Ustekinumab for treating ulcerative colitis: an expert opinion

ABSTRACT

Introduction

Biologic agents have revolutionized the therapeutic management of ulcerative colitis. Anti-tumor necrosis factor agents were the first biologic drugs used to induce and maintain remission in this inflammatory bowel disease. Recently, another biologic option, ustekinumab, has become available for the treatment of moderate-to-severe ulcerative colitis.

Areas covered

In this article, the authors review the literature on the efficacy and safety of ustekinumab in the context of current biologic agents used for the management of this disease. The potential role of ustekinumab in the treatment paradigm of the disease is also discussed.

Expert opinion: The UNIFI trial has demonstrated the efficacy and safety of ustekinumab in induction and maintenance phases of treatment for ulcerative colitis. Ustekinumab may provide clinical benefit in a range of settings in patients with ulcerative colitis, even for those with multiple treatment failures, which are relatively common in daily clinical practice. Future clinical trials should compare the efficacy of ustekinumab with existing biologic agents in the management of ulcerative colitis.

KEYWORDS:

• Interleukin 12/23 inhibitor
• inflammatory bowel disease
• ulcerative colitis
• ustekinumab

Article highlights

• Ustekinumab, an antibody to the p40 subunit of interleukin-12 and −23, is an emerging therapeutic option for patients with ulcerative colitis.

• The UNIFI trial has demonstrated the efficacy of ustekinumab in moderate-to-severe ulcerative colitis with a favorable safety profile.

• Two flowcharts, the first for biologic-naive patients and the second for patients with a history of failure of anti-tumor necrosis factor agents, are proposed and discussed.

This box summarizes key points contained in the article.

Acknowledgments

Medical writing support and editorial assistance was provided by Luigia Atorino, PhD, Edra S.p.A, Milan, Italy, and unconditionally funded by Janssen-Cilag S.p.A.

Declaration of interest

L. B. fees grant for speaker from Ferring, Abbvie, Janssen and Zambia; S.A. served as a speaker, consultant, and/or advisory board member for the following organisations: AbbVie, MSD, Takeda, Janssen, Pfizer, Recordati, Sandoz, Enthera; A.A. served as Consultant for: AbbVie, Allergan, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Ferring, Gilead, Janssen, Lilly, MSD, Mylan, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda; received lecture fees from: AbbVie, Amgen, AstraZeneca, Biogen, Chiesi, Ferring, Janssen, MSD, Mitsubishi Tanabe, Nikkiso, Pfizer, Samsung Bioepis, Sandoz, Takeda, Tigenix; received research grants from: MSD, Takeda, Pfizer; F.C. served as advisory board member/or received lecture grants from Janssen-Cilag, Pfizer, Vitaphor, AbbVie, Chiesi and Takeda Pharmaceuticals; S.D. reports consultancy fees from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ely Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, IQVIA, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., and Vifor; P.G. reports consultancy fees from: Janssen, Abbvie, Pfizer, Celgene, Takeda, Ferring, MSD, Alfa Wasserman, Amgen; served as speaker for Abbvie, Janssen, Takeda, Ferring, Msd, Sofar, Chiesi; F. R. served as advisory board member for AbbVie, Janssen-Cilag, MSD, Pfizer and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Chiesi, Janssen-Cilag, MSD, Pfizer, Ferring, Sofar and Takeda Pharmaceuticals; M.L.S. has served as an advisory board member and/or a speaker for Abbvie, Celltrion, Janssen, Pfizer, Takeda; A. O. served as advisory board member for AbbVie, Janssen-Cilag, MSD, Pfizer and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Chiesi, Janssen-Cilag, MSD, Pfizer, Sofar and Takeda Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This editorial project was supported by Janssen-Cilag S.p.A.