D0381 - Etrasimod 2mg Once Daily as Treatment for Patients With Moderately to Severely Active Ulcerative Colitis: Topline and Subgroup Analysis From ELEVATE UC 52 and ELEVATE UC 12

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Brian G. Feagan, MD

Alimentiv, Inc.; Western University
London, ON, Canada

Brian G. Feagan, MD¹, Laurent Peyrin-Biroulet, MD, PhD², William J. Sandborn, MD³, Geert D’Haens, MD, PhD⁴, Julian Panés, MD, PhD⁵, Andres Yarur, MD⁶, Douglas C. Wolf, MD⁷, Timothy E. Ritter, MD⁸, Stefan Schreiber, MD⁹, Sheldon Sloan, MD¹⁰, Fabio Cataldi, MD¹⁰, Kevin Shan, PhD¹⁰, Christopher J. Rabbat, PhD¹⁰, Michael Chiorean, MD¹¹, Filip Baert, MD, PhD¹², Bruce E. Sands, MD, MS, FACG¹³, Marla C. Dubinsky, MD¹⁴, Séverine Vermeire, MD, PhD¹⁵, Martina Goetsch, MD¹⁶, Silvio Danese, MD, PhD¹⁷
¹Alimentiv, Inc.; Western University, London, ON, Canada; ²University of Lorraine, Nancy, Lorraine, France; ³University of California San Diego, La Jolla, CA; ⁴Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands; ⁵Formerly, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; ⁶Cedars-Sinai Medical Center, Los Angeles, CA; ⁷Atlanta Gastroenterology Associates, Atlanta, GA; ⁸GI Alliance, Southlake, TX; ⁹University Hospital Schleswig-Holstein, Kiel University, Kiel, Schleswig-Holstein, Germany; ¹⁰Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc., San Diego, CA; ¹¹Swedish Medical Center, Seattle, WA; ¹²AZ Delta, Roeselare, West-Vlaanderen, Belgium; ¹³Icahn School of Medicine at Mount Sinai, New York, NY; ¹⁴Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY; ¹⁵University Hospitals Leuven, Leuven, Brussels Hoofdstedelijk Gewest, Belgium; ¹⁶Arena Pharmaceuticals Development GmbH, a wholly-owned subsidiary of Pfizer Inc., Zug, Zug, Switzerland; ¹⁷IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Molise, Italy

Introduction: Etrasimod (ETR), is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). We report a subgroup analysis according to prior exposure to advanced (biologic/Janus kinase inhibitor [JAKi]) therapy from the phase 3 trials ELEVATE UC 52 and ELEVATE UC 12 that evaluated efficacy and safety of ETR vs placebo (PBO) in adults with UC.

Methods: In ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369), adults (16-80 years) with moderately to severely active UC (based on modified Mayo Score of 4-9 with endoscopic subscore ≥2 and rectal bleeding subscore ≥1) and history of inadequate response, loss of response, or intolerance to ≥1 UC treatment were randomized 2:1 to once-daily ETR 2mg or PBO. ELEVATE UC 52 utilized a treat-through design comprising a 12-week induction period followed by a 40-week maintenance period. ELEVATE UC 12 comprised a 12-week induction period. Patients (pts) were stratified by prior exposure to biologic/JAKi therapy, baseline corticosteroid use, and baseline disease activity. Subgroup analyses were performed on primary and key secondary endpoints at Wk 12 and Wk 52 in ELEVATE UC 52, and Wk 12 in ELEVATE UC 12 in pts naïve to, or with prior exposure to, 1 or >1 biologic/JAKi.

Results: In ELEVATE UC 52, ETR-treated pts achieved statistically significant improvements vs PBO in the co-primary and all key secondary efficacy endpoints at Wks 12 and 52. Significant improvements vs PBO in all endpoints were observed in the biologic/JAKi-naïve and 1 prior biologic/JAKi subgroups (Table). In pts with >1 prior biologic/JAKi, efficacy was demonstrated across all endpoints, generally with lower rates vs PBO. In ELEVATE UC 12, ETR-treated pts achieved statistically significant improvements vs PBO in the co-primary and all key secondary efficacy endpoints at Wk 12. Significant improvements vs PBO in all endpoints were observed in biologic/JAKi-naïve subgroup, and in clinical remission in 1 prior biologic/JAKi subgroup. Efficacy was less evident in the >1 biologic/JAKi experienced subgroup.

