P0731 - PRA023 Improved Health-Related Quality of Life as Measured by IBDQ-32 in a Phase 2 Trial in Patients with Moderately to Severely Active Ulcerative Colitis

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

David Rubin, MD, FACG

University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL

David T. Rubin, MD, FACG¹, Bruce E. Sands, MD, MS, FACG², Laurent Peyrin-Biroulet, MD, PhD³, Silvio Danese, MD, PhD⁴, Deanna D.. Nguyen, MD⁵, Quinn Dinh, MD⁵, Bin Dong, ⁵, Christopher Ma, MD⁶, Timothy E.. Ritter, MD⁷, Remo Panaccione, MD⁸
¹University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France; ⁴IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy; ⁵Prometheus Biosciences, Inc., San Diego, CA; ⁶Alimentiv Inc., University of Calgary, London, ON, Canada; ⁷GI Alliance, Southlake, TX; ⁸University of Calgary, Calgary, AB, Canada

Introduction: PRA023 is a humanized monoclonal antibody against tumor necrosis factor–like cytokine 1A (TL1A) in development for inflammatory bowel diseases. In ARTEMIS-UC, a phase 2, double-blind, placebo-controlled study of PRA023 in adults with moderately to severely active ulcerative colitis (UC), a significantly greater proportion of patients receiving PRA023 achieved clinical remission. This post hoc analysis assessed the impact of PRA023 on health-related quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ-32).

Methods: Adults with a modified Mayo score of 4 to 9, centrally read endoscopy subscore of ≥2, rectal bleeding subscore of ≥1, and history of insufficient response, loss of response, and/or intolerance to conventional and/or advanced therapies were stratified by prior biologic exposure and genetic-based diagnostic status and randomized 1:1 to placebo or intravenous PRA023 (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). IBDQ outcomes measures include IBDQ response (score of ≥16 points from baseline), IBDQ remission (total score ≥170), and mean change from baseline in total and domain scores after 12 weeks of induction therapy. Score changes from baseline were compared between treatment groups, and the impact of prior advanced therapy exposure on IBDQ remission was assessed.

Results: Of 135 patients enrolled, 60/67 (89.6%) in the placebo arm and 68/68 (100%) in the PRA023 arm completed the 12-week induction period. Baseline characteristics were similar between the treatment groups. Significantly greater proportions of patients in the PRA023 group achieved IBDQ response (82.4% PRA023 vs 49.3% placebo, ∆33.1%, p< 0.0001) and IBDQ remission (51.5% PRA023 vs 19.4% placebo, ∆32.1%, p=0.0001) at week 12. Prior advanced therapy use did not affect the placebo-adjusted proportion of patients experiencing IBDQ remission in those who received PRA023 (Δ34.4% vs Δ30.0%, respectively, for prior and no prior advanced therapy). The total IBDQ score and all IBDQ domain subscores (bowel symptoms, systemic symptoms, emotional function, and social function) were significantly improved after 12 weeks of PRA023 induction treatment compared to placebo (Table 1).

Discussion: PRA023 significantly improved quality-of-life measures in patients with moderately to severely active UC, regardless of prior advanced therapy use. The greatest benefits were reported in the bowel symptoms and emotional function domains.

IBDQ outcomes	Placebo	PRA023	% Difference vs placebo (95% CI)	p value
IBDQ response (%, n/N)†‡	49.3 (33/67)	82.4 (56/68)	33.1 (17.2–46.8)	< 0.0001
IBDQ remission (%, n/N)‡	19.4 (13/67)	51.5 (35/68)	32.1 (16.0–45.9)	0.0001
Prior advanced therapy	18.8 (6/32)	53.1 (17/32)	34.4 (10.9–53.1)	-
No prior advanced therapy	20.0 (7/35)	50.0 (18/36)	30.0 (7.8–48.4)	-
Change in IBDQ scores from BL, mean±SD
Total score	20.8±37.59	48.6±34.85	26.8 (14.6–38.9)	< 0.0001
Bowel symptoms subscore	7.1±12.27	17.2±11.79	9.4 (5.3–13.4)	< 0.0001
Systemic symptoms subscore	3.0±5.97	7.0±6.56	4.0 (2.0–6.0)	0.0002
Emotional function subscore	6.6±14.59	16.1±13.25	8.9 (4.3–13.5)	0.0002
Social function subscore	4.1±7.74	8.2±7.38	4.4 (2.0–6.8)	0.0004

Table: Table 1. IBDQ Outcomes with PRA023 Induction Therapy
†Prespecified secondary endpoint.
‡Nonresponder imputation was applied to response and remission endpoints.
Abbreviations: BL, baseline; IBDQ, Inflammatory Bowel Disease Questionnaire.
p values are nominal except IBDQ response.

