E0344 - Efficacy Outcomes by Symptom-Based Response Status After Induction: Week-48 Results from the GALAXI 1 Trial of Guselkumab in Crohn’s Disease

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Anita Afzali, MD, MPH, FACG

The Ohio State University Wexner Medical Center
Columbus, Ohio

Anita Afzali, MD, MPH, FACG¹, Julian Panés, MD², David T. Rubin, MD, FACG³, Bruce E. Sands, MD, MS, FACG⁴, Walter Reinisch, MD, PhD⁵, Geert D’Haens, MD, PhD⁶, Aparna Sahoo, MD⁷, Mary Ellen Frustaci, MS⁷, Zijiang Yang, MS⁷, William J. Sandborn, MD⁸, Remo Panaccione, MD⁹, Tadakazu Hisamatsu, MD, PhD¹⁰, Silvio Danese, MD, PhD¹¹, Jane Andrews, MD¹², Brian G. Feagan, MD¹³, Mario Gomez, MD¹⁴, Natalie Terry, MD, PhD¹⁴
¹The Ohio State University Wexner Medical Center, Columbus, OH; ²Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; ³University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL; ⁴Icahn School of Medicine at Mount Sinai, New York, NY; ⁵Medical University of Vienna, Vienna, Wien, Austria; ⁶Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands; ⁷Janssen Research & Development, LLC, Spring House, PA; ⁸University of California San Diego, La Jolla, CA; ⁹University of Calgary, Calgary, AB, Canada; ¹⁰Kyorin University School of Medicine, Tokyo, Tokyo, Japan; ¹¹IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Molise, Italy; ¹²Royal Adelaide Hospital & University of Adelaide, Adelaide, South Australia, Australia; ¹³Alimentiv, Inc.; Western University, London, ON, Canada; ¹⁴Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA

Introduction: The GALAXI 1 study evaluated the efficacy and safety of guselkumab (GUS) in patients (pts) with moderate to severe Crohn’s disease (CD). The study employed a “treat-through" design in which all pts randomized to active treatment continued that treatment through week (Wk) 48, regardless of response to intravenous (IV) induction. Here, we report a post hoc analysis of clinical and endoscopic efficacy outcomes to GUS maintenance treatment in pts with symptom-based response to induction treatment.

Methods: Pts were randomized 1:1:1:1:1 to induction with GUS 200, 600, or 1200mg IV, ustekinumab (UST) ~6mg/kg IV, or PBO IV. At Wk12, pts transitioned to maintenance dosing as follows: GUS 200mg IVà100mg SC q8w, GUS 600mg IVà200mg SC q4w, GUS 1200mg IVà200mg SC q4w, UST ~6mg/kg IVà90mg SC q8w, PBO CDAI clinical non-respondersàUST ~6mg/kg IVà90mg SC q8w, and PBO CDAI clinical responders àPBO SC q4w. Response to induction was defined as ≥30% decrease from baseline to Wk12 in average daily stool frequency and/or abdominal pain score and both not worse than baseline. Analyses of Wk48 endpoints were prespecified but not controlled for multiplicity. The study was not powered to evaluate differences in efficacy among treatment groups at Wk48 and UST was used as a reference arm.

Results: Of pts in the primary efficacy analysis set, 43/61 (70%), 46/63 (73%), and 41/61 (67%) in the respective GUS 200, 600, and 1200mg groups, 45/63 (71%) in the UST group, and 23/61 (38%) in the PBO group exhibited response to induction. Percentages of pts in response after induction who achieved clinical remission at Wk48 ranged from 63% to 89% among GUS dose groups compared with 57% to 73% in the overall population (Table 1). Most pts in clinical remission at Wk48 were also in corticosteroid-free remission. PRO-2 remission rates at Wk48 among pts in response after induction ranged from 59% to 80%, and CDAI clinical response rates ranged from 73% to 96%. Endoscopic response rates ranged from 49% to 56%.

Discussion: This post hoc analysis of a study with a “treat-through” design showed that pts randomized to GUS who were in symptom-based response after induction were more likely to achieve clinical and endoscopic outcomes at Wk48 compared with the overall population, regardless of the induction dose received. The “treat-through” study design allows for the evaluation of outcomes during maintenance in all pts randomized to treatment, rather than only induction responders.

	Guselkumab						Ustekinumab ~6 mg/kg IV à90 mg SC q8w
	200 mg IV à100 mg SC		600 mg IV à 200 mg SC		1200 mg IV à200 mg SC		Ustekinumab ~6 mg/kg IV à90 mg SC q8w
	Overall^a	Resp^a	Overall^a	Resp^a	Overall^a	Resp^a	Overall^a	Resp^a
N	61	43	63	46	61	41	63	45
CDAI clinical remission (CDAI score < 150)^{b, c}	64%	72%	73%	89%	57%	63%	59%	69%
Corticosteroid-free CDAI clinical remission (CDAI score < 150 at Wk 48 and not receiving corticosteroids at Wk 48)^{b, c}	59%	67%	71%	87%	56%	61%	59%	69%
PRO-2 remission (unweighted CDAI component of daily average AP score ≤1 AND the unweighted CDAI component of daily average SF ≤3, and no worsening of AP or SF from baseline)^{b, c}	57%	63%	70%	80%	51%	59%	46%	51%
CDAI clinical response (≥100-point reduction from baseline in CDAI score or CDAI score < 150)^{b, c}	74%	81%	84%	96%	67%	73%	68%	78%
Endoscopic response (≥50% improvement from baseline in SES-CD or SES-CD ≤2)^{b, c}	44%	49%	46%	54%	44%	56%	30%	31%
AP=Abdominal pain; CDAI=Crohn’s disease activity index; IV=Intravenous; PRO-2=Patient-reported CDAI components of abdominal pain and stool frequency; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease; Wk=week ^a “Overall” defined as all randomized patients who were in the primary efficacy analysis set of the treat-through study; “Resp” defined as ≥30% decrease from baseline at Wk12 in average daily SF and/or AP score and both not worse than baseline ^b Patients who had a prohibited change in concomitant CD medication, a CD-related surgery, or discontinued study agent due to lack of efficacy, or an adverse event of worsening CD prior to the designated analysis timepoint, were considered not to have achieved the endpoint. ^cPatients who had insufficient data to calculate the outcome measure at the designated analysis timepoint were considered not to have achieved the endpoint.

Table: Table 1. Efficacy Outcomes at Week 48 Overall and in Patients with Symptom-based Response to Induction Treatment

Disclosures:

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.

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.

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.

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.

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.

Aparna Sahoo: 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).

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.

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.

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.

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.

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

Mario Gomez: Janssen Research & Development, LLC – Employee, Stock-publicly held company(excluding mutual/index funds).

Natalie Terry: Janssen Research & Development, LLC – Employee, Stock-publicly held company(excluding mutual/index funds).