Why the Assay Matters in Model-Informed Precision Dosing: An Example of Ustekinumab in Crohn’s Disease

Conflict of interest

Thierry Dervieux is employed at Prometheus Laboratories. Nick Geukens is a co-founder and shareholder of Hemastatx, a KU Leuven spin-off company. Bram Verstockt received research support from AbbVie, Biora Therapeutics, Celltrion, Landos, Pfizer, Sanofi, Sossei Heptares/Nxera, and Takeda; speaker’s fees from AbbVie, Agomab, Alfasigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lily, Falk, Ferring, Galapagos, Materia Prima, Johnson and Johnson, Pfizer, Sandoz, Takeda, Tillots Pharma, Truvion, and Viatris; consultancy fees from AbbVie, Agomab, Alfasigma, Alimentiv, Anaptys Bio, Applied Strategic, AstraZeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, Bristol Myers Squibb, Domain Therapeutics, Eli Lily, Galapagos, Guidepont, Landos, Merck, Mirador Therapeutics, Mylan, Nxera, Inotrem, Ipsos, Johnson and Johnson, Onco3R, Pfizer, Sandoz, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Takeda, Tillots Pharma, and Viatris; and stock options from Vagustim and Thetis Pharma. Marc Ferrante received research grants from AbbVie, Biogen, EG Pharma, Janssen, Pfizer, Takeda, and Viatris; consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, MRM Health, Merck Sharp and Dohme, Pfizer, Takeda, and ThermoFisher; and speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Dr Falk, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare, and Viatris. Séverine Vermeire received speakers’ and/or consultancy fees from AbbVie, Abivax, AbolerlsPharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Biora Therapeutics, BMS, Boehringer Ingelheim, Celgene, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech Roche, Gilead, GSK, Hospira, lmidomics, Janssen, Johnson&Johnson, Lilly, Materia Prima, Mestag Therapeutics, Microbiotica, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Surrozen, Takeda, Theravance, Tillots Pharma AG, VectivBio, Ventyx, and Zealand Pharma. Séverine Vermeire is currently the rector of KU Leuven (2025–29). Erwin Dreesen received consultancy fees from Alimentiv and argenx; lecture fees from Celltrion and Galapagos; and financial support from Celltrion, Janssen, Pfizer, Prometheus, R-Biopharm, and Sandoz, with all honoraria/fees being paid to KU Leuven and not to any personal account of Erwin Dreesen. Wei Zhang and Zhigang Wang have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

The Ethics Committee Research (EC Research) of University Hospitals Leuven (UZ Leuven) approved the study (S53684, S65776).

Consent to participate

Informed consent was obtained from all patients included in the study.

Consent for publication

Not applicable.

Availability of data and material

The individual participant data underlying the reported results were provided by collaborating researchers and are not publicly available because of privacy or institutional restrictions. Access to the data may be granted upon reasonable request and with permission from the original data custodians.

Code availability

The NONMEM model code supporting this study is provided within the ESM.

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