Introduction

Electrical stimulation of the cervical vagus nerve (VNS) activates the inflammatory reflex to reduce inflammation and ameliorate disease in subjects with therapy-refractoryCrohn’s disease (CD) (D’Haens et.al., under review). Considering the surgical implantation of a neurostimulator, we hypothesized that using a transcutaneous device to stimulate the auricular cutaneous branch of the vagus nerve (taVNS), could be used as a preoperative screening test. Should taVNS activate the inflammatory reflex, the blood cytokine response to an ex vivo endotoxin challenge would decrease (Koopman et.al., PNAS 2016; 113(29): 8284). The objective was to explore whether a noninvasive taVNS procedure could be used preoperatively to identify which patients would ultimately respond clinically to VNS administered via an implanted device.

Aims & Methods

This describes an exploratory substudy within an open label study of patients with moderately to highly active CD. The patients (17 enrolled, 13 male, 35 years [range 21-62], CDAI±SEM= 306±15) previously failed biological treatment (i.e TNF antagonists, vedolizumab). At screening, a baseline blood sample was drawn and incubated (37 °C, 24 hours) in a standardized and validated culture system containing endotoxin (TruCulture, RBM). A taVNS device (Cerbomed), approved for the treatment of epilepsy, depression, and pain, was fitted to the left ear and stimulated for 5 minutes at an intensity that provided sensation that was “noticeable but not painful.” Additional blood samples were drawn at 1 and 4 hours post-stimulation and incubated, as described above. Plasma cytokine levels (TNF, IL-1b, IL-6) were quantitated (MSD). Following successful screening, implantation of a VNS device (Cyberonics) was performed. Daily VNS treatment was initiated after 2-weeks postoperative recovery and continued to week 16. Change from baseline levels of bioassay cytokines was compared between those patients who achieved a CDAI-100 response (responders) and patients who did not achieve a CDAI-100 response at week 16 (non-responders). Differences between groups were assessed by t-test.

Results

13 patients consented and took part in the exploratory sub-study. Of these, 8 patients were responders to VNS therapy at week 16 and 5 were non-responders. Of the responders, approximately half had decreased or no change in bioassay cytokine levels at both 1 and 4 hours and approximately half had increased or minimal change in cytokine levels. Similarly, of the non-responders, approximately half had decreased or no change in bioassay cytokine levels at both 1 and 4 hours and approximately half had increased or minimal change in cytokine levels. There was no significant difference at 1 or 4 hours between the change from baseline bioassay levels of TNF, IL-1b, or IL-6 in the responders compared to the non-responders (p>0.4).

Conclusion

No differences were observed in bioassay cytokines following taVNS that can be predictive of an individual patient’s clinical response to VNS at week 16. This may be due to the taVNS device not consistently activating the correct nerve fibers, a disconnect between the ability of taVNS and VNS to activate the inflammatory reflex and affect inflammation in CD patients, or the relatively high concentration of endotoxin used within the validated bioassay. Use of a noninvasive test to predict clinical response to an implanted vagus nerve stimulation device would be useful. However, data using taVNS have not yet validated the clinical utility of this screening approach.​

Disclosure

G.D’H: consulting and/or lecture fees from AbbVie, Alimentiv, Boehringer Ingelheim GmbH, BMS, Eli Lilly, Ferring, Galapagos, GlaxoSmithKline, Johnson and Johnson, Pfizer, Takeda, Tillotts Pharma, Versant; research grants from Pfizer, Takeda, Eli Lilly; and speaking honoraria from AbbVie, Tillotts, Pfizer and Johnson and Johnson. ME: Honoraria and consultancy fees from MSD, AbbVie, Takeda, Ferring, Tillotts, Orion Pharma, Otsuka, and ITH. ZC: nothing to report. SD: speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor. RvdB: nothing to report. ML: speaker and/or principal investigator for: Abbvie, Alimentiv, Bristol Myers Squibb, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Galapagos, Gilead, GlaxoSmithKline, Janssen-Cilag, Medtronic, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Takeda, Tillotts, Tramedico; research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Achmea healthcare, Galapagos and ZonMW. GF: Personal Fees: Takeda, Abbvie, Janssen, Pfizer, Celltrion, Sandoz, AlfaSigma, Samsung Bioepis, Amgen, Roche, Ferring, Mylan, Gilead, Galapagos. SH: consultant for AbbVie, Allergan, Amgen, Arena, Bristol-Myers Squibb, Celgene, Celltrion, Genentech, Gilead, GSK, Janssen, Lilly, Merck, Nestle, Novartis, Pfizer, Progenity, Prometheus, Receptos, Salix, Samsung Bioepis, Seres Therapeutics, Takeda, TiGenix, UCB Pharma, and Vhsquared; speaker for AbbVie, Janssen, and Takeda. RZ: shareholder of SetPoint Medical. DC: shareholder of SetPoint Medical. YAL: shareholder of SetPoint Medical.

