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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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For Inflectra® (infliximab) Prescribing Information for Great Britain click here.
For Inflectra® (infliximab) Prescribing Information for Northern Ireland click here
Adverse event reporting information can be found at the bottom of the page.

PROSIT-BIO Study design

The largest prospective study of CD and UC patients treated with Inflectra/CT-P13* (infliximab) to date.1

A prospective, nationwide, multicentre, observational study to evaluate Inflectra/CT-P13* (infliximab) either in IBD patients naïve to anti-TNF-a, previously exposed to anti-TNF-a, or switched from Remicade®.†1

​​​​​​​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. Secondary endpoints were, first, the efficacy, evaluated both in terms of clinical remission/response and treatment persistency; second, the immunogenicity evaluated as the occurence of infusion reactions and loss of response; and third, predictive factors of safety and efficacy.1

Study design

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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*CT-P13 is marketed under different brand names including Inflectra and REMSIMA®.
†Remicade® is a registered trademark of MSD.
ՖPrimary failure to CT-P13 was defined as no or minor clinical response at 8 weeks after the induction regimen or deterioration of clinical condition leading to surgery, early therapy change, or withdrawal. Loss of response was studied among responders at Week 8 using time-to-event methods for censored observations (i.e., patients withdrawn from the study because of AEs, and patients who had not lost response on the final data collection date, were considered “censored”).
ßEstimated efficacy was calculated using time-to-event methods for censored observations up to 32 weeks from the beginning of therapy.
ёEvaluation of safety in terms of rate of SAEs along the first year since the introduction of the CT-P13 biosimilar in Italy. 


#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.
CD=Crohn’s disease; UC=Ulcerative colitis; IBD=Inflammatory bowel disease; TNF=Tumour necrosis factor; SAE=Serious adverse event; AE=Adverse event.
References
  1. Fiorino G, et al. Inflamm Bowel Dis 2017. 23:233–243.
PP-IFA-GBR-0501. September 2021

Quick Links

  • GONCZI L et al

  • Study 3.4

  • NOR-SWITCH safety

  • NOR-SWITCH efficacy

  • PROSIT-BIO safety

  • PROSIT-BIO efficacy

  • PROSIT-BIO study design

  • Switch studies

  • Paediatric studies

  • Induction & Maintenance

  • Inflammatory bowel disease

Learn about the mechanism of action of Infliximab.

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