Discussion: In ELEVATE UC 52 and ELEVATE UC 12, ETR was shown to be efficacious vs PBO in moderate to severe UC. While limited by small sample sizes, these subgroup analyses demonstrate consistent benefit of ETR vs PBO in biologic/JAKi-naïve and 1 prior biologic/JAKi subgroups with less evident benefit in the >1 biologic/JAKi subgroup.

Table. Subgroup Analysis of the Proportion of Patients Achieving the Primary and Key Secondary Efficacy Endpoints in the ELEVATE UC 52 and ELEVATE UC 12 Trials in the Overall Population and Stratified by Prior Biologic/JAKi Exposure^a
	ELEVATE UC 52 (treat-through) Week 12			ELEVATE UC 52 (treat-through) Week 52			ELEVATE UC 12 (induction only) Week 12
Endpoint, n (%) by no. of prior bio/ JAKis	PBO (n=144)	ETR 2mg (n=289)	% diff. from PBO (95% CI) [P value]	PBO (n=144)	ETR 2mg (n=289)	% diff. from PBO (95% CI) [P value]	PBO (n=116)	ETR 2mg (n=238)	% diff. from PBO (95% CI) [P value]
Clinical remission^b
Overall	10/135 (7.4)	74/274 (27.0)	19.8 (12.9 - 26.6) [< .001]	9/135 (6.7)	88/274 (25.4)	25.4 (18.4 - 32.4) [< .001]	17/112 (15.2)	55/222 (24.8)	9.7 (1.1 - 18.2) [.026]
Naïve	9/99 (9.1)	66/205 (32.2)	23.3 (14.7 - 31.8) [< .001]	8/99 (8.1)	75/205 (36.6)	29.0 (20.5 - 37.5) [< .001]	12/77 (15.6)	46/159 (28.9)	13.8 (3.3 - 24.4) [.010]
1 bio/JAKi	1/25 (4.0)	8/44 (18.2)	15.9 (1.6 - 30.2) [.029]	2/25 (8.0)	13/44 (29.5)	19.7 (3.2 - 36.2) [.020]	2/20 (10.0)	12/36 (33.3)	21.9 (2.4 - 41.3) [.028]
>1 bio/JAKi	2/20 (10.0)	7/40 (17.5)	4.4 (−12.7 - 21.5) [.613]	1/20 (5.0)	6/40 (15.0)	9.8 (−6.0 - 25.6) [.224]	3/19 (15.8)	4/43 (9.3)	−7.5 (−26.2 - 11.2) [.433]
Endoscopic improvement^c
Overall	19/135 (14.1)	96/274 (35.0)	21.1 (13.0 - 29.3) [< .001]	14/135 (10.4)	102/274 (37.2)	26.7 (19.0 - 34.4) [< .001]	21/112 (18.8)	68/222 (30.6)	12.1 (3.0 - 21.2) [.009]
Naïve	20/99 (20.2)	86/205 (42.0)	22.1 (12.1 - 32.2) [< .001]	16/99 (16.2)	86/205 (42.0)	26.8 (17.3 - 36.4) [< .001]	14/77 (18.2)	58/159 (36.5)	18.9 (7.9 - 29.8) [.001]
1 bio/JAKi	1/25 (4.0)	12/44 (27.3)	24.2 (9.3 - 39.0) [.001]	2/25 (8.0)	15/44 (34.1)	24.8 (7.9 - 41.8) [.004]	4/20 (20.0)	13/36 (36.1)	13.3 (−10.2 - 36.8) [.267]
>1 bio/JAKi	3/20 (15.0)	10/40 (25.0)	7.7 (−12.6 - 28.0) [.456]	1/20 (5.0)	12/40 (30.0)	24.0 (5.7 - 42.3) [.010]	4/19 (21.1)	7/43 (16.3)	−4.1 (−25.6 - 17.3) [.706]
Mucosal healing^d
Overall	6/135 (4.4)	58/274 (21.2)	16.9 (10.8 - 23.0) [< .001]	11/135 (8.1)	73/274 (26.6)	18.4 (11.4 - 25.4) [< .001]	10/112 (8.9)	36/222 (16.2)	7.4 (0.5 - 14.4) [.036]
Naïve	9/99 (9.1)	54/205 (26.3)	17.0 (8.6 - 25.5) [< .001]	13/99 (13.1)	60/205 (29.3)	16.9 (8.0 - 25.8) [< .001]	8/77 (10.4)	31/159 (19.5)	9.5 (0.5 - 18.5) [.039]
1 bio/JAKi	0/25 (0.0)	6/44 (13.6)	13.8 (3.1 - 24.5) [.012]	2/25 (8.0)	11/44 (25.0)	16.1 (0.1 - 32.0) [.048]	1/20 (5.0)	6/36 (16.7)	10.8 (−5.3 - 26.8) [.189]
>1 bio/JAKi	0/20 (0.0)	6/40 (15.0)	14.2 (3.0 - 25.5) [.013]	0/20 (0.0)	8/40 (20.0)	21.5 (8.4 - 34.6) [.001]	1/19 (5.3)	4/43 (9.3)	5.1 (−8.3 - 18.5) [.458]
bio, biologic; CI, confidence interval; ES, endoscopic subscore; ETR, etrasimod; JAKi, Janus kinase inhibitor; MMS, modified Mayo score; PBO, placebo; RB, rectal bleeding; SF, stool frequency. ^a Data based on Cochran–Mantel–Haenszel analysis of Full Analysis Set (all randomized patients who received ≥1 dose of study drug) and non-responder imputation method with baseline MMS 5-9 as the primary analysis and baseline MMS 4-9 as supplemental analysis. P values are 2-sided. ^b SF subscore = 0 (or = 1 with ≥1-point decrease from baseline), RB subscore = 0, and ES ≤1. ^c ES ≤1. ^d ES ≤1 with histologic remission measured by Geboes index score < 2.0.