Introduction

Guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, is highly efficacious in participants (pts) with Crohn’s disease (CD) after intravenous (IV) or subcutaneous (SC) induction followed by SC maintenance. This analysis characterized pharmacokinetics (PK) and exposure-response (E-R) for efficacy and safety of both administration routes and confirmed assumptions for the development of IV and SC induction formulations.

Aims & Methods

GUS efficacy and safety in pts with moderate to severely active CD were evaluated in the phase 2 GALAXI 1 (200, 600, or 1200 mg IV at week [W]0, W4, and W8),¹ phase 3 GALAXI 2 and 3 (200 mg IV at W0, W4, and W8),² and phase 3 GRAVITI studies (400 mg SC at W0, W4, and W8).³ All studies used treat-through designs and the same SC maintenance dose regimens (100 mg q8w or 200 mg q4w). With an estimated ~50% bioavailability of SC GUS, the 2-fold higher SC induction dose was predicted to provide similar overall exposure and noninferior trough concentrations compared with the IV dose.
To characterize GUS PK, a population PK model was used to simulate exposure metrics for IV and SC induction using individual post-hoc PK parameters and actual pt dosages. Relationships between GUS exposure and select efficacy endpoints (clinical response, clinical remission, and endoscopic response) at week 12 were assessed.

Results

SC induction resulted in higher trough serum concentrations (at W12), lower peak serum concentrations, similar average concentrations (W0–W12), and similar area under the concentration-time curves (W0–W12) vs IV induction (Table). Regardless of induction route (IV or SC) or maintenance regimen, GUS serum concentrations reached steady state by W24.
W12 efficacy outcomes were comparable within GUS concentration quartiles after SC vs IV induction. Although pts with higher serum GUS concentrations tended to achieve greater W12 efficacy outcomes, this trend was no longer evident after accounting for a pt’s drug clearance or the half-life of the drug. W48 outcomes were similar in pts who received the same maintenance regimen, regardless of induction dose route. No positive E-R trends were seen between peak concentration and W12 efficacy endpoints; thus, the higher peak concentration observed with IV induction did not seem to improve efficacy. Across concentration quartiles, the incidence of safety events was comparable between pts who received GUS IV or SC induction regimens. No positive associations between serum concentrations and adverse events (infections, serious infections, and serious adverse events) or abnormal liver function tests were observed.

Conclusion

Average serum GUS concentrations and E-R relationships were similar after IV vs SC induction and had no impact on safety, supporting the use of either administration route and induction dose regimen in CD patients.

References

1. Sandborn WJ, et al. Guselkumab for the treatment of Crohn's disease: induction results from the phase 2 GALAXI-1 study. Gastroenterology. 2022; 162(6):1650-1664.e8.
2. Panaccione R, et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. Gastroenterology. 2024; 166 (5 Supplement):1057b.
3. Hart A, et al. Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active Crohn's disease: results from the phase 3 GRAVITI study. Gastroenterology. 2025; S0016-5085(25)00522-0.

