The largest prospective study of CD and UC patients treated with Inflectra®/CT-P13* (infliximab) to date22.

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®†22.

Although no direct comparison was performed, the safety profile of CT-P13* was in line with that of Remicade®†22.

Study design22

PROSIT-BIO Study Design

 

Efficacy

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)22.

Secondary endpoints: Probability of response (KM estimates) or primary failure at 8 weeks# by subgroup (n=434)22.

PROSIT-BIO: Efficacy Results

 

Safety22

The primary endpoint was the the evaluation of safety in terms of rate of SAEs during the first year since the introduction of Inflectra®/CT-P13* (infliximab) for the overall population.

PROSIT-BIO: Safety Results

Breakdown of SAEs experienced by the overall population22.

PROSIT-BIO: Safety Results

Adapted from Fliorino G. et al. 2017.

*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response was studied among responders at Week 8 using time-to-event methods for censored observations (i.e., patients withdrawn from the study because of AEs, and patients who had not lost response on the final data collection date, were considered “censored”).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; KM, Kaplan-Meier; SAE, Serious adverse event; AE, Adverse event.

 

 

PP-IFA-GBR-0295. December 2018