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J Crohns Colitis. 2016 Feb;10(2):133-40. doi: 10.1093/ecco-jcc/jjv220. Epub 2015 Dec 10.

Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

Author information

1
First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
2
First Department of Internal Medicine, University of Szeged, Szeged, Hungary.
3
Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
4
First Department of Medicine, Peterfy Hospital, Budapest, Hungary.
5
Second Department of Medicine, Zala County Hospital, Zalaegerszeg, Hungary.
6
Second Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary.
7
Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprém, Hungary.
8
Second Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
9
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Hungary.
10
Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary.
11
Department of Gastroenterology, Tolna County Teaching Hospital, Szekszárd, Hungary.
12
Department of Gastroenterology, Janos Hospital, Budapest, Hungary.
13
First Department of Medicine, University of Pécs, Pécs, Hungary.
14
Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary.
15
First Department of Internal Medicine, Semmelweis University, Budapest, Hungary lakatos.peter_laszlo@med.semmelweis-univ.hu.

Abstract

BACKGROUND AND AIMS:

Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking.

METHODS:

A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay.

RESULTS:

In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively.

CONCLUSIONS:

This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.

KEYWORDS:

Biosimilar; CT-P13; Crohn’s disease; efficacy; immunogenicity; inflammatory bowel diseases; infliximab; safety; ulcerative colitis

PMID:
26661272
DOI:
10.1093/ecco-jcc/jjv220
[Indexed for MEDLINE]

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