B0367 - Health-Related Quality of Life with Guselkumab Induction and Maintenance Therapy as Measured by PROMIS-29: Results Through Week 48 of Phase 2 GALAXI 1 Study

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

David T. Rubin, MD, FACG

University of Chicago Medicine Inflammatory Bowel Disease Center
Chicago, IL

David T. Rubin, MD, FACG¹, Bruce E. Sands, MD, MS, FACG², Remo Panaccione, MD³, Chenglong Han, PhD⁴, Kathleen Weisel, MS⁵, Mary Ellen Frustaci, MS⁵, Zijiang Yang, MS⁵, Aparna Sahoo, MD⁵, Anita Afzali, MD, MPH, FACG⁶, Jane Andrews, MD⁷, Silvio Danese, MD, PhD⁸, Tadakazu Hisamatsu, MD, PhD⁹, Brian G. Feagan, MD¹⁰, Julian Panés, MD¹¹, Walter Reinisch, MD, PhD¹², William J. Sandborn, MD¹³, Geert D’Haens, MD, PhD¹⁴
¹University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³University of Calgary, Calgary, AB, Canada; ⁴Janssen Global Services, LLC, Malvern, PA; ⁵Janssen Research & Development, LLC, Spring House, PA; ⁶The Ohio State University Wexner Medical Center, Columbus, OH; ⁷Royal Adelaide Hospital & University of Adelaide, Adelaide, South Australia, Australia; ⁸IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Molise, Italy; ⁹Kyorin University School of Medicine, Tokyo, Tokyo, Japan; ¹⁰Alimentiv, Inc.; Western University, London, ON, Canada; ¹¹Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; ¹²Medical University of Vienna, Vienna, Wien, Austria; ¹³University of California San Diego, La Jolla, CA; ¹⁴Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands

Introduction: Patients (pts) with Crohn’s disease (CD) suffer from symptoms that negatively impact their health related quality of life (HRQoL). In GALAXI 1, a phase 2 study of guselkumab (GUS), a selective IL-23 antagonist, for the treatment of pts with moderately to severely active CD who had inadequate response or intolerance to conventional therapies and/or biologics, HRQoL was evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29.

Methods: GALAXI has a treat-through design with pts remaining on randomized treatment (GUS or ustekinumab [UST]) through Wk48. Pts were randomized 1:1:1:1:1 into 5 arms for induction: GUS 200, 600, or 1200mg IV at Weeks (Wks) 0, 4, 8; UST ~6mg/kg IV at Wk0 and 90mg SC at Wk8; or PBO IV. At Wk12, pts transitioned to maintenance: GUS 200mg IVà100mg SC q8w, GUS 600mg IVà200mg SC q4w, GUS 1200mg IVà200mg SC q4w, PBO non-respondersàUST ~6mg/kg IVà90mg SC q8w, and PBO respondersàPBO SC q4w. UST pts continued 90mg SC q8w. Pts randomized to PBO were not included in the Wk48 analyses.

PROMIS-29 consists of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social participation) and a pain intensity 0-10 numeric rating scale (NRS). The raw score of each domain is converted into a standardized T-score with a general population mean of 50 and standard deviation (SD) of 10. For physical function and social participation, higher scores indicate better outcomes, while for all other symptom domains like anxiety, higher scores indicate worse outcomes. Clinically meaningful improvement was defined as ≥3-point improvement in pain NRS score and ≥5-point (or 1/2 SD of population) improvement in each domain T-score.

Results: Among pts randomized and evaluated in the primary efficacy analysis, mean PROMIS-29 domain scores were similar between treatment groups at baseline with functional domain score < 50 and symptom domain scores >50, indicating impaired HRQoL (Table). Pts treated with GUS had greater improvement in all domain scores at Wk12 compared with PBO. GUS treatment resulted in continued improvement in domain scores from Wk12 to Wk48. GUS-treated pts achieved clinically meaningful improvement in fatigue T-scores (45.9-63.5%), pain interference T-scores (52.5-71.4%) and pain intensity NRS score at Wk48 (56.4-70.2%).