Disclosure

Geert D’Haens has served as advisor and/or speaker for Abbvie, Abivax, Agomab, Alimentiv, Anaptys Bio, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Glaxo Smith Kline, Index Pharmaceuticals, Johnson and Johnson, Merck, Polpharm, Prometheus biosciences, Sanofi, Takeda, Tillotts.
Omoniyi J. Adedokun, Tae Eun Yang, Nat A. Terry, Mobolaji Olurinde, Rian Van Rampelbergh, and Marion L. Vetter are employees of Janssen Research & Development (a Johnson & Johnson Company) and may own company stock/stock options.
Bruce E. Sands reports potential conflicts of interest with AbbVie, Abivax, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Evommune, Ferring, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Janssen, Kaleido, Kallyope, Lilly, Merck, Microbiotica, Mobius Care, Morphic Therapeutics, MRM Health, Pfizer, Nexus Therapeutics, Nimbus Discovery, Odyssey, Therapeutics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biotherapeutics, Sun Pharma, Surrozen, Target RWE, Takeda, Teva, Theravance Biopharma, TLL Pharmaceutical, TR1X, Union Therapeutics and Ventyx Biosciences.
Silvio Danese reports potential conflicts of interest with AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity, Takeda, TiGenix, UCB, and Vifor.
Tadakazu Hisamatsu reports potential conflicts of interest with AbbVie, Bristol Myers Squibb, Daiichi-Sankyo, EA Pharma Co, Ltd., Eli Lilly, Gilead Sciences, Janssen Research & Development, LLC., JIMRO, Kissei Pharmaceutical Co, Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Inc., and Takeda Pharmaceutical Co., Ltd.
Remo Panaccione reports potential conflicts of interest with Abbivax, Abbott, AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Viatris, Ventyx, and UCB.

Introduction

Biologic treatment plays a crucial role in managing Crohn’s disease (CD) prior to considering surgical options. However, treatment failure and withdrawal are common and jeopardize the maintenance of remission in CD.

Aims & Methods

This study aims to analyse and compare drug survival – used as a surrogate marker for treatment efficacy – and reasons for withdrawal of the commonly used biologics in CD. This is a retrospective, monocentric study of CD patients treated at the University Hospital Heidelberg and registered in the IBD database from 2017 to April 2024. The primary endpoint was drug survival; the secondary endpoint was reason for treatment withdrawal. Drug survival was analysed using Kaplan-Meier estimators in SPSS. First-line treatments with Adalimumab (ADA) and Infliximab (IFX) were compared using log-rank tests following 1:2 Propensity Score Matching in R Studio.

Results

Of 1020 IBD patients, 396 CD patients were eligible. The included cohort had a median age of 48 years (IQR: 35-60) with 44.9 % male and a median disease duration of 9 years (IQR: 2-20) until therapy initiation. 25.5 % reported to have perianal disease. Among their 1035 immunosuppressive treatments, 771 involved the biologics ADA, IFX, Vedolizumab (VDZ) and Ustekinumab (UST). ADA showed the highest median drug survival (27 months; 95 % CI: 19.8-34.2) which was significantly longer than that of IFX (14 months; 95 % CI: 10.6-17.4). Median drug survival of UST was 22 months (95 % CI: 13.4-30.6) and 15 months for VDZ (95 % CI: 7.2-22.8).
The most common reason for withdrawal for ADA (41.3 %), VDZ (76.8 %) and UST (61.8 %) was insufficient response which included persistent clinical symptoms, elevated inflammatory markers, or endoscopic activity. For IFX side effects (24.4 %), insufficient response (21.1 %) and immunogenicity (20.3 %) were almost equally present.
In first-line treatments (47 IFX vs. 94 ADA-cases), the log-rank test showed significantly longer drug survival for ADA compared to IFX (49.7 vs. 33.6 months; p=0.034).

Conclusion

Adalimumab showed greater overall and first-line drug survival than infliximab, hinting at a preference of adalimumab in clinical practice. Most biologic treatments were withdrawn due to insufficient response. More prospective, multicentric studies are encouraged to confirm these findings and to support optimised treatment decisions.

