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

Overview

Journal Ann Gastroenterol

Specialty Gastroenterology

Date 2019 Jul 3

PMID 31263362

Citations 6

Authors

Antonio Tursi

Giammarco Mocci

Roberto Faggiani

Leonardo Allegretta

Nicola Della Valle

Giacomo Forti

Marilisa Franceschi

Antonio Ferronato

Sara Gallina

Tiziana Larussa

Francesco Luzza

Roberto Lorenzetti

Antonio Penna

Stefano Rodino

Ladislava Sebkova

Angelo Lauria

Simona Piergallini

Giuseppe Pranzo

Cristina Ricciardelli

Costantino Zampaletta

Walter Elisei

Marcello Picchio

Affiliations

Soon will be listed here.

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.

Citing Articles

The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: a systematic review and meta-analysis.

Hu X, Tang X, Li L, Luo L, He X, Yan Q BMC Gastroenterol. 2024; 24(1):406.

PMID: 39533176 PMC: 11555959. DOI: 10.1186/s12876-024-03480-9.

Real-world data on the infliximab biosimilar CT-P13 (Remsima) in inflammatory bowel disease.

Huguet J, Cortes X, Bosca-Watts M, Aguas M, Maroto N, Marti L World J Clin Cases. 2022; 9(36):11285-11299.

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Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series.

Larussa T, Basile A, Palleria C, Iannelli C, Vero A, Giubilei L Med Pharm Rep. 2021; 94(3):289-297.

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The Reality of Patient-Reported Outcomes of Health-Related Quality of Life in an Italian Cohort of Patients with Inflammatory Bowel Disease: Results from a Cross-Sectional Study.

Larussa T, Flauti D, Abenavoli L, Boccuto L, Suraci E, Marasco R J Clin Med. 2020; 9(8).

PMID: 32731482 PMC: 7464775. DOI: 10.3390/jcm9082416.

Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies.

Lee S, Baek K, Lee S, Lee Y, Park J, Lee S BioDrugs. 2020; 34(4):513-528.

PMID: 32356239 PMC: 7223987. DOI: 10.1007/s40259-020-00421-2.

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