Discussion: Induction and maintenance treatment with GUS was effective in improving HRQoL as measured by PROMIS-29 in pts with moderately to severely active CD at Wk48.

Nominal p-value < 0.05 for guselkumab vs placebo at Wk 12. *Nominal p-value < 0.001 for guselkumab vs placebo at Wk 12. ^aPatients who had a prohibited change in concomitant Crohn’s disease medication, a Crohn’s disease-related surgery, or discontinued study agent due to lack of efficacy or an AE of worsening Crohn’s disease prior to the designated analysis timepoint had their baseline value carried forward from that timepoint onwards. Patients who had discontinued study agent due to any other reasons prior to the designated analysis timepoint had their observed data used, if available, from that timepoint onwards. ^bPatients who had insufficient data to calculate PROMIS-29 domain score at the designated analysis timepoint did not have their missing data imputed. NOTE: No comparisons between ustekinumab and placebo were made at Wk 12. No treatment comparisons were made at Wk 48. The p-values for the comparisons of each guselkumab treatment group with the placebo group at Wk 12 were based on MMRM analysis including change from baseline in PROMIS-29 domain score as the response; treatment group, visit, baseline PROMIS-29 domain score, BIO-Failure status (yes, no), baseline CDAI stratification (≤300, >300), an interaction term of visit with treatment group and an interaction term of visit with baseline PROMIS-29 domain score as explanatory variables.
	Placebo (N=61)	GUS 200 mg IV q4w à100 mg SC q8w (N=61)	GUS 600 mg IV q4w à200 mg SC q4w (N=63)	GUS 1200 mg IV q4w à 200 mg SC q4w (N=61)	UST ~6 mg/kg IV à90 mg SC q8w (N=63)
Anxiety T-score^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	57.68 (10.004), N=57 -0.73 (8.872), N=56	56.43 (9.344), N=60 -4.63 (8.869),* N=58 -5.66 (10.437), N=56	56.94 (9.843), N=63 -3.43 (9.178),* N=61 -4.85 (8.831), N=58	57.29 (9.455), N=61 -6.78 (7.805),** N=57 -6.34 (10.188), N=49	54.25 (9.068), N=63 -3.86 (7.908), N=63 -5.09 (6.624), N=59
Depression T-score ^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	54.99 (9.386), N=57 -0.17 (8.384), N=56	54.33 (9.306), N=60 -4.54 (10.567),** N=58 -4.91 (11.899), N=56	53.64 (10.567), N=63 -1.98 (7.123),* N=61 -3.33 (8.077), N=58	54.07 (9.499), N=61 -5.48 (6.999),** N=57 -5.52 (9.559), N=49	52.20 (8.619), N=63 -3.70 (8.217), N=63 -2.86 (7.055), N=59
Fatigue T-score^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	57.80 (9.128), N=57 -0.89 (9.640), N=56	56.36 (9.193), N=60 -7.33 (9.320),** N=58 -7.59 (10.587), N=56	56.74 (10.097), N=63 -6.30 (9.314)**, N=61 -9.53 (9.903), N=58	58.35 (9.361), N=61 -7.27 (8.021),** N=57 -8.03 (9.114), N=49	56.03 (8.991), N=63 -5.91 (10.467), N=63 -7.44 (9.369), N=59
Pain interference T-score ^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	62.25 (6.625), N=57 -2.43 (7.811), N=56	60.26 (8.550), N=60 -8.19 (9.467),** N=58 -10.71 (10.989), N=56	62.26 (6.337), N=63 -9.29 (8.997),** N=61 -13.44 (9.060), N=58	60.69 (7.418), N=61 -6.60 (7.659),** N=57 -10.34 (9.568), N=49	60.37 (8.431), N=63 -7.93 (9.854), N=63 -7.70 (9.334), N=59
Pain intensity NRS score, ^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	5.53 (2.122), N=57 -0.84 (2.380), N=56	5.13 (2.012), N=60 -2.41 (2.740),** N=58 -3.11 (2.695), N=56	5.49 (1.925), N=63 -2.82 (2.164),** N=61 -3.53 (2.494), N=58	5.46 (2.038), N=61 -2.30 (2.420),** N=57 -2.88 (2.990), N=49	5.37 (2.238), N=63 -2.21 (2.259), N=63 -2.73 (2.420), N=59
Physical Function T-score ^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	42.70 (7.491), N=57 1.24 (8.106), N=56	44.71 (8.391), N=60 4.64 (8.249),* N=58 5.98 (8.851), N=56	45.24 (7.888), N=63 3.73 (7.053),* N=61 5.73 (8.242), N=58	43.16 (8.275), N=61 3.40 (8.037),* N=57 5.18 (8.243), N=49	45.72 (8.056), N=63 3.30 (7.888), N=63 3.80 (7.307), N=59
Sleep disturbance T-score^{a ,b} Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	55.06 (8.418), N=57 -0.88 (6.833), N=56	54.19 (8.062), N=60 -4.83 (8.489),** N=58 -5.36 (8.520), N=56	54.84 (7.181), N=63 -4.05 (5.805),* N=61 -6.28 (7.636), N=58	53.23 (7.447), N=61 -4.02 (5.727),** N=57 -5.48 (7.018), N=49	52.55 (7.408), N=63 -3.16 (8.143), N=63 -4.61 (7.580), N=59
Ability to participate in social roles and activities T-score ^a,b Baseline, mean (SD) Change from baseline, mean (SD), at: Wk 12 Wk 48	45.50 (7.990), N=57 0.58 (7.962), N=56	46.25 (9.278), N=60 6.54 (8.867),** N=58 7.65 (10.842), N=56	46.80 (8.705), N=63 5.18 (8.922),** N=61 8.56 (9.877), N=58	45.40 (9.329), N=61 5.49 (7.130),** N=57 7.10 (8.142), N=49	47.99 (8.827), N=63 4.81 (8.364), N=63 5.44 (8.757), N=59