Disclosure

Annika Gauss received lecture fees and consulting fees from AbbVie, Johnson & Johnson, Takeda, Tillotts Pharma, Hexal, Pfizer and Sanofi.

Introduction

Accurate and timely endoscopic evaluation is critical for the management of postoperative Crohn’s disease (CD). Although numerous established and novel indices exist, their relative operating properties and the optimal instrument for routine use in clinical and research settings are unknown.

Aims & Methods

We characterised the reliability and responsiveness of both historical and novel endoscopic indices using centrally assessed ileocolonoscopy videos from a randomised controlled trial comparing infliximab versus placebo for preventing postoperative CD (PREVENT; NCT01190839). Three blinded central readers independently assessed 70 videos from the PREVENT trial using the Rutgeerts and modified Rutgeerts scores, POCER index, REMIND score, Simple Endoscopic Score for CD (SES-CD), and the CD Endoscopic Index of Severity (CDEIS). Indices were scored separately for the neoterminal ileum, the anastomosis (including the blind loop of a side-to-side anastomosis), and the distal colonic segment. Intra- and inter-rater reliability was quantified using the intraclass correlation coefficient (ICC) and was interpreted using the Landis and Koch benchmarks.¹ Responsiveness was quantified using the win probability (WinP), defined as the probability of a patient receiving infliximab having a better endoscopic score than a patient receiving placebo, and interpreted using Cohen’s benchmarks.²

Results

Inter-rater reliability was substantial for the Rutgeerts (ICC 0.74 [95% CI: 0.62-0.83]) and modified Rutgeerts scores (0.79 [0.68-0.86]), ileal REMIND score (0.79 [0.67-0.87]), SES‑CD (0.79 [0.70-0.86]), and CDEIS (0.80 [0.72-0.86]). Inter-rater reliability was moderate for the POCER index (ICC 0.49 [0.26-0.64]) and fair for the anastomotic REMIND score (0.30 [0.14-0.47]). Intra-rater reliability was almost perfect for all indices (ICC≥0.81) (Table 1). The Rutgeerts (WinP 0.77 [95% CI: 0.65-0.86]) and modified Rutgeerts scores (WinP 0.81 [0.69-0.89]), ileal REMIND score (WinP 0.83 [0.72-0.91]), SES-CD (WinP 0.80 [0.66-0.89]), and CDEIS (WinP 0.75 [0.61-0.86]) demonstrated a large degree of responsiveness when treatment assignment was the criterion for change. The POCER index (WinP 0.54 [0.43-0.65]) and the anastomotic REMIND score (WinP 0.53 [0.42-0.64]) had a small degree of responsiveness. The reliability and responsiveness of all indices were consistently lower when assessed at the anastomosis or distal colon compared to the neoterminal ileum.

Table 1. Reliability and responsiveness of endoscopic scores

Conclusion

Existing endoscopic indices are reliable and responsive for assessing postoperative CD activity in the neoterminal ileum but are suboptimal for assessing the anastomosis or distal colon.

References

1. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33 (1):159-174.
2. Zou G, Zou L, Qiu SF. Parametric and nonparametric methods for confidence intervals and sample size planning for win probability in parallel-group randomized trials with Likert item and Likert scale data. Pharm Stat 2023; 22 (3):418-439.

