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. 2025 Oct 25:S1590-8658(25)01128-4.
doi: 10.1016/j.dld.2025.09.026. Online ahead of print.

Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data

Laurent Peyrin-Biroulet  1 , Maciej Nazar  2 , Anna Sheahan  3 , Anja Geldhof  4 , Ahlem Azzabi  5 , Filip Baert  6 , Charlotte Mailhat  7 , Hélène Rousseau  8 , Jean-François Rahier  9 , Laurent Beaugerie  10
Affiliations
Free article

Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data

Laurent Peyrin-Biroulet et al. Dig Liver Dis. .
Free article

Abstract

Background: Limited data are available from large, prospective cohort studies evaluating the long-term safety of ustekinumab in patients with Crohn's disease.

Aims: To evaluate the long-term safety profile of ustekinumab in adult patients with Crohn's disease.

Methods: RRA-20745 was an observational post-authorisation safety study. Data were derived from the I-CARE study (NCT02377258), a European prospective, observational, multi-centre cohort study. Malignancies, serious infections (including opportunistic infections and tuberculosis), and venous thromboembolism associated with hospitalisations were evaluated.

Results: Data for 878 patients with Crohn's disease who received ustekinumab (mean follow-up 37.8 months), were included (median age 37.4 years, 58.9 % female, 64.5 % incident ustekinumab users and 35.5 % prevalent users). There were 7 malignancies reported in 7 patients (by organ affected: skin, 3 patients [0.4 %], blood, lymph nodes, rectum, breast, 1 patient [0.1 %] each). Serious infections were reported by 16 (1.8 %) patients (6 prevalent users, 10 incident users). The most common serious infections were gastrointestinal (7 patients, 0.8 %), followed by pulmonary infections (3 patients, 0.3 %). 1 patient (0.1 %; prevalent cohort) reported a bacterial opportunistic infection. No patients reported tuberculosis or venous thromboembolism.

Conclusions: In the RRA-20745 observational cohort, ustekinumab had a safety profile consistent with that observed in clinical trials and available post-marketing data.

Trial registration number: NCT02377258.

Keywords: Infection; Malignancy; Prospective; Venous thromboembolism.

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Conflict of interest statement

Declaration of competing interest L.P-B. has received consulting fees from AbbVie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook Group, Biogen, BMS, Celltrion, Connect BioPharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galápagos, 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 Immunotherapeutics, Pandion Therapeutics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, TiGenix, Tillots, Viatris, VectivBio, Ventyx, YSOPIA; has received grants from Celltrion, Fresenius Kabi, Medac, MSD, Takeda; lecture fees from AbbVie, Alfasigma, Amgen, Arena, Biogen, Celltrion, Ferring, Galápagos, Genentech, Gilead, Janssen, Kern Pharma, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots, Viatris; and has received travel support from AbbVie, Alfasigma, Amgen, Celltrion, Connect Biopharma, Ferring, Galápagos, Genentech, Gilead, Gossamer Bio, Janssen, Lilly, Medac, Morphic, MSD, Pfizer, Sandoz, Takeda, Thermo Fischer, Tillots. M.N. is an employee of Johnson&Johnson. A.S. is an employee and shareholder of Johnson&Johnson. A.G. is an employee of J&J and holds company stock/stock options. A.A. is an employee of Johnson&Johnson and holds company stock/stock options. F.B. has received grant/research support from AbbVie, Amgen, EG, Janssen and Takeda; has received honoraria from AbbVie, Amgen, Arena, Celgene, Celltrion Ferring, Fresenius Kabi, Janssen, Merck Sharp & Dohme, Pfizer, and Takeda; and was on speaker bureaus for AbbVie, Celltrion, Eli Lilly, Ferring, Janssen, Merck Sharp & Dohme, Pfizer, and Takeda. C.M. has received honoraria from Janssen, AbbVie, and Celltrion. H.R. has no conflicts of interest. J.F.R. has received speaker fees from AbbVie, Amgen, Biogen, Celltrion, Falk, Ferring, MSD, Pfizer, and Takeda; has been a consultant for AbbVie, GSK, Hospira, Janssen, Mundipharma, MSD, Pfizer, and Takeda; and has received research grants from AbbVie and Takeda. L.B. received honoraria from Janssen, Takeda, and Viatris in 2022; and has nothing to declare in 2023 or 2024.

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