasimod ELEVATE UC Clinical Program

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
Alessandro Armuzzi, MD, PhD1, David T. Rubin, MD2, Stefan Schreiber, MD3, Julian Panés, MD, PhD4, Marc Fellmann, PhD5, Lauren Bartolome, PharmD, MS6, Martina Goetsch, MD5, Abhishek Bhattacharjee, PhD7, Joseph Wu, PhD8, María Chaparro, MD, PhD9, Marla C. Dubinsky, MD10
1IRCCS Humanitas Research Hospital, Milan, Lombardia, Italy; 2Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; 3University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany; 4Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; 5Pfizer AG, Zurich, Zurich, Switzerland; 6Pfizer Inc., New York, NY; 7Pfizer Healthcare India Pvt. Ltd, Chennai, Tamil Nadu, India; 8Pfizer Inc., Cambridge, MA; 9Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigacíon Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Madrid, Spain; 10Mount Sinai Kravis Children’s Hospital, New York, NY

Introduction: Etrasimod is an investigational, oral, once-daily, selective sphingosine 1‑phosphate (S1P)1,4,5 receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Prior analyses demonstrated etrasimod efficacy in UC1 and greater improvement from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and domains vs placebo (PBO).2

Methods: This post hoc subgroup analysis examined the effect of prior and concomitant therapies on IBDQ scores in the phase 3 ELEVATE UC clinical program. In ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369), eligible patients (pts) with modified Mayo scores of 4–9 completed the 32‑item IBDQ at Weeks (Wks)12 (both trials) and 52 (ELEVATE UC 52). In this analysis, pts were stratified by prior biologic/Janus kinase inhibitor (bio/JAKi) and baseline corticosteroid (CS) use. Least squares (LS) mean change from baseline in IBDQ total and domain scores were compared for etrasimod vs PBO (data as observed). Proportions of pts with IBDQ remission (total score ≥ 170) were analyzed (nonresponder imputation).

Results: Among all randomized patients, there were 304/433 and 236/354 pts without prior bio/JAKi use and 298/433 and 255/354 pts without baseline CS use in ELEVATE UC 52 and ELEVATE UC 12, respectively. Overall, mean baseline IBDQ total scores were similar in pts with and without prior bio/JAKi or baseline CS use. At Wks12 (both trials) and 52 (ELEVATE UC 52), LS mean change from baseline in IBDQ total and domain scores was higher (p < 0.05) for etrasimod vs PBO in pts without prior bio/JAKi and pts without baseline CS use (Table). IBDQ remission was generally achieved by significantly higher proportions of pts receiving etrasimod vs PBO regardless of prior bio/JAKi or baseline CS use at Wk52 (prior bio/JAKi use: No, 46.8% vs 21.2% [p < 0.001] and Yes, 25.0% vs 11.1% [p=0.043]; baseline CS use: No, 41.3% vs 15.7% [p < 0.001] and Yes, 38.7% vs 23.8% [p=0.087]).

Discussion: Pts receiving etrasimod had improvements in IBDQ total score and in all four domains at Wk12, maintained at Wk52. Significant differences were shown in these outcomes with etrasimod vs PBO in pts without prior bio/JAKi and without baseline CS use. IBDQ remission was generally achieved by higher proportions of pts without vs with prior bio/JAKi or without vs with baseline CS use.

