Cure8 research brief
Pharmacokinetics affect how well biologic drugs work for IBD. Better PK data could help explain why many patients have inadequate responses and could inform personalized dosing for IL-23p19 inhibitors used in Crohn’s disease and ulcerative colitis.
Clinicians treating IBD, researchers studying biologic drug PK or personalized dosing, and patients on or considering IL-23p19 biologics (risankizumab, guselkumab, mirikizumab).
This systematic review summarizes published pharmacokinetic (PK) studies of IL-23p19 inhibitors across immune-mediated inflammatory diseases (IMIDs), with a focus on available data for inflammatory bowel disease (IBD).
The review identified 21 studies covering risankizumab (9), guselkumab (6), tildrakizumab (3), and mirikizumab (3), and included populations such as healthy volunteers, psoriasis, psoriatic arthritis, Crohn’s disease (CD), and ulcerative colitis (UC).
Only one study specifically examined an IBD pediatric UC group (mirikizumab), highlighting sparse IBD-specific PK data.
Key findings reported include generally similar risankizumab PK parameters (dose-normalized Cmax and AUC, volumes of distribution, clearance) across CD and UC, rising trough levels over consecutive dosing intervals in CD and UC (opposite trend in other IMIDs), and covariate associations limited to albumin in UC and body weight in CD.
The authors conclude that limited PK data and lack of subphenotype-specific IBD studies make it difficult to define population variability and to develop personalized dosing strategies for IL-23p19 inhibitors in IBD.
This entry is based on the article abstract (systematic review) in Clinical Pharmacokinetics. The review highlights limited IBD-specific PK evidence and calls for more studies; it does not provide new clinical recommendations or trial results.
Review the original publication for the complete reporting, methods, and context.
Conflict statement: Declarations. Conflict of interest: The corresponding author confirms on behalf of all authors that there have been no involvements that might raise the question of bias in the work reported or in the conclusions, implications, or opinions stated. RJK is shareholder of Insight RX, San Francisco, CA, USA. MCD reports receiving consultancy and advisory fees from AbbVie, Abivax, AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Meyer Squibb, Celltrion, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Janssen Pharmaceuticals, Johnson and Johnson, Merck, Pfizer Inc, Prometheus Labs, Sanofi, Spyre, and Takeda Pharmaceuticals, and licensing fees from Takeda Pharmaceuticals. JT has received consulting/advisory board fees from Abbvie, Pfizer, Janssen, Tillots Pharma, Takeda, Sandoz and Lilly; grant support from Janssen and Abbvie. RA has served as a speaker, consultant, or received research grants from AbbVie, Abivax, AlfaSigma, AstraZeneca, Bristol-Myers Squibb, Celltrion Healthcare, Galapagos, Johnson & Johnson, Lilly, MSD Sharp & Dohme, Pfizer, and Takeda Pharma. PMa is a full-time employee of Ionis and may hold Ionis stock or options. ED received consultancy fees from Alimentiv and Argenx; lecture fees from Celltrion and Galapagos; and financial support from Celltrion, Janssen, Pfizer, Prometheus Biosciences, R-Biopharm, and Sandoz, outside the submitted work, with all honoraria/fees being paid to KU Leuven and not to any personal account of ED. GD received a grant from Royal DSM, advisory board fees from Pharmacosmos and Astra-Zeneca, and speakers fee from Abbvie. HJV received grants paid to the University Medical Center Groningen from Albireo/Ipsen and Mirum and consultancy fees paid to the University Medical Center Groningen from Albireo/Ipsen, Intercept, Mirum, Orphalan, ProQR and Vertex, all outside of the submitted work. ARB reports receiving research grants from Janssen Pharmaceuticals and received speaker’s and advisory board fees from AbbVie and Ferring Pharmaceuticals, outside the submitted work. All other authors have no conflicts of interest to declare. Availability of data and material: Not applicable. All available data are included within the manuscript and supplementary files. Ethics approval: Not applicable. Consent to participate: Not applicable. Consent for publication: Not applicable. Code availability: Not applicable. Author contributions: Conceptualization: PM and ARB. Data curation: IAP, AG, PM and ARB. Formal analysis: IAP, AG and PM. Funding acquisition: PM and ARB. Investigation: all authors. Methodology: IAP, AG, PM and ARB. Project administration: IAP and ARB. Data acquisition: IAP, AG and PM. Resources: IAP, AG and PM. Sources: NA. Supervision: PM and ARB. Validation: all authors. Visualization: IAP and AG. Writing—original draft: IAP, AG, PM and ARB. Writing—review and editing: all authors. All authors read and approved the final version.
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