What question did this study set out to answer?

To assess the short-term safety and efficacy of the infliximab biosimilar CT-P13 for remission induction in patients with Crohn's disease and ulcerative colitis.

May 12, 2015Zeitschrift für Gastroenterologie

Biosimilar Infliximab in inflammatory bowel diseases: First interim results from a prospective nationwide observational cohort

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Authors

KGK GecseAmsterdam University Medical Centers KFK FarkasUniversity of Szeged BLBarbara D. LovászSemmelweis University

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Implication

Prospective cohort study demonstrates significant disease reduction with biosimilar infliximab in inflammatory bowel disease, indicating effective induction of clinical remission.

Key Points

To assess the short-term safety and efficacy of the infliximab biosimilar CT-P13 for remission induction in patients with Crohn's disease and ulcerative colitis.
Conducted a prospective, nationwide, multicentre observational cohort study in Hungary enrolling 90 consecutive patients with inflammatory bowel disease (57 with Crohn's disease and 33 with ulcerative colitis).
Monitored disease activity using CDAI, PDAI, and Mayo/partial Mayo (pMAYO) scores at each visit, alongside biochemical markers at least every 3 months and serum drug trough and antibody levels at weeks 0, 12, 24, and 52.
Crohn's disease activity index (CDAI) scores significantly decreased from a baseline mean of 289 (SD: 107) after 2 and 6 weeks of induction therapy (p < 0.001, ANOVA-Scheffe).
Ulcerative colitis mean pMAYO scores decreased significantly from 6.4 (SD: 2.6) at baseline to 3.7 at week 2 and 3.6 at week 6, paralleled by decreasing trends in C-reactive protein.
Four allergic reactions occurred during follow-up, all observed exclusively in patients with prior exposure to anti-TNF agents.

Cite This Study

Gecse et al. (2015) studied this question.

synapsesocial.com/papers/6a830ad9c4b5dbf8331f293e https://doi.org/10.1055/s-0035-1551853

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Implication

Prospective cohort study demonstrates significant disease reduction with biosimilar infliximab in inflammatory bowel disease, indicating effective induction of clinical remission.

Biosimilar Infliximab in inflammatory bowel diseases: First interim results from a prospective nationwide observational cohort

Discussion

Member takes

Implication

Key Points

Cite This Study

Biosimilar Infliximab in inflammatory bowel diseases: First interim results from a prospective nationwide observational cohort

Discussion

Member takes

Implication

Key Points

Cite This Study

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