Disclosure

JH reports consulting fees from Abbvie,Alimentiv Inc,Eli Lilly,Janssen,and Takeda.
SKV,GZ,LMS report consulting fees from Alimentiv Inc.
BB reports advisory/speaker fees from: Ferring,Janssen,Abbvie,Takeda,Pfizer,BMS,Merck,Sandoz,Organon,Lifelabs,Celltrion,Alimentiv,Gilead,Iterative Health,Celgene,Merck,Amgen,Pendopharm,Eli Lilly,Fresenius Kabi,Mylan,Viatris,Bausch Health,BioJamp Pharma,Eupraxia; research support: Janssen,Abbvie,GSK,BMS,Amgen,Genentech,Merck.
MAS reports advisory fees from: Janssen,Takeda,Sandoz,Samsung Bioepis,Galapagos,AbbVie,Bristol-Myers Squibb,Tillotts,Pfizer,STADA,Sanofi,MSD; and lecture fees from: Bristol-Myers Squibb,Janssen,Takeda,MSD,Falk,AbbVie,Galapagos,Lilly.
MH is a former employee of Alimentiv Inc.
JR is an employee of Alimentiv Inc.
PDC reports advisory/speaker/consulting fees from AbbVie,Baxter,Ferring,Janssen,Celltrion,Emerge Health,Shire,and Takeda. PDC is sup­ported by an NHMRC Emerging Leader 2 Fellowship and reports research support from AbbVie,Ferring,Shire,Janssen,Pfizer,and Takeda.
MR reports advisory/consulting fees from Abbvie,Janssen,UCB,Takeda,Pfizer,BMS,Organon,Amgen,Genentech,Gilead,Salix,Prometheus,Lilly,Celgene,Boehringer Ingelheim Pharmaceuticals Inc. (BIPI),Celltrion,Roche,Merck,Sanofi,Biocon,Abavax.
SS reports research grants from Pfizer
RWS reports advisory/consulting fees from AbbVie,Bristol Myers Squibb,CorEvitas,Eli Lilly,Exact Sciences,Gilead,Johnson and Johnson,Merck,Okura Theraeutics,Pfizer,and Takeda; received investigator initiated research funding from Abbvie,Bristol Myers Squibb,Johnson and Johnson,and Merck; holds intellectual property and equity on medical imaging and endoscopic analysis technologies licensed by the University of Michigan to PreNovo,LLC,AMI,LLC and PathwaysGI,Inc.
MD reports speaking fees from Bristol Meyers Squibb,Takeda,Galapagos,Janssen,Dr. Falk; advisory board fees from Abbvie,Bristol Meyers Squibb,Celltrion,Galapagos/Alfasigma,Janssen,Takeda; grant/research support: Pfizer,Bristol Meyers Squibb,Galapagos/Alfasigma,Janssen.
GDH reports advisory/speaker fees from Abbvie,Agomab Therapeutics,Alimentiv,AstraZeneca,Bristol Meiers Squibb,Cytoki,Celltrion,Eli Lilly,Exeliom Biosciences,Ferring,Galapagos,Glaxo Smith Kline,Pfizer,Polpharm,Immunic,Index Pharmacueticals,Johnson and Johnson,Merck,ProciseDx,Roivant,Seres Health,Takeda,Tillotts and Ventyx.
LPB reports consulting fees from Abbvie,Abivax,Adacyte,Alimentiv,Amgen,Applied Molecular Transport,Arena,Banook,Biogen,BMS,Celltrion,Connect Biopharm,Cytoki Pharma,Enthera,Ferring,Fresenius Kabi,Galapagos,Genentech,Gilead,Gossamer Bio,GSK,IAC Image Analysis,Index Pharmaceuticals,Inotrem,Janssen,Lilly,Medac,Mopac,Morphic,MSD,Nordic Pharma,Novartis,Oncodesign Precision Medicine,ONO Pharma,OSE Immunotherapeuthics,Pandion Therapeuthics,Par' Immune,Pfizer,Prometheus,Protagonist,Roche,Samsung,Sandoz,Sanofi,Satisfay,Takeda,Telavant,Theravance,Thermo Fischer,Tigenix,Tillots,Viatris,Vectivbio,Ventyx,Ysopia; grants