Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec 1;33(1S Suppl 1):e783-e788.
doi: 10.1097/MEG.0000000000002256.

Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease

Sebastiaan Ten Bokkel Huinink  1 , Vince Biemans  2   3 , Marjolijn Duijvestein  4 , Marieke Pierik  3 , Frank Hoentjen  2 , Rachel L West  5 , Christien J van der Woude  1 , Annemarie C de Vries  1
Affiliations

Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease

Sebastiaan Ten Bokkel Huinink et al. Eur J Gastroenterol Hepatol. .

Abstract

Background and aim: Re-induction with intravenous ustekinumab after secondary loss of response in Crohn's disease is a relatively new strategy to regain efficacy. This real-world cohort study aimed to evaluate its effectiveness and safety.

Methods: Crohn's disease patients with loss of response after initial response to ustekinumab and treated with a second intravenous dose of ustekinumab were included. Clinical, biochemical and endoscopic data were collected. Primary outcome was drug survival. Secondary effectiveness outcomes included clinical remission, primary nonresponse and adverse events.

Results: In total, 31 Crohn's disease patients were included after re-induction with intravenous ustekinumab. All patients had failed prior biologic therapy, that is 77% were exposed to two or more antitumor necrosis factor agents and 65% were exposed to vedolizumab prior to initiation of ustekinumab treatment. Median treatment duration between initial treatment and re-induction with intravenous ustekinumab was 11.1 months (interquartile range 6.9-19.5). Ustekinumab therapy after a second dose of intravenous ustekinumab was maintained in 74 and 71% of the patients at weeks 20 and 52. Clinical remission rates after re-induction at weeks 8, 20 and 52 were 37, 56 and 45%, respectively. Nonresponse occurred in 16% of the patients. Adverse events were reported in four patients.

Conclusions: Re-induction with intravenous ustekinumab after secondary loss of response results in continuation of ustekinumab treatment for at least 1 year in almost three-quarters of patients and in clinical remission in half of patients after 1 year. Therefore, ustekinumab re-induction may be considered an important rescue treatment option in patients with refractory Crohn's disease.

Trial registration: ClinicalTrials.gov NCT03782376.

PubMed Disclaimer

References

    1. Lamb YN, Duggan ST. Ustekinumab: a review in moderate to severe Crohn’s disease. Drugs 2017; 77:1105–1114.
    1. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, et al.; UNITI–IM-UNITI Study Group. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2016; 375:1946–1960.
    1. Kopylov U, Hanzel J, Liefferinckx C, De Marco D, Imperatore N, Plevris N, et al. Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous maintenance therapy. Aliment Pharmacol Ther 2020; 52:135–142.
    1. Liefferinckx C, Verstockt B, Gils A, Noman M, Van Kemseke C, Macken E, et al.; Belgian Inflammatory Bowel Disease Research and Development Group [BIRD group]. Long-term clinical effectiveness of ustekinumab in patients with Crohn’s disease who failed biologic therapies: a national cohort study. J Crohns Colitis 2019; 13:1401–1409.
    1. Ma C, Fedorak RN, Kaplan GG, Dieleman LA, Devlin SM, Stern N, et al. Long-term maintenance of clinical, endoscopic, and radiographic response to ustekinumab in moderate-to-severe Crohn’s disease: real-world experience from a multicenter cohort study. Inflamm Bowel Dis 2017; 23:833–839.

Associated data