References


  1. Sandborn WJ et al. Lancet 2023; 401: 1159-1171.

  2. Armuzzi A et al. J Crohns Colitis 2023: 17; i593–i594.


[n], LS mean change from baseline [a], (SE) Without prior bio/JAKi useWith prior bio/JAKi useWithout baseline CS useWith baseline CS use
Etrasimod
2 mg QD		PBOEtrasimod
2 mg QD		PBOEtrasimod
2 mg QD		PBOEtrasimod
2 mg QD		PBO
ELEVATE UC 52N=205N=99N=84N=45N=196N=102N=93N=42
 Wk12[n=168][n=79][n=64][n=35][n=151][n=77][n=81][n=37]
   IBDQ total score47.44
(2.888)***		27.74
(4.144)		33.98
(5.183)		34.27
(7.099)		41.48
(3.035)**		24.97
(4.185)		44.45
(4.537)		35.51
(6.576)
   Bowel symptoms17.10
(0.941)***		9.55
(1.350)		12.79
(1.645)		12.62
(2.262)		15.39
(0.999)***		8.69
(1.380)		15.60
(1.459)		12.51
(2.113)
   Systemic symptoms6.52
(0.467)***		3.58
(0.670)		4.77
(0.843)		5.21
(1.161)		5.98
(0.475)**		3.52
(0.656)		5.75
(0.773)		4.66
(1.120)
   Emotional health15.77
(1.090)***		9.14
(1.563)		11.34
(1.970)		10.83
(2.697)		13.76
(1.149)**		8.59
(1.583)		15.15
(1.683)		11.10
(2.437)
   Social function8.01
(0.548)**		5.56
(0.785)		5.06
(0.989)		5.47
(1.354)		6.38
(0.589)*		4.28
(0.811)		7.87
(0.842)		7.16
(1.217)
 Wk52 [n=116][n=31] [n=27] [n=10] [n=97][n=24]  [n=46][n=17]
   IBDQ total score58.66
(3.209)**		39.75
(5.611)		47.11
(6.797) 		29.54
(10.705)		55.75
(3.544)***		30.64
(6.563)		51.84
(5.113)		46.70
(7.772)
   Bowel symptoms20.70
(1.057)**		14.17
(1.877)		17.55
(2.217)		11.88
(3.526)		19.79
(1.177)***		11.48
(2.203)		18.70
(1.690)		16.44
(2.591)
   Systemic symptoms7.86
(0.520)*		5.63
(0.912)		5.96
(1.080)		4.24
(1.687)		7.67
(0.550)**		4.13
(1.009)		6.46
(0.891)		6.94
(1.365)
   Emotional health20.25
(1.218)*		14.28
(2.146)		16.03
(2.618)		9.28
(4.144)		19.83
(1.354)**		11.58
(2.530)		16.88
(1.903)		15.46
(2.891)
   Social function10.22
(0.612)**		6.47
(1.074)		7.90
(1.312)		4.85
(2.074)		8.70
(0.683)**		4.12
(1.253)		10.38
(0.974)		8.49
(1.495)
ELEVATE UC 12 N=159N=77 N=79 N=39 N=173  N=82 N=65 N=34
 Wk12 [n=129] [n=64] [n=60][n=31][n=145] [n=67] [n=44][n=28]
   IBDQ total score42.17
(3.321)***		22.29
(4.598)		51.13
(4.408)*		 35.64
(6.038)		 44.85
(2.929)***		24.79
(4.268)		50.71
(5.343)		39.72
(6.596)
   Bowel symptoms16.21
(1.134)***		8.46
(1.565)		18.26
(1.456)		 13.45
(1.996)		 16.85
(1.003)***		9.37
(1.462)		18.37
(1.781)		14.38
(2.197)
   Systemic symptoms5.55
(0.545)**		2.75
(0.756)		6.89
(0.761)		 4.51
(1.043)		 6.02
(0.492)**		3.29
(0.718)		6.94
(0.910)		 4.96
(1.123)
   Emotional health13.66
(1.265)**		7.24
(1.747)		17.25
(1.653)*		 11.11
(2.264)		 14.69
(1.102)***		7.72
(1.605)		16.98
(2.002)		 13.08
(2.478)
   Social function6.81
(0.591)**		3.78
(0.820)		8.66
(0.848)		 6.63
(1.161)		 7.33
(0.526)***		4.30
(0.767)		 8.44
(1.008)		7.29
(1.243) 
[a] For ELEVATE UC 52, estimates are from a mixed-effect model with repeated measures model for change from baseline with a covariate for baseline score, and factors for naive to bio/JAKi therapy (Yes or No, for with or without baseline CS use subgroups only) or baseline CS use (Yes or No, for with or without prior bio/JAKi use subgroups only), baseline disease activity (MMS: 4–6 or 7–9), treatment, visit, and treatment by visit interaction. For ELEVATE UC 12, estimates are from an analysis of covariance model for change from baseline, with a covariate for baseline score, and factors for naive to bio/JAKi therapy (Yes or No, for with or without baseline CS use subgroups only) or baseline CS use (Yes or No, for with or without prior bio/JAKi use subgroups only), baseline disease activity (MMS: 4–6 or 7–9), and treatment

The IBDQ evaluates disease-related quality of life using 32 items examined with four domains: bowel symptoms (score range, 10–70), systemic symptoms (score range, 5–35), emotional health (score range, 12–84) and social function (score range, 5–35). For the total score (range, 32–224) and each domain, a higher score indicates a better quality of life. Responses after intercurrent events and missing responses were considered as nonresponses

