P0674 - Efficacy and Safety of Guselkumab for Crohn’s Disease Through 3 Years: GALAXI-1 Long-term Extension

Sunday, October 22, 2023

3:30 PM - 7:00 PM PT

Location: Exhibit Hall

Presenting Author(s)

Anita Afzali, MD, MPH, FACG

Executive Vice Chair of Internal Medicine, Interim Division Director of Digestive Diseases, Associate Chief Medical Officer
University of Cincinnati College of Medicine
Cincinnati, OH

Anita Afzali, MD, MPH, FACG¹, Silvio Danese, MD, PhD², Remo Panaccione, MD³, Brian G. Feagan, MD⁴, David T. Rubin, MD⁵, Bruce E. Sands, MD, MS, FACG⁶, Walter Reinisch, MD⁷, Julian Panés, MD, PhD⁸, Aparna Sahoo, DO⁹, Natalie A. Terry, MD⁹, Leonardo Salese, MD⁹, Chris Corbett, MSc¹⁰, Tadakazu Hisamatsu, MD, PhD¹¹, Jane Andrews, MD¹², Geert D'Haens, MD, PhD¹³
¹University of Cincinnati College of Medicine, Cincinnati, OH; ²IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Lombardia, Italy; ³University of Calgary, Calgary, AB, Canada; ⁴Western University, London, ON, Canada; ⁵Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; ⁶Icahn School of Medicine at Mount Sinai, New York, NY; ⁷Medical University of Vienna, Vienna, Wien, Austria; ⁸Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; ⁹Janssen Research & Development, LLC, Spring House, PA; ¹⁰Janssen UK, High Wycombe, England, United Kingdom; ¹¹Kyorin University School of Medicine, Tokyo, Tokyo, Japan; ¹²Royal Adelaide Hospital & University of Adelaide, Adelaide, South Australia, Australia; ¹³Amsterdam University Medical Center, Amsterdam, Noord-Holland, Netherlands

Introduction: GALAXI-1 (NCT03466411) is a phase 2b study that evaluated guselkumab (GUS) in patients with moderate-to-severe Crohn’s disease (CD). We assessed clinical, endoscopic, and safety outcomes through 3 years in patients receiving GUS maintenance therapy in the GALAXI-1 long-term extension (LTE).

Methods: Upon completing the treat-through Week (Wk)-48 study, patients continued in the LTE receiving maintenance regimens that were assigned at randomization: GUS 100 mg subcutaneous (SC) every 8 wks (q8w), GUS 200 mg SC q4w, or ustekinumab (UST) 90 mg SC q8w. Key efficacy endpoints assessed at Wk 144 included CD Activity Index (CDAI) clinical remission, patient-reported outcome (PRO)-2 remission, and endoscopic response. Efficacy analysis sets are defined in Table 1. Safety analyses included all treated patients.

Results: Average duration of follow-up from baseline through Wk 152 was 100.9 wks in the combined GUS group (n=220) and 102.7 wks in the UST group (n=114); 151 patients randomized to GUS and 48 patients randomized to UST were treated in the LTE. Study drug discontinuations in the combined GUS group from Wks 48 to 152 were due to adverse events (AE, n[%]: 6[4.0]), lack of efficacy (2[1.3]), CD-related surgery (1[0.7]), lost to follow-up (4[2.6]), protocol deviation (1[0.7]), pregnancy (1[0.7]), refusal (1[0.7]), and patient withdrawal (9[6.0]). Among all randomized patients in the combined GUS group (including those who did not enter the LTE; primary efficacy analysis set), 54.1% were in CDAI clinical remission, 51.4% were in PRO-2 remission, and 34.7% were in endoscopic response at Wk 144 (Table 1). Outcomes among those who entered the LTE and among those with available data at each visit are summarized in Table 1. In the combined GUS group, serious AEs (SAEs, n[%]: 35[15.9]) and serious infections (12[5.5]) were infrequent. Most infections were not serious, mild to moderate in severity, and resolved without drug withdrawal. No cases of active tuberculosis, opportunistic infections, anaphylactic/serum sickness reactions, major adverse cardiovascular events, or deaths occurred during the LTE.

