Ustekinumab as induction and maintenance therapy for ulcerative colitis – national extended follow-up and a review of the literature

ABSTRACT

Introduction

Ustekinumab use in ulcerative colitis had shown low adverse event and high persistence rates to 3 years via the UNIFI long-term extension study. Outcomes beyond 3 years have not been previously described. We describe the safety signals of the entire UNIFI Australian population beyond 3 years.

Methods

This retrospective multicenter observational cohort study recruited from all Australian UNIFI centers. The primary outcome was safety via adverse events. Secondary outcomes included the clinical relapse rate on ustekinumab, and the need to switch from ustekinumab to an alternate agent.

Results

There were 14 patients [11 male, mean age 47 (±14) years], with a median diagnosis of 10.8 (±4.5) years prior to UNIFI enrollment. Median follow-up was 298 weeks (5.7 years) (Interquartile range (IQR): 220–311 weeks). Within the long-term extension, there were three serious adverse events and one minor event. 42.9% (6/14) patients had clinical relapses, of which clinical remission was recaptured in 83.3% (5/6). 85.7% (12/14) persisted on ustekinumab in the long-term, with 7.1% (1/14) electively ceasing ustekinumab and 7.1% (1/14) changed from ustekinumab due to clinical relapse.

Conclusion

For moderate-to-severe UC in Australia, ustekinumab maintained efficacy beyond 3 years with a high persistence rate and no new safety signals.

Trial Registration

The trial is registered at ANZCTR (identifier: ACTRN12622001332718).

KEYWORDS:

• Ustekinumab
• ulcerative colitis
• drug safety
• persistence
• adverse events

Declaration of interests

SP has served as a consultant for Finch Therapeutics and has received speaker/advisory board fees from AbbVie, Dr Falk Pharma, Ferring, Janssen and Takeda. RWL reports personal fees from AbbVie, personal fees from Aspen, personal fees from Ferring, grants and personal fees from Hospira/Pfizer, grants and personal fees from Janssen, grants and personal fees from Takeda, grants from Shire, personal fees from Celgene, personal fees from Dr Falk Pharma, personal fees from Novartis, personal fees from MSD, personal fees from Chiesi, personal fees from BMS, personal fees from Glutagen, outside the submitted work. SC has received honoraria for Advisory Board participation, speaker fees, educational support and/or research support from: Abbvie, Amgen, BMS, Celltrion, Chiesi, DrFalk, Eli-Lilly, Ferring, Fresenius Kabi, GSK, Janssen, MSD, Novartis, Organon, Pfizer, Sandoz, and Takeda. 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

One reviewer declares the following paid consultancies, lecture fees for the past two years: Abbvie, Janssen, Takeda, Galapagos, Biogen, Celltrion, Lilly. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Authors contribution statement

John Chetwood was responsible for the study design, data acquisition, and creation of the draft manuscript. Sidhartha Gupta, Kavitha Subramanian, Peter De Cruz, Yoon An, Susan Connor, Melissa Kermeen, Sudarshan Paramsothy were responsible for data acquisition, and providing critical review of the manuscript. Rupert Leong was responsible for the study design, data acquisition and critical review of the manuscript

All authors contributed to the conception and design of the review article, were involved in writing the review article and revised it for intellectual content, and agreed on the manuscript changes the journal to which the article has been submitted

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2278686.

Additional information

Funding

This paper was not funded.