*p < 0.05; **p < 0.01; ***p < 0.001. Presented p values are for etrasimod 2 mg once daily vs PBO. p values are presented without adjustment for multiplicity

bio/JAKi, biologic/Janus kinase inhibitor; CS, corticosteroid; IBDQ, Inflammatory Bowel Disease Questionnaire; LS mean, least squares mean; MMS, modified Mayo score; N, total number of pts in the full analysis set; n, number of pts with available IBDQ data at the specified time point; PBO, placebo; pt; patient; QD, once daily; SE, standard error; UC, ulcerative colitis; Wk, week

Table: Table. LS Mean Change from Baseline in IBDQ Total Score and Domains by Prior Bio/JAKi and Baseline CS Use (Full Analysis Set)


Disclosures:
Alessandro Armuzzi: Abbvie – Consultant, Speakers Bureau. Arena – Consultant. Biogen – Grant/Research Support. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant, Speakers Bureau. Celltrion – Consultant. Eli Lilly – Consultant. Ferring Pharmaceuticals – Consultant. Galapagos – Consultant, Speakers Bureau. Gilead Sciences – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Novartis – Speakers Bureau. Pfizer inc – Grant/Research Support. Samsung Bioepis – Consultant, Speakers Bureau. Sandoz – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau.
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.
Stefan Schreiber: AbbVie – Personal fees. Amgen – Personal fees. Arena Pharmaceuticals – Personal fees. Biogen – Personal fees. Bristol Myers Squibb – Personal fees. Celgene – Personal fees. Celltrion Healthcare – Personal fees. Dr. Falk Pharma – Personal fees. Eli Lilly – personal fees. Ferring Pharmaceuticals – personal fees. Fresenius Kabi – Personal fees. Galapagos – Personal fees. Gilead – Personal fees. Hikma Pharmaceuticals – Personal fees. I-Mab – Personal fees. Janssen Pharmaceuticals – Personal fees. Morphic – Personal fees. MSD – Personal fees. Mylan – Personal fees. Pfizer – Personal fees. Protagonist – Personal fees. ProventionBio – Personal fees. Sandoz/Hexal – personal fees. Takeda – Personal fees. Theravance Biopharma – Personal fees. UCB – personal fees.
Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Consultant. Athos – Consultant. Atomwise – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant. Genentech/Roche – Consultant. GlaxoSmithKline – Consultant. Immunic – Personal fees. Janssen – Consultant, payment for development of educational presentations. Mirum – Consultant. Morphic – Consultant. Origo – Consultant. Pandion – Consultant. Pfizer Inc – Grant/Research Support, payment for development of educational presentations. Progenity – Consultant. Revolo – Consultant. Takeda – payment for development of educational presentations. Theravance – Consultant. Wasserman – Consultant.
Marc Fellmann: Pfizer AG – Employee. Pfizer Inc – Stock-publicly held company(excluding mutual/index funds).
Lauren Bartolome: Pfizer Inc – Employee, Stock Options.
Martina Goetsch: Pfizer AG – Employee. Pfizer Inc – Stock-publicly held company(excluding mutual/index funds).
Abhishek Bhattacharjee: Pfizer Healthcare India – Employee. Pfizer Inc – Stock Options.
Joseph Wu: Pfizer Inc – Employee, Stock Options.
María Chaparro: Gilead – Consultant. Janssen – Consultant. Lilly – Consultant. Pfizer Inc – Consultant. Takeda – Consultant. Tillots – Consultant.
Marla Dubinsky: AbbVie – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant. Astra Zeneca – Consultant. Celgene – Consultant. Genentech Inc. – Consultant. Gilead Sciences – Consultant. Janssen – Consultant, Grant/Research Support. Merck – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus Biosciences – Consultant, Grant/Research Support. Prometheus Labs – Consultant, Grant/Research Support. Takeda – Consultant, Licensing fees. Thabor – Consultant. Trellus Health – Stock-publicly held company(excluding mutual/index funds). UCB Pharma – Consultant.


Alessandro Armuzzi, MD, PhD1, David T. Rubin, MD2, Stefan Schreiber, MD3, Julian Panés, MD, PhD4, Marc Fellmann, PhD5, Lauren Bartolome, PharmD, MS6, Martina Goetsch, MD5, Abhishek Bhattacharjee, PhD7, Joseph Wu, PhD8, María Chaparro, MD, PhD9, Marla C. Dubinsky, MD10. P0739 - Health-Related Quality of Life From the Inflammatory Bowel Disease Questionnaire in Patients with Ulcerative Colitis Stratified by Prior & Concomitant Therapies: Results From the Etrasimod ELEVATE UC Clinical Program, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.