Discussion: Durable clinical and endoscopic efficacy were maintained over time through Wk 144 of the LTE. The safety profile of GUS was consistent with that of the approved indications. Most infections were not serious and did not result in discontinuation, while incidences of SAEs and serious infections were generally low.

Outcome	Analysis Population	Combined Guselkumab^a	Ustekinumab^b
Clinical remission (CDAI< 150), % (n/N)	Primary efficacy analysis set (NRI)^c	54.1 (100/185)	46.0 (29/63)
	LTE efficacy analysis set (NRI)^d	68.2 (103/151)	64.6 (31/48)
	Observed case analysis set^e	95.4 (103/108)	83.8 (31/37)
PRO-2 remission (AP mean daily score ≤1 and SF mean daily score ≤3, and no worsening of AP or SF from baseline), % (n/N)	Primary efficacy analysis set (NRI)^c	51.4 (95/185)	39.7 (25/63)
	LTE efficacy analysis set (NRI)^d	64.2 (97/151)	58.3 (28/48)
	Observed case analysis set^e	89.8 (97/108)	75.7 (28/37)
Endoscopic response (≥50% improvement from baseline in SES-CD or SES-CD ≤2), % (n/N)	Primary efficacy analysis set (NRI)^c	34.7 (61/176)	19.4 (12/62)
	LTE efficacy analysis set (NRI)^d	43.0 (61/142)	25.5 (12/47)
	Observed case analysis set^e	73.5 (61/83)	41.4 (12/29)
AP, abdominal pain; CDAI, Crohn's Disease Activity Index; LTE, long-term extension; NRI, nonresponder imputation; PRO-2, patient-reported outcome components of the CDAI [AP and SF]; SES-CD, Simple Endoscopic Score for Crohn’s Disease; SF, stool frequency ^a Includes patients randomized to the following guselkumab induction/maintenance regimens: 200 mg IV q4w→100 mg SC q8w; 600 mg IV q4w→200 mg SC q4w; 1200 mg IV q4w→200 mg SC q4w ^b Patients randomized to ustekinumab ^c Primary efficacy analysis set consists of randomized patients who received ≥1 dose of study medication, with NRI for patients with treatment failure or missing data, including those who did not enter the LTE ^d LTE efficacy analysis set consists of randomized patients who entered the LTE and received ≥1 dose of study medication in the LTE, with NRI for patients with treatment failure or missing data ^e Observed case analysis set consists of randomized patients who entered the LTE, received ≥1 dose of study medication in the LTE, and had available data at the outcome visit. Patients who received dose adjustment were excluded.

Table: Table 1. Clinical efficacy and endoscopic outcomes at Week 144.

Disclosures:

Anita Afzali: AbbVie – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Bristol Myers Squibb/Celgene – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. DiaSorin – Consultant. Eli Lilly – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Gilead – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. IBD Horizons – Owner/Ownership Interest. Janssen – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Takeda – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. TLL Pharmaceuticals – Consultant.

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.

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.