Disclosures:

David T. Rubin: AbbVie – Consultant. Alike Health – Stock Options. AltruBio – Consultant, Stock Options. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Cornerstones Health, Inc – Advisory Committee/Board Member. Crohn's & Colitis Foundation – Advisory Committee/Board Member. Datos Health – Stock Options. EcoR1 – Consultant. Eli Lilly – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Iterative Health – Stock Options. Janssen – Consultant. Kaleido Biosciences – Consultant. Pfizer – Consultant. Prometheus Biosciences – Consultant. Reistone – Consultant. Seres Therapeutics – Consultant. Syneos – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Trellus Health – Consultant.

Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speaker’s fees. Adiso Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena pharmaceuticals – Consultant. Artizan Biosciences – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Bacainn Therapeutics – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees and other support. Calibr – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Connect Biopharm – Consultant. Cytoki Pharma – Consultant. Eli Lilly – Consultant, speaking fees and other support. Enthera – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. HMP Acquisition – Consultant. Imhotex – Consultant. Immunic – Consultant. InDex Pharmaceuticals – Consultant. Innovation Therapeutics – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Grant/Research Support, consulting and speaking fees and other support. Johnson & Johnson – Consultant. Kaleido Biosciences – Consultant. Kallyope – Consultant. Merck – Consultant. MiroBio – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. OSE Immunotherapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, speaking fees and other support. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. RedHill Biopharma – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Synlogic Operating Company – Consultant. Takeda – Grant/Research Support, consulting and speaking fees and other support. Target RWE – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. USWM Enterprises – Consultant. Ventyx Biosciences – Consultant, personal fees and stock options for consulting. Viela Bio – Consultant.

Laurent Peyrin-Biroulet: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Allergan – personal fees. Alma – personal fees. Amgen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Applied Molecular Transport – personal fees. Arena – personal fees. Biogaran – Advisory Committee/Board Member, Consultant, Speakers Bureau. Biogen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant, Speakers Bureau. Bristol Myers Squibb – personal fees. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. CTMA – Stock Options. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Enterome – personal fees. Enthera – personal fees. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Forward Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Fresenius – personal fees. Genentech – Advisory Committee/Board Member, Consultant, Speakers Bureau. Gilead – personal fees. H.A.C. Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Hikma – personal fees. Hospira/Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Index Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Lycera – Advisory Committee/Board Member, Consultant, Speakers Bureau. Merck – Advisory Committee/Board Member, Consultant, Speakers Bureau. Mitsubishi – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Grant/Research Support, personal fees. Mylan – personal fees. Nestlé – personal fees. Norgine – Advisory Committee/Board Member, Consultant, Speakers Bureau. Oppilan Pharma – personal fees. OSE Immunotherapeutics – personal fees. Pfizer – personal fees. Pharmacosmos – personal fees. Roche – personal fees. Samsung Bioepis – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sterna – personal fees. Sublimity Therapeutics – personal fees. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant, Speakers Bureau. Tillots – Advisory Committee/Board Member, Consultant, Speakers Bureau. Vifor – Advisory Committee/Board Member, Consultant, Speakers Bureau.

