Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

Giammarco Mocci
,
Antonio Tursi
ORCID logo ,
Francesca Maria Onidi
,
Paolo Usai-Satta
ORCID logo ,
Giovanni Mario Pes
ORCID logo ,
Maria Pina Dore
* ORCID logo
Version 1 : Received: 19 January 2024 / Approved: 19 January 2024 / Online: 19 January 2024 (14:43:02 CET)

A peer-reviewed article of this Preprint also exists.

Mocci, G.; Tursi, A.; Onidi, F.M.; Usai-Satta, P.; Pes, G.M.; Dore, M.P. Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms. J. Clin. Med. 2024, 13, 1519. Mocci, G.; Tursi, A.; Onidi, F.M.; Usai-Satta, P.; Pes, G.M.; Dore, M.P. Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms. J. Clin. Med. 2024, 13, 1519.

Abstract

Inflammatory bowel diseases, comprising Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, relapsing and remitting immune-mediated inflammatory diseases affecting the gastrointestinal tract. Ustekinumab (UST) is a monoclonal antibody blocking the p40 subunit of the anti-interleukin (IL) 12/23. Pivotal trials (CERTIFI and UNITI-IM for CD, UNIFI for UC) established the efficacy of UST for the induction and maintenance of remission in both CD and UC, with the most favorable results in naïve patients to biologics. In recent years, a wealth of ‘real-world’ data has emerged supporting positive clinical, endoscopic, and histological outcomes in patients treated with UST, as well as reassuring safety data. More recently, the results of the first head-to-head trials of UST and tumor necrosis factor (TNF) antagonists have been reported. Moreover, a number of studies exploring the role of UST in specific clinical settings, such as perianal CD, postoperative complications and recurrence, extraintestinal manifestations, chronic antibiotic-refractory pouchitis, and pregnancy, have been reported. This review explores results reported to date on UST, including those from pivotal trials, real-world data, and emerging studies regarding therapeutic drug monitoring and immunogenicity. The safety profile of UST was also reviewed.

Keywords

crohn’s disease; inflammatory bowel diseases; mucosal healing; safety; remission; ulcerative colitis; ustekinumab

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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