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
. 2022 Feb 14:15:17562848211072412.
doi: 10.1177/17562848211072412. eCollection 2022.

Effectiveness of ustekinumab in patients with refractory Crohn's disease: a multicentre real-life study in Italy

Maria Lia Scribano  1 , Annalisa Aratari  2 , Benedetto Neri  3 , Cristina Bezzio  4 , Paola Balestrieri  5 , Valentina Baccolini  6 , Giuliano Falasco  7 , Caterina Camastra  7 , Paolo Pantanella  7 , Rita Monterubbianesi  7 , Alessandro Tullio  5 , Simone Saibeni  4 , Claudio Papi  2 , Livia Biancone  3 , Rocco Cosintino  7 , Roberto Faggiani  7
Affiliations

Effectiveness of ustekinumab in patients with refractory Crohn's disease: a multicentre real-life study in Italy

Maria Lia Scribano et al. Therap Adv Gastroenterol. .

Abstract

Background: The effectiveness of ustekinumab in patients with refractory Crohn's disease (CD) has been investigated in several real-world studies. However, very few data concerning the real-life experience in Italy have been reported. Therefore, this study assessed the effectiveness of ustekinumab in a large cohort of Italian patients with refractory CD.

Methods: All patients who had started on ustekinumab after failure of or intolerance to antitumour necrosis factor-α (TNF-α) treatment at five tertiary centres between November 2018 and February 2020 were retrospectively enrolled. The coprimary outcome was corticosteroid-free clinical remission, defined as a Harvey-Bradshaw Index (HBI) score of ⩽4, at weeks 26 and 52. The secondary outcomes were changes in the HBI and C-reactive protein (CRP) values at weeks 8, 26, and 52 from baseline and the normalization of CRP in patients with initially abnormal values.

Results: Totally, 140 patients who had previously received at least one anti-TNF-α agent were enrolled; 40.0% received two anti-TNF-α agents and 20.0% received vedolizumab. At baseline, 108 patients (77.1%) had HBI scores of >4; of these, 56.5% and 58.3% achieved corticosteroid-free clinical remission at weeks 26 and 52, respectively. Significant decreases in HBI and CRP values were observed at weeks 8, 26, and 52 in the entire study cohort (all p < 0.0001). The CRP values were normalized in 34.9%, 37.8%, and 49.3% of the patients by weeks 8, 26, and 52, respectively. The baseline HBI score of ⩾8 was a negative predictor of corticosteroid-free clinical remission at week 52 (odds ratio: 0.21, 95% confidence interval: 0.08-0.56, p = 0.002). The probability of remaining on ustekinumab after 52 weeks was 92.1%. Eleven (7.9%) patients discontinued ustekinumab (three for adverse events).

Conclusion: Our study findings confirm the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy.

Keywords: Crohn’s disease; effectiveness; refractory; ustekinumab.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MLS: advisory board and/or lecture fees from AbbVie, Celltrion, Janssen, Pfizer, and Takeda. CB: lecture fees from Takeda, AbbVie, and Janssen. SS: advisory board and lecture fees from Arena, Gilead, Janssen, Takeda, and AbbVie. CP: consultancy fees and/or educational grants from AbbVie, MSD, Takeda, Pfizer, Janssen-Cilag, Chiesi, Sofar, Ferring, and Zambon. LB: speaker fees from Ferring, AbbVie, Janssen, and Zambon. The other authors declare no conflict of interest.

Figures

Figure 1.
Figure 1.
Flowchart of patient progress through the study. *Allergic reaction. **Intense arthralgia.
Figure 2.
Figure 2.
Clinical effectiveness of ustekinumab at weeks 8, 26, and 52. Corticosteroid-free clinical remission is shown for the cohorts of patients with HBI scores of >4 (108/140, 77.1%) and ⩽4 (32/140, 22.9%) at baseline. A corticosteroid-free clinical response is only shown for the cohort of patients with an HBI score of >4 at baseline.
Figure 3.
Figure 3.
Kaplan–Meier survival curve showing persistence with ustekinumab therapy in the study population.
See this image and copyright information in PMC

References

    1. Torres J, Mehandru S, Colombel JF, et al.. Crohn’s disease. Lancet 2017; 389: 1741–1755. - PubMed
    1. Orlando A, Armuzzi A, Papi C, et al.. The Italian Society of Gastroenterology (SIGE) and the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) clinical practice guidelines: the use of tumor necrosis factor-alpha antagonist therapy in inflammatory bowel disease. Dig Liver Dis 2011; 43: 1–20. - PubMed
    1. Nielsen OH, Ainsworth MA. Tumor necrosis factor inhibitors for inflammatory bowel disease. N Engl J Med 2013; 369: 754–762. - PubMed
    1. Lichtenstein GR, Feagan BG, Cohen RD, et al.. Infliximab for Crohn’s disease: more than 13 years of real-world experience. Inflamm Bowel Dis 2018; 24: 490–501. - PMC - PubMed
    1. Ding NS, Hart A, De Cruz P. Systematic review: predicting and optimising response to anti-TNF therapy in Crohn’s disease – algorithm for practical management. Aliment Pharmacol Ther 2016; 43: 30–51. - PubMed