Table: Table. Subgroup Analysis of the Proportion of Patients Achieving the Primary and Key Secondary Efficacy Endpoints in the ELEVATE UC 52 and ELEVATE UC 12 Trials in the Overall Population and Stratified by Prior Biologic/JAKi Exposure

Disclosures:

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.

Laurent Peyrin-Biroulet: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau. Amgen – Advisory Committee/Board Member, Consultant, Speakers Bureau. 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. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Forward Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Genentech – Advisory Committee/Board Member, Consultant, Speakers Bureau. H.A.C. Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. 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. Norgine – Advisory Committee/Board Member, Consultant, Speakers Bureau. Samsung Bioepis – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant, Speakers Bureau. Tillotts – Advisory Committee/Board Member, Consultant, Speakers Bureau. Vifor – Advisory Committee/Board Member, Consultant, Speakers Bureau.

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.

Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Personal fees. Athos – Personal fees. Boehringer Ingelheim – Personal fees. Celgene – Personal fees. Celltrion – Personal fees. Ferring Pharmaceuticals – Personal fees. Galapagos – Personal fees. Genentech/Roche – Personal fees. GSK – Personal fees. Immunic – Personal fees. Janssen Pharmaceuticals – Personal fees. Mirum – Personal fees. Morphic – Personal fees. Nestlé – Personal fees. Origo – Personal fees. Pandion – Personal fees. Pfizer Inc – Grant/Research Support, Personal fees. Progenity – Personal fees. Takeda – Personal fees. Theravance Biopharma – Personal fees. Wassermann – Personal fees.

Andres Yarur: Arena Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant. Prometheus Laboratories – Consultant. Takeda – Advisory Committee/Board Member.

Douglas Wolf: AbbVie – Consultant, Speakers Bureau. Arena Pharmaceuticals – Consultant, Speakers Bureau. Bristol Myers Squibb – Consultant, Speakers Bureau. Eli Lilly – Consultant, Speakers Bureau. Janssen Pharmaceuticals – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau.