Silvio Danese: AbbVie – Consultant, personal fees (lecture fees). Alimentiv – Consultant. Allergan – Consultant, personal fees. Amgen – Consultant, lecture fees. Applied Molecular Transport – Consultant. AstraZeneca – Consultant, personal fees. Athos Therapeutics – Consultant, personal fees. Biogen – Consultant, personal fees. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene – Consultant, personal fees. Celltrion Healthcare – Consultant, Personal fees. Dr Falk Pharma – Consultant. Eli Lilly – Consultant, personal fees. Enthera – Consultant, personal fees. Ferring Pharmaceuticals – Consultant, lecture fees. Gilead – Consultant, lecture fees. Hospira – Consultant, personal fees. Inotrem – Consultant, personal fees. Janssen Pharmaceuticals – Consultant, lecture fees. Johnson & Johnson – Consultant, personal fees. Morphic – Consultant. MSD – Consultant, personal fees. Mundipharma – Consultant, personal fees. Mylan – Consultant, lecture fees. Pfizer – Consultant, lecture fees. Roche – Consultant, personal fees. Sandoz – Consultant, personal fees. Sublimity Therapeutics – Consultant, personal fees. Takeda – Consultant, lecture fees. Teladoc Health – Consultant. TiGenix – Consultant, personal fees. UCB – Consultant, personal fees. Vial – Consultant. Vifor – Consultant, personal fees.

Deanna Nguyen: Prometheus Biosciences – Employee.

Quinn Dinh: Prometheus Biosciences – Employee, Stock-publicly held company(excluding mutual/index funds).

Bin Dong: Prometheus Biosciences – Employee.

Christopher Ma: AbbVie – Consultant, Speakers Bureau. Alimentiv – Consultant, Speakers Bureau. Amgen – Consultant, Speakers Bureau. AVIR Pharma Inc – Consultant, Speakers Bureau. BioJAMP – Consultant. Bristol Myers Squibb – Consultant, Speakers Bureau. Celltrion – Consultant. Ferring – Consultant, Grant/Research Support, Speakers Bureau. Fresenius Kabi – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. McKesson – Consultant. Mylan – Consultant. Pendopharm – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Prometheus Biosciences Inc. – Consultant. Roche – Consultant. Sanofi – Consultant. Springer Publishing – Royalties. Takeda – Consultant, Speakers Bureau.

Timothy Ritter: Abbvie – Advisory Committee/Board Member, Speakers Bureau. ArdelyxArena – Advisory Committee/Board Member. Boehringer Ingelheim – Advisory Committee/Board Member. Bristol-Myers Squibb – Advisory Committee/Board Member, Speakers Bureau. Celgene – Advisory Committee/Board Member. Ferring – Advisory Committee/Board Member. Genentech/Roche Gilead – Advisory Committee/Board Member. Intercept – Advisory Committee/Board Member. Iterative Scopes – Advisory Committee/Board Member, Stock-publicly held company(excluding mutual/index funds). Janssen – Advisory Committee/Board Member, Speakers Bureau. Lilly – Advisory Committee/Board Member. Pfizer inc – Advisory Committee/Board Member, Speakers Bureau. Prometheus Biosciences – Advisory Committee/Board Member. Sanofi – Advisory Committee/Board Member. Takeda – Advisory Committee/Board Member, Speakers Bureau.

Remo Panaccione: Abbivax – Consultant. Abbott – Consultant. AbbVie – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena – Consultant. AstraZeneca – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion – Consultant. Cosmos Technology – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. JAMP Bio – Consultant. Janssen – Consultant. Merck – Consultant. Mylan – Consultant. Novartis – Consultant. Oppilan Pharma – Consultant. Organon – Consultant. Pandion Pharma – Consultant. Pendopharm – Consultant. Pfizer Inc – Consultant. Progenity – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant. Sandoz – Consultant. Satisfai Health – Consultant. Shire – Consultant. Sublimity Therapeutics – Consultant. Takeda Pharmaceuticals – Consultant. Theravance Biopharma – Consultant. Trellus – Consultant. UCB – Consultant. Ventyx – Consultant. Viatris – Consultant.

David T. Rubin, MD, FACG¹, Bruce E. Sands, MD, MS, FACG², Laurent Peyrin-Biroulet, MD, PhD³, Silvio Danese, MD, PhD⁴, Deanna D.. Nguyen, MD⁵, Quinn Dinh, MD⁵, Bin Dong, ⁵, Christopher Ma, MD⁶, Timothy E.. Ritter, MD⁷, Remo Panaccione, MD⁸. P0731 - PRA023 Improved Health-Related Quality of Life as Measured by IBDQ-32 in a Phase 2 Trial in Patients with Moderately to Severely Active Ulcerative Colitis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.