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Click here for Inflectra® (infliximab) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

PROSIT-BIO

Efficacy

The primary endpoint was the evaluation of safety in terms of rate of SAEs along the first year since the introduction of the CT-P13 biosimilar in Italy.1

A secondary endpoint was efficacy evaluated both in terms of clinical remissions/response and treatment persistency.

Evaluation of the secondary endpoints demonstrated no significant difference in the estimated probability of response between the 3 treatment groups (log-rank test, p=0.64).1

Secondary endpoints: Probability of response (KM estimates) or primary failure at 8 weeks# by subgroup (n=434).1​​​​​​​​​​​​​​

No significnat difference in the estimated probability of response was found between the 3 treatment groups (log-rank test, p=0.64).1
Created from Fiorino G, et al. 2017. 

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Crohn’s disease safety

Learn about the safety profile of Inflectra in patients with Crohn’s disease

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Crohn’s disease dosing

Learn about the dosing and administration of Inflectra in patients with Crohn’s disease

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#Data at the 8-week time point were calculated after the first 8 weeks; therefore 8 weeks actually represents 16 weeks from the start of treatment. 18.6% (74/399) of the overall cohort’s responders at Week 8 lost response during follow-up, which includes from Week 8 onward.
KM=Kaplan-Meier; SAE=Serious adverse event; AE=Adverse event.
References
  1. Fiorino G, et al. Inflamm Bowel Dis 2017. 23:233–243.
PP-IFA-GBR-0416. March 2021

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Learn about the mechanism of action of Infliximab.

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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PP-PFE-GBR-2688. December 2020

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