support from Celltrion,Fresenius Kabi,Medac,MSD,Takeda; lecture fees from Abbvie,Alfasigma,Amgen,Arena,Biogen,Celltrion,Ferring,Galapagos,Genentech,Gilead,Janssen,Kern Pharma,Lilly,Medac,MSD,Nordic Pharma,Pfizer,Sandoz,Takeda,Tillots,Viatris; and support for travel from Abbvie,Alfasigma,Amgen,Celltrion,Connect Biopharm,Ferring,Galapagos,Genentech,Gilead,Gossamer Bio,Janssen,Lilly,Medac,Morphic,MSD,Pfizer,Sandoz,Takeda,Thermo Fischer,Tillots.
SD reports consulting fees from AbbVie,Alimentiv Inc,Allergan,Amgen,AstraZeneca,Athos Therapeutics,Biogen,Boehringer Ingelheim,Bristol Myers Squibb,Celgene,Celltrion,Dr Falk Pharma,Eli Lilly,Enthera,Ferring Pharmaceuticals Inc.,Gilead,Hospira,Inotrem,Janssen,Johnson & Johnson,Morphic,MSD,Mundipharma,Mylan,Pfizer,Roche,Sandoz,Sublimity Therapeutics,Takeda,Teladoc Health,TiGenix,UCB Inc.,Vial,and Vifor; lecture fees from AbbVie,Amgen,Ferring Pharmaceuticals Inc.,Gilead,Janssen,Mylan,Pfizer,and Takeda.
BES reports research grants from Janssen and Bristol Myers Squibb; consulting fees from AbbVie,Abivax,Adiso Therapeutics,Agomab,Alimentiv,Amgen,AnaptysBio,AstraZeneca,Biora Therapeutics,Boehringer Ingelheim,Bristol Myers Squibb,Celltrion,Ensho Therapeutics,Equillium,Ei Lilly and Company,Enthera,Enveda Biosciences,Evommune,Ferring,Fzata,Galapagos,Genentech,Gilead Sciences,GlaxoSmithKline,Gossamer Bio,Imhotex,Index Pharmaceuticals,Innovation Pharmaceuticals,Janssen,Johnson & Johnson,Kaleido,Kallyope,Merck & Co.,Microba,Microbiotica,Mitsubishi Tanabe Pharma,Mobius Care,Morphic Therapeutics,MRM Health,Nexus Therapeutics,Immunyx Therapeutics,Nimbus Discovery,Odyssey Therapeutics,Palisade Bio,Pfizer,Progenity,Prometheus Biosciences,Prometheus Laboratories,Protagonist Therapeutics,Q32 Bio,Rasayana Therapeutics,Recludix Therapeutics,Reistone Biotherapeutics,Sanofi,Sorriso Pharmaceuticals,Spyre Therapeutics,Surrozen,Target RWE,Takeda,Teva,Theravance Biopharma,TLL Pharmaceutical,TR1X,Union Therapeutics,Ventyx Biosciences; lecture fees from AbbVie,Abivax,Bristol Myers Squibb,Celltrion,Ei Lilly and Company,Janssen,Mitsubishi Tanabe Pharma,Pfizer,and Takeda; support for attending meetings and/or travel from Ei Lilly and Company,Janssen,and Takeda; participation on advisory board for Agomab and Amgen; stock or stock options from Ventyx Biosciences; medical writing/editorial support for AbbVie,Abivax,Bristol Myers Squibb,Celltrion,Eli Lilly and Company,Janssen,Merck & Co.,Pfizer,Ventyx Biosciences,Morphic Therapeutics,Takeda,and Alimentiv.
RP reports advisory/speaker/consulting fees from Abbott,AbbVie,Abbivax,Alimentiv (formerly Robarts),Amgen,AnaptysBio,Arena Pharmaceuticals,AstraZeneca,Biogen,Boehringer Ingelheim,Bristol-Myers Squibb,Celgene,Celltrion,Cosmos Pharmaceuticals,Eisai,Elan,Eli Lilly,Ferring,Galapagos,Fresenius Kabi,Genentech,Gilead Sciences,Glaxo-Smith Kline,JAMP Bio,Janssen,Merck,Mylan,Novartis,Oppilan Pharma,Organon,Pandion Pharma,Pendopharm,Pfizer,Progenity,Prometheus Biosciences,Protagonist Therapeutics,Roche,Sandoz,Satisfai Health,Shire,Sublimity Therapeutics,Spyre Therapeutics,Takeda Pharmaceuticals,Theravance Biopharma,Trellus,Union Biopharma,Viatris,Ventyx,UCB