Brian Feagan: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau. AbolerIS – Consultant. AgomAB Therapeutics – Consultant. Allianthera – Consultant. Amgen – Advisory Committee/Board Member, Consultant. AnaptysBio – Consultant. Applied Molecular Transport Inc. – Consultant. Arena Pharma – Consultant. Avir – Consultant. Azora Therapeutics – Consultant. Baxter – Consultant. BioJamp – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Boston Pharma – Consultant. Bristol Myers Squibb – Consultant. Celgene/BMS – Advisory Committee/Board Member, Consultant. Connect BioPharma – Consultant. Cytoki – Consultant. Disc Medicine – Consultant. Duality – Consultant. EcoR1 – Advisory Committee/Board Member, Consultant. Eli Lilly – Consultant. Equillium – Consultant. Ermium – Consultant. Everest Clinical Research Corp. – Consultant. Ferring Pharmaceuticals – Consultant. First Wave – Consultant. Galapagos – Consultant. Galen Atlantica – Consultant. Genentech/Roche – Advisory Committee/Board Member, Consultant. Gilead – Consultant. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Glenmark – Consultant. Gossamer Pharma – Consultant, stock shareholder. Hoffmann-LaRoche – Consultant. Hot Spot Therapeutics – Consultant. Imhotex – Consultant. ImmunExt – Consultant. Immunic Therapeutics – Consultant. Index Pharma – Advisory Committee/Board Member, Consultant. Intact Therapeutics – Consultant. JAKAcademy – Consultant. Janssen – Advisory Committee/Board Member, Consultant, 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 – Advisory Committee/Board Member, Consultant. Mylan – Consultant. Novartis – Advisory Committee/Board Member. OM Pharma – Consultant. Origo BioPharma – Advisory Committee/Board Member, Consultant. Orphagen – Consultant. Otsuka – Consultant. Pandion Therapeutics – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Play to Know AG – Consultant. Progenity – Advisory Committee/Board Member, Consultant. Prometheus Therapeutics and Diagnostics – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. PTM Therapeutics – Consultant. Q32 Bio – Consultant. Rebiotix – Consultant. RedHill Biopharma – Consultant. Redx – Consultant. Roche – Consultant. Sandoz – Consultant. Sanofi – Consultant. Seres Therapeutics – Consultant. Silverback Therapeutics – Consultant. Surrozen Inc. – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Teva – Advisory Committee/Board Member, Consultant. Thelium – Consultant. Theravance – Consultant. Tigenix – Consultant. Tillotts Pharma – Advisory Committee/Board Member, Consultant. UCB Pharma – Consultant. VHSquared Ltd. – Consultant. Viatris – Consultant. Western University, Alimentiv Inc – Employee. Ysios – Consultant. Ysopia – Consultant. Zealand Pharma – Consultant.

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.

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.

Walter Reinisch: 4SC – Advisory Committee/Board Member, Speakers Bureau. 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 – 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. Calyx – 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. Ernst & Young – Consultant. Falk Pharma GmbH – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Fresenius – Consultant. 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, Speakers Bureau. 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. Landos – Consultant. Lipid Therapeutics – Advisory Committee/Board Member, Consultant. LivaNova – Consultant. Mallinckrodt – Consultant. Medahead – Consultant. Medice – Speakers Bureau. MedImmune – Advisory Committee/Board Member, Consultant. Millenium – Advisory Committee/Board Member, Consultant. Mitsubishi Tanabe Pharma – 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. Peri Consulting – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Philip Morris Institute – Consultant. PLS Education – Speakers Bureau. Procter and 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 – 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. Teva – Consultant. 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. Zygenia – Advisory Committee/Board Member, Consultant.

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.

Aparna Sahoo: Janssen – Employee.

Natalie Terry: Janssen – Employee.

Leonardo Salese: Janssen – Employee.

Chris Corbett: Janssen – Employee.

Tadakazu Hisamatsu: AbbVie GK – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Alfresa Pharma Corporation and EA Pharma Co., Ltd – Grant/Research Support. Daiichi-Sankyo – Grant/Research Support. EA Pharma Co, Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Eli Lilly – Consultant. Gilead Sciences – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Janssen Pharmaceutical K.K. – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. JIMRO Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. KISSEI PHARMACEUTICAL CO., LTD – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Kyorin Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mitsubishi Tanabe Pharma Corporation – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mochida Pharmacuetical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nichi-Iko Pharmaceutical Co., Ltd – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nippon Kayaku Co., Ltd – Grant/Research Support. Pfizer Japan Inc. – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Takeda Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Zeria Pharmaceutical Co., Ltd – Grant/Research Support.

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

Geert D'Haens: AbbVie – Consultant, Speakers Bureau. Alimentiv – Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant, Speakers Bureau. Cellitrion – Consultant, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant, Speakers Bureau. GlaxoSmithKline – Consultant, Speakers Bureau. Gossamerbio – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. Lilly – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Progenity – Consultant, Speakers Bureau. Prometheus Biosciences – Consultant, Speakers Bureau. Prometheus Laboratories – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau. Tillotts – Consultant, Speakers Bureau.