Table: Table 1. Change from baseline at Wk 12 and Wk 48 for PROMIS-29 scores

Disclosures:

David Rubin: AbbVie – Consultant. Alimentiv Inc. – Consultant. AltruBio – Consultant. Arena Pharmaceuticals – Consultant. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim, Ltd. – Consultant. Bristol Myers Squibb – Consultant. Celgene Corp/Syneos – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. EcoR1 – Consultant. Genentech/Roche – Consultant. Gilead Sciences – Consultant. Ironwood Pharmaceuticals – Consultant. Iterative Scopes – Consultant. Janssen – Consultant. Kaleido Biosciences – Consultant. Lilly, Eli & Co – Consultant. Materia Prima – Consultant. Pfizer – Consultant. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant. Seres Therapeutics, Inc – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Techlab – Consultant. Trellus Health – Consultant.

Bruce Sands: Abivax – Consultant, Speaking. Amgen – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Bacainn Therapeutics – Consultant. Boehringer-Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, speaking, research funding. Calibr – Consultant. Celltrion Healthcare – Consultant. ClostraBio – Consultant. Eli Lilly and Company – Consultant. Entera – Consultant. Evommune – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. InDex Pharmaceuticals – Consultant. Innovation Therapeutics – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Consultant, Grant/Research Support, speaking. Kaleido – Consultant. Kallyope – Consultant. Miro Bio – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. Pfizer – Consultant, speaking. Progenity – Consultant. Prometheus Biosciences – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. Surrozen – Consultant. Takeda – Consultant, Speaking. Teva – Consultant. TLL Pharmaceutical – Consultant. USWM Enterprises – Consultant. VielaBio – Consultant.

Remo Panaccione: Abbott – Consultant. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Alimentiv – Consultant. Amgen – Advisory Committee/Board Member, Consultant. Arena – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant. Cosmos Pharmaceuticals – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead Sciences – Advisory Committee/Board Member, Consultant, Speakers Bureau. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Merck – Advisory Committee/Board Member, Consultant, Speakers Bureau. Mylan – Advisory Committee/Board Member, Consultant. Oppilan Pharma – Advisory Committee/Board Member, Consultant. Pandion Pharma – Advisory Committee/Board Member. Pandion Therapeutics – Consultant. Pfizer – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Progenity – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Satisfai Health – Consultant. Schering-Plough – Consultant. Shire – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sublimity Therapeutics – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant. UCB – Consultant.