Timothy Ritter: AbbVie – Advisor or Review Panel Member. Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc – Advisor or Review Panel Member. Boehringer Ingelheim – Advisor or Review Panel Member. Bristol Myers Squibb – Advisor or Review Panel Member, Speakers Bureau. Eli Lilly – Advisor or Review Panel Member. Ferring Pharmaceuticals – Advisor or Review Panel Member. Genetech – Advisor or Review Panel Member. Gilead Sciences – Advisor or Review Panel Member. Gossamer Bio – Advisor or Review Panel Member. Intercept Pharmaceuticals – Advisor or Review Panel Member. Janssen Pharmaceuticals – Advisor or Review Panel Member, Speakers Bureau. Pfizer – Advisor or Review Panel Member, Speakers Bureau. Prometheus Biosciences – Advisor or Review Panel Member. Sanofi – Advisor or Review Panel Member. Takeda – Advisor or Review Panel Member, Speakers Bureau.

Stefan Schreiber: AbbVie – Consultant, Personal fees. Arena – Consultant, Personal fees. Biogen – Consultant, Personal fees. Bristol-Myers Squibb – Consultant, Personal fees. Celgene – Consultant, Personal fees. Celltrion – Consultant, Personal fees. Eli Lilly and Company – Consultant, Personal fees. Falk – Consultant, Personal fees. Ferring – Consultant, Personal fees. Fresenius – Consultant, Personal fees. Galapagos/Gilead Sciences – Consultant, Personal fees. IMAB – Consultant, Personal fees. Janssen – Consultant, Personal fees. MSD – Consultant, Personal fees. Mylan – Consultant, Personal fees. Pfizer Inc – Consultant, Personal fees. Protagonist – Consultant, Personal fees. Provention Bio – Consultant, Personal fees. Takeda – Consultant, Personal fees. Theravance – Consultant, Personal fees.

Sheldon Sloan: Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc – Employee.

Fabio Cataldi: Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc – Employee.

Kevin Shan: Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc – Employee.

Christopher Rabbat: Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc – Employee.

Michael Chiorean: AbbVie – Consultant, Speakers Bureau. Arena – Consultant. Bristol Myers_Squibb – Speakers Bureau. Eli Lilly – Consultant. Janssen – Consultant, Speakers Bureau. Medtroinc – Consultant, Speakers Bureau. Pfizer Inc – Consultant, Speakers Bureau. Prometheus – Consultant. Takeda – Consultant, Speakers Bureau.

Filip Baert: AbbVie – Grant/Research Support, Honoraria, Speakers Bureau. Amgen – Grant/Research Support, Honoraria. Arena Pharmaceuticals – Honoraria, Speakers Bureau. Celgene – Honoraria. Celltrion Healthcare – Honoraria. Ferring Pharmaceuticals – Honoraria, Speakers Bureau. Fresenius Kabi – Honoraria. Janssen Pharmaceuticals – Grant/Research Support, Honoraria, Speakers Bureau. MSD – Honoraria, Speakers Bureau. Pfizer – Honoraria, Speakers Bureau. Sandoz – Honoraria. Takeda – Grant/Research Support, Honoraria, Speakers Bureau.

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.

Marla Dubinsky: AbbVie – Consultant. Arena Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Galapagos – Consultant. Genetech – Consultant. Gilead Sciences – Consultant. Janssen Pharmaceuticals – Consultant. Pfizer Inc – Consultant. Prometheus Laboratories – Consultant. Takeda – Consultant. Trellus Health – Shareholder. UCB – Consultant.

Séverine Vermeire: AbbVie – Consultant, Grant/Research Support. Arena – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Ferring – Consultant. Galapagos – Consultant. Genentech/Roche – Consultant. Gilead – Consultant. Hospira – Consultant. Janssen – Consultant. Johnson & Johnson – Grant/Research Support. MSD – Consultant. Mundipharma – Consultant. Pfizer – Consultant, Grant/Research Support. Progenity – Consultant. Second Genome – Consultant. Shire – Consultant. Takeda – Consultant, Grant/Research Support.

Martina Goetsch: Arena Pharmaceuticals Development GmbH, a wholly-owned subsidiary of Pfizer Inc – Employee.

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.