BGF reports consulting fees from AbbVie,Abivax,Adiso,AgomAB Therapeutics,Allianthera,Amgen,AnaptysBio,Arena Pharma,Avoro Capital Advisors,Atomwise,,BioJamp,Biora Therapeutics,Blackbird Laboratories,Boehringer-Ingelheim,Boxer Capital,Celsius Therapeutics,Celgene/BMS,Connect BioPharma,Cytoki,Disc Medicine,Duality,EcoR1,Eli Lilly,Equillium,Ermium,First Wave,Forbion,Galapagos,Galen Atlantica,Genentech/Roche,Gilead,Gossamer Pharma,GSK,Hinge Bio,Index Pharma,Imhotex,Immunic Therapeutics,Intercept,JAKAcademy,Janssen,Japan Tobacco Inc.,Kaleido Biosciences,Klick Health,Landos Biopharma,Lenczner Slaght,LifeSci Capital,Lument AB,Mage Biologics,Mestag,Millennium,MiroBio,Monte Rose Tx,Morgan Lewis,Morphic Therapeutics,Mylan,Nexys Therapeutics,Nimbus Therapeutics,OM Pharma,OrbiMed Origo BioPharma,Orphagen,Pandion Therapeutics,Pendopharm,Pfizer,Prometheus Therapeutics and Diagnostics (Merck),Progenity,Protagonist,PTM Therapeutics,Q32 Bio,Rebiotix,REDX,Roche,Roivant/Televant,Sandoz,Sanofi,Seres Therapeutics,Silverback Therapeutics,Sobi,Spyre Therapeutics,Surrozen Inc.,Synedgen,Takeda,Teva,Thelium,Tigenix,Tillotts,Triastek,Ventyx; lecture fees from Takeda,Janssen,and AbbVie; participation on advisory board for AbbVie,AnaptysBio,Boehringer-Ingelheim,Celgene/BMS,Eli Lilly,Genentech/Roche,Janssen,Merck,MiroBio,Origo BioPharma,Pfizer,REDX Pharma,Sanofi,Takeda,Teva,Ecor1Capital,Morphic,GSK; stock or stock options from Evida,EnGene,and Connect Biopharma.
VJ reports consulting fees and participation on advisory board for AbbVie,Alimentiv,Altrubio,Amgen,AnaptysBio,Arena pharmaceuticals,Asahi Kasei Pharma,Asieris,Astra Zeneca,BiomeBank,Boehringer Ingelheim,Bristol Myers Squibb,Calluna Pharma,Celltrion,Eli Lilly,Endpoint Health,Ensho Therapeutics,Enthera,Exeliom Biosciences,Ferring,Flagship Pioneering,Fresenius Kabi,GlaxoSmithKline,Genentech,Gilead,Janssen,Merck,MRM Health,Nxera Therapeutics,Pandion,Pendopharm,Pfizer,Protagonist,Reistone Biopharma,Roche,Roivant,Sandoz,Sanofi,Second Genome,Sorriso,Spyre Therapeutics,Takeda,Teva,Tillotts,Ventyx,Vividion; speaker fees from AbbVie,Ferring,Bristol Myers Squibb,Galapagos,Janssen,Pfizer,Takeda,Tillotts,and Fresenius Kabi.
CM reports consulting fees from AbbVie,Alimentiv,Amgen,AVIR Pharma Inc,Bristol Myers Squibb,Celltrion,Domain Therapeutics,Eupraxia,Eli Lilly,Ferring,Forte Biosciences,Fresenius Kabi,Gilead,Janssen,McKesson,Mirador Therapeutics,Pendopharm,Pfizer,Prometheus Biosciences Inc.,Roche,Sanofi,Takeda,Tillotts Pharma; speaker's fees from AbbVie,Amgen,AVIR Pharma Inc,Alimentiv,Bristol Myers Squibb,Eli Lilly,Ferring,Fresenius Kabi,Janssen,Merck,Organon,Pendopharm,Pfizer,Sanofi,Takeda,Tillotts Pharma; royalties from Springer Publishing; research support from AbbVie,Eli Lilly,Ferring,Pfizer.