Chenglong Han: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds).

Kathleen Weisel: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds).

Mary Ellen Frustaci: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds).

Zijiang Yang: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds).

Aparna Sahoo: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds).

Anita Afzali: AbbVie – Consultant, Speakers Bureau. Bristol Myers Squibb – Consultant, Speakers Bureau. DiaSorin – Consultant. Eli Lilly – Consultant. Gilead – Consultant. Janssen – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau. TLL Pharmaceuticals – Consultant.

Jane Andrews: AbbVie – Consultant, Grant/Research Support. Dr Falk Pharma – Consultant, Grant/Research Support. Janssen Research & Development, LLC – Consultant, Grant/Research Support.

Silvio Danese: AbbVie – Consultant, Speakers Bureau. Allergan – Consultant, Speakers Bureau. Amgen – Consultant, Speakers Bureau. AstraZeneca – Consultant, Speakers Bureau. Athos Therapeutics – Consultant, Speakers Bureau. Biogen – Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant, Speakers Bureau. Celgene – Consultant, Speakers Bureau. Celltrion – Consultant, Speakers Bureau. Eli Lilly – Consultant, Speakers Bureau. Enthera – Consultant, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Gilead – Consultant, Speakers Bureau. Hospira – Consultant, Speakers Bureau. Inotrem – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. Johnson & Johnson – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Mundipharma – Consultant, Speakers Bureau. Mylan – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Roche – Consultant, Speakers Bureau. Sandoz – Consultant, Speakers Bureau. Sublimity Therapeutics – Consultant, Speakers Bureau. Takeda – Consultant, Lecture fees. TiGenix – Consultant, Speakers Bureau. UCB Inc – Consultant, Speakers Bureau. Vifor – Consultant, Speakers Bureau.

Tadakazu Hisamatsu: AbbVie – Consultant, Grant/Research Support, Lecture fees. Celgene – Consultant. Daiichi-Sankyo – Grant/Research Support. EA Pharma Co, Ltd – Consultant, Grant/Research Support, Lecture fees. Janssen Research & Development, LLC – Consultant, lecture fees. JIMRO – Grant/Research Support. JIMRO Co – Consultant, Grant/Research Support. Kyorin Pharmaceutical Co. Ltd – Consultant, Grant/Research Support. Mitsubishi Tanabe Pharma Corporation – Grant/Research Support, Lecture fees. Mochida Pharmaceutical Co., Ltd – Grant/Research Support, lecture fees. Nichi-Iko Pharmaceutical Co., Ltd – Consultant. Nippon Kayaku Co., Ltd – Grant/Research Support. Pfizer Inc – Consultant, Grant/Research Support, lecture fees. Takeda Pharmaceutical Co., Ltd – Grant/Research Support, Lecture fees. Zeria Pharmaceutical Co. Ltd – Grant/Research Support.

