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
. 2019 Jul-Aug;32(4):392-399.
doi: 10.20524/aog.2019.0377. Epub 2019 Apr 22.

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Antonio Tursi  1 , Giammarco Mocci  2 , Roberto Faggiani  3 , Leonardo Allegretta  4 , Nicola Della Valle  5 , Giacomo Forti  6 , Marilisa Franceschi  7 , Antonio Ferronato  7 , Sara Gallina  3 , Tiziana Larussa  8 , Francesco Luzza  8 , Roberto Lorenzetti  9 , Antonio Penna  10 , Stefano Rodino  11 , Ladislava Sebkova  11 , Angelo Lauria  12 , Simona Piergallini  13 , Giuseppe Pranzo  14 , Cristina Ricciardelli  15 , Costantino Zampaletta  3 , Walter Elisei  16 , Marcello Picchio  17
Affiliations

Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Antonio Tursi et al. Ann Gastroenterol. 2019 Jul-Aug.

Abstract

Background: The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers.

Methods: Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety.

Results: One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission.

Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.

Keywords: Biosimilar; CT-P13; Crohn’s disease; infliximab; ulcerative colitis.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None

Figures

Figure 1
Figure 1
Estimated cumulative clinical remission probability during follow up in patients with ulcerative colitis (UC) or Crohn’s disease (CD). Log-rank test
See this image and copyright information in PMC

References

    1. Dignass A, Eliakim R, Magro F, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1:definitions and diagnosis. J Crohns Colitis. 2012;6:965–990. - PubMed
    1. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2:current management. J Crohns Colitis. 2012;6:991–1030. - PubMed
    1. Lichtenstein GR, Abreu MT, Cohen R, Tremaine W American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006;130:940–987. - PubMed
    1. Norum J, Koldingsnes W, Aanes T, Antonsen MA, Florholmen J, Kondo M. The economic burden of TNFαinhibitors and other biologic treatments in Norway. Clinicoecon Outcomes Res. 2011;3:73–78. - PMC - PubMed
    1. Rutgeerts P, Van Assche G, Vermeire S. Review article:Infliximab therapy for inflammatory bowel disease—seven years on. Aliment Pharmacol Ther. 2006;23:451–463. - PubMed

LinkOut - more resources