Brian Feagan: AbbVie – Consultant, Member of the scientific advisory board, Speakers Bureau. AbolerIS – Consultant. AgomAB Therapeutics – Consultant. Alimentiv Inc – Employee. Allianthera – Consultant. Amgen – Consultant, Member of the scientific advisory board. AnaptysBio – Consultant. Applied Molecular Transport Inc. – Consultant. Arena Pharma – Consultant. Avir – Consultant. Azora Therapeutics – Consultant. BioJamp – Consultant. Biopharma – Consultant. Biora Therapeutics – Consultant. Boehringer-Ingelheim – Consultant, Member of scientific advisory board. Boston Pharma – Consultant. Boxer – Consultant. Celgene/BMS – Consultant, Member of scientific advisory board. Connect BioPharma – Consultant. Cytoki – Consultant. Disc Medicine – Consultant. Duality – Consultant. EcoR1 Capital – Consultant, Member of the scientific advisory board. Eli Lilly and Company – Consultant. Equillium – Consultant. Ermium – Consultant. Everest Clinical Research Corp. – Consultant. Ferring – Consultant. First Wave – Consultant. Galapagos – Consultant. Galen Atlantica – Consultant. Genentech/Roche – Consultant, Member of scientific advisory board. Gilead – Consultant. Glenmark – Consultant. Gossamer Pharma – Consultant, Stock Shareholder. GSK – Consultant, Member of the scientific advisory board. Hoffmann-LaRoche – Consultant. Hot Spot Therapeutics – Consultant. Imhotex – Consultant. ImmunExt – Consultant. Immunic Therapeutics – Consultant. Index Pharma – Consultant, Member of the scientific advisory board. Intact Therapeutics – Consultant. JAKAcademy – Consultant. Janssen – Consultant, Member of scientific advisory board, Speakers Bureau. Japan Tobacco Inc. – Consultant. Kaleido Biosciences – Consultant. L.E.K. Consulting – Consultant. Landos Biopharma – Consultant. Leadiant – Consultant. LifeSci Capital – Consultant. Lument AB – Consultant. Millennium – Consultant. MiroBio – Consultant. Morphic Therapeutics – Consultant, Member of the scientific advisory board. Mylan – Consultant. Novartis – Member of the scientific advisory board. OM Pharma – Consultant. Origo BioPharma – Consultant, Member of scientific advisory board. Orphagen – Consultant. Otsuka – Consultant. Pandion Therapeutics – Consultant. Pfizer – Consultant, Member of the scientific advisory board. Play to Know AG – Consultant. Progenity – Consultant, Member of the scientific advisory board. Prometheus – Member of scientific advisory board. Prometheus Therapeutics and Diagnostics – Consultant. Protagonist – Consultant. PTM Therapeutics – Consultant. Q32 Bio – Consultant. Rebiotix – Consultant. RedHill – Consultant. REDX – Consultant. Roche – Consultant. Sandoz – Consultant. Sanofi – Consultant. Seres Therapeutics – Consultant. Silverback Therapeutics – Consultant. Surrozen Inc. – Consultant. Takeda – Consultant, Member of the scientific advisory board, Speakers Bureau. Teva – Consultant, Member of the scientific advisory board. Thelium – Consultant. Theravance – Consultant. Tigenix – Consultant. Tillotts Pharma – Consultant, Member of the scientific advisory board. UCB Pharma – Consultant. VHsquared Ltd. – Consultant. Viatris – Consultant. Western University – Employee. Ysios – Consultant. Ysopia – Consultant. Zealand Pharma – Consultant.

Julian Panés: Abbott – payment for the development of educational presentations, Speakers Bureau. AbbVie – Consultant, Grant/Research Support, support for travel to meetings, during the conduct of the study; payment for development of educational presentations. Arena – Consultant. Athos – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Ferring – Consultant. Galapagos – Consultant. Genentech-Roche – Consultant. GSK – Consultant. Janssen – Consultant, Payment for development of educational presentations, Speakers Bureau. Mirum – Consultant. Morphic – Consultant. MSD – Consultant. Nestlé – Consultant. Origo – Consultant. Pandion – Consultant. Pfizer – Consultant, Grant/Research Support, Payment for development of educational presentations, Speakers Bureau. Progenity – Consultant. Protagonist – Consultant. Revolo – Consultant. Robarts – Consultant. Roche – Payment for development of educational presentations. Takeda – Consultant, Support for travel to meetings during the conduct of the study, Speakers Bureau. Theravance – Consultant, Speakers Bureau. Wassermann – Consultant.

Walter Reinisch: 4SC – Advisory Committee/Board Member, Consultant. Abbott Laboratories – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Aesca – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Algernon – Consultant. AM Pharma – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. AMT – Consultant. AOP Orphan – Consultant. Aptalis – Speakers Bureau. Arena Pharmaceuticals – Consultant. Astellas – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Advisory Committee/Board Member, Consultant. Avaxia – Advisory Committee/Board Member, Consultant. Bioclinica – Consultant. Biogen IDEC – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celgene – Advisory Committee/Board Member, Consultant. Cellerix – Advisory Committee/Board Member, Consultant. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Centocor – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. ChemoCentryx – Advisory Committee/Board Member, Consultant. Covance – Consultant. Danone Austria – Advisory Committee/Board Member, Consultant, Speakers Bureau. DSM – Advisory Committee/Board Member, Consultant. Elan – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Consultant. Ernest & Young – Consultant. Falk Pharma GmbH – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant. Gatehouse Bio – Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Consultant. Grünenthal – Advisory Committee/Board Member, Consultant. ICON – Consultant. Immundiagnostik – Grant/Research Support, Speaker. Index Pharma – Consultant. Inova – Advisory Committee/Board Member, Consultant. Intrinsic Imaging – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support. Johnson & Johnson – Advisory Committee/Board Member, Consultant. Kyowa Hakko Kirin Pharma – Advisory Committee/Board Member, Consultant. Lipid Therapeutics – Advisory Committee/Board Member, Consultant. LivaNova – Consultant. Mallinckrodt – Consultant. Medahead – Consultant. MedImmune – Advisory Committee/Board Member, Consultant. Millenium – Advisory Committee/Board Member, Consultant. Mitsubishi Tanabe Pharma Corporation – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Nash Pharmaceuticals – Consultant. Nestle – Advisory Committee/Board Member, Consultant. Nippon Kayaku – Consultant. Novartis – Advisory Committee/Board Member, Consultant. Ocera – Advisory Committee/Board Member, Consultant. OMass – Consultant. Otsuka – Advisory Committee/Board Member, Consultant, Speakers Bureau. Parexel – Consultant. PDL – Advisory Committee/Board Member, Consultant, Speakers Bureau. Periconsulting – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Philip Morris Institute – Consultant. PLS Education – Speakers Bureau. Procter & Gamble – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. Provention – Consultant. Quell Therapeutics – Consultant. Robarts Clinical Trial – Consultant. Roland Berger GmbH – Consultant. Sandoz – Advisory Committee/Board Member, Consultant, Grant/Research Support. Schering-Plough – Advisory Committee/Board Member, Consultant, Speakers Bureau. Second Genome – Advisory Committee/Board Member, Consultant. Seres Therapeutics – Consultant. Setpoint Medical – Advisory Committee/Board Member, Consultant. Shire – Speakers Bureau. Sigmoid – Consultant. Sublimity – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Therakos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Consultant. TiGenix – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant. Vifor – Consultant, Speakers Bureau. Yakult – Speakers Bureau. Zealand – Advisory Committee/Board Member, Consultant. Zyngenia – Advisory Committee/Board Member, Consultant.

William Sandborn: AbbVie – Consultant, Grant/Research Support. Abivax – Consultant. Admirx – Consultant. Alfa sigma – Consultant. Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust) – Consultant. Alivio Therapeutics – Consultant. Allakos – Consultant, Stock Options. Allergan – Consultant. Amgen – Consultant. Applied Molecular Transport – Consultant. Arena Pharmaceuticals – Consultant, Grant/Research Support. Avexegen Therapeutics – Consultant. Aviva – Grant/Research Support. Bausch Health (Salix) – Consultant. BeiGene – Consultant, Stock Options. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, Grant/Research Support. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant, Grant/Research Support. Celltrion – Consultant. Cellularity – Consultant. Conatus – Consultant. Cosmo Pharmaceuticals – Consultant. Equillium – Consultant. Escalier Biosciences – Consultant. Ferring – Consultant. Forbion – Consultant. Genentech – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, Grant/Research Support. Glenmark Pharmaceuticals – Consultant. Gossamer Bio – Consultant, Stock Options. GSK – Grant/Research Support. Immunic (Vital Therapies) – Consultant. Incyte – Consultant. Index Pharmaceuticals – Consultant. Intact Therapeutics – Consultant. Janssen – Consultant, Grant/Research Support. Kyowa Kirin Pharmaceutical Research – Consultant. Kyverna Therapeutics – Consultant. Landos Biopharma – Consultant. Lilly – Consultant, Grant/Research Support. Miraca Life Sciences – Consultant. Nivalis Therapeutics – Consultant. Novartis – Consultant. Nutrition Science Partners – Consultant. Oppilan Pharma (acquired by Ventyx Biosciences) – Consultant, Stock Options. Otsuka – Consultant. Pandion Therapeutics – Consultant. Paul Hastings – Consultant. Pfizer – Consultant, Grant/Research Support. Progenity – Consultant, Stock Options. Prometheus Biosciences – Consultant, Grant/Research Support, Stock Options. Prometheus Laboratories – Consultant, Stock Options. Protagonist Therapeutics – Consultant. Provention Bio – Consultant. Reistone Biopharma – Consultant. Ritter Pharmaceuticals – Consultant. Seres Therapeutics – Consultant, Grant/Research Support. Shanghai Pharma Biotherapeutics – Consultant. Shire – Consultant, Grant/Research Support. Shoreline Biosciences – Consultant, Employee, Stock Options. Sienna Biopharmaceuticals – Consultant. Sigmoid Biotechnologies – Consultant. Sterna Biologicals – Consultant. Sublimity Therapeutics – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support. TheraVance Biopharma – Consultant, Grant/Research Support. Thetis Pharmaceuticals – Consultant. Tigenix – Consultant. Tillotts Pharma – Consultant. UCB Pharma – Consultant. Vendata Biosciences – Consultant. Ventyx Biosciences – Consultant, Stock Options. Vimalan Biosciences – Consultant, Stock Options. Vivelix Pharmaceuticals – Consultant. Vivreon Biosciences – Consultant, Stock Options. Zealand Pharma – Consultant.

Geert D’Haens: Abbvie – Advisor or Review Panel Member, Speaker fees. Ablynx – Advisor or Review Panel Member. AM Pharma – Advisor or Review Panel Member. Amakem – Advisor or Review Panel Member. Amgen – Advisor or Review Panel Member. Avaxia – Advisor or Review Panel Member. Biogen – Advisor or Review Panel Member, Speaker fees. Boehringer Ingelheim – Advisor or Review Panel Member. Bristol Myers Squibb – Advisor or Review Panel Member. Celgene/Receptos – Advisor or Review Panel Member. Celltrion – Advisor or Review Panel Member. Cosmo – Advisor or Review Panel Member. Covidien/Medtronics – Advisor or Review Panel Member. DrFALK Pharma – Advisor or Review Panel Member. Eli Lilly – Advisor or Review Panel Member. Engene – Advisor or Review Panel Member. Ferring – Advisor or Review Panel Member, Speaker fees. Galapagos – Advisor or Review Panel Member. Genentech/Roche – Advisor or Review Panel Member. Gilead – Advisor or Review Panel Member. GSK – Advisor or Review Panel Member. Hospira – Advisor or Review Panel Member. Immunic – Advisor or Review Panel Member. Johnson and Johnson – Advisor or Review Panel Member, Speaker fees. Lycera – Advisor or Review Panel Member. Medimetrics – Advisor or Review Panel Member. Merck Sharp Dome – Advisor or Review Panel Member, Speaker fees. Millenium/Takeda – Advisor or Review Panel Member, Speaker fees. Mitsubishi Pharma – Advisor or Review Panel Member. Mundipharma – Advisor or Review Panel Member, Speaker fees. Nextbiotics – Advisor or Review Panel Member. Norgine – Speaker fees. Novonordisk – Advisor or Review Panel Member. Otsuka – Advisor or Review Panel Member. Pfizer – Advisor or Review Panel Member, Speaker fees. Prometheus laboratories/Nestle – Advisor or Review Panel Member. Protagonist – Advisor or Review Panel Member. Robarts Clinical Trials – Advisor or Review Panel Member. Salix – Advisor or Review Panel Member. Samsung Bioepis – Advisor or Review Panel Member, Speaker fees. Sandoz – Advisor or Review Panel Member. Setpoint – Advisor or Review Panel Member. Shire – Advisor or Review Panel Member, Speaker fees. Teva – Advisor or Review Panel Member. Tigenix – Advisor or Review Panel Member. Tillotts – Advisor or Review Panel Member, Speaker fees. Topivert – Advisor or Review Panel Member. Versant – Advisor or Review Panel Member. Vifor – Advisor or Review Panel Member, Speaker fees.