Dr. Brian Bressler, MD, MPh, FRCPC, Gastroenterologist

Duration: 4 minutes, 22 seconds

The latest data that we have for CT-P13 actually relates to Crohn’s disease. So this was a study designed to look at the similarity of CT-P13 compared to Remicade in clinical endpoints for Crohn’s disease. So these were patients who had active Crohn’s disease and they were randomized to either Remicade or CT-P13, and the primary endpoint was after or at induction, week six, that there was no difference – or no substantial difference – with regards to clinical response in those two groups.

That was the primary endpoint, but there were many other aspects of the study that we are beginning to understand and digest and potentially use in our clinical practice. These patients were followed in that randomized fashion for 30 weeks and again, no signals at the end of that time frame that the clinical parameters differed with regards to efficacy or safety.

And then, at week 30, they were randomized again. So patients that were on CT-P13 either stayed, or were switched or transitioned to Remicade, and vice versa for those on Remicade. And they were then followed to the end of a year, and at the end of a year we had some even more critical objective measures to explore to understand if indeed these drugs, or these molecules, are behaving in a similar way.

And what I mean by that, there was an endoscopic assessment, and the signals from the endoscopic analysis suggested that indeed the performance of each molecule were similar. Other objective biomarkers like fecal calprotectin or CRP also has demonstrated to us similar signals.

Before we had the final results of CT-P13 we have been focused in understanding and interpreting cohort studies, for the most part, when it relates to inflammatory bowel disease. So there are many places throughout the world that are routinely starting patients on CT-P13 and as well, transitioning patients from Remicade to CT-P13.

The signals for the most part across the world is indeed their expectations with regards to efficacy and safety of either strategy would be appropriate. If we focus on the primary endpoint with regards to clinical response at induction, that’s what this study was designed to show.

I think it’s quite clear that this idea of extrapolation, of using CT-P13 instead of Remicade for an active Crohn’s disease patient is a reasonable option. When having the discussion to patients with regards to using a biosimilar compared to an innovator molecule, in many regards that’s a tricky discussion.

And the points that I would focus on is how science has enabled us to have the opportunities to use a molecule that could lead to the potential similar efficacy and similar safety of a molecule that we’ve been so comfortable with for many years in that particular patient.

I would reinforce to a patient, when discussing to patients, that indeed these molecules have been studied in ways that the health authorities in our country, so in Canada Health Canada, has deemed to be appropriate. And we’re following very carefully, and very closely, the guidance of Health Canada when making these decisions with regards to the potential value of using a biosimilar instead of the innovator molecule.

Where do we go from here? My strong suggestion for you is that I think that indeed the results of this particular study will have implications in your practice. So what you need to do – I would encourage you strongly – is to read the manuscript, digest that, understand the results that are being demonstrated and proven in this particular study.

I firmly believe that the results of this particular clinical trial reinforces the signals that we’re getting throughout the world when it comes to the expectations with regards to efficacy and safety of CT-P13 in using it for our patients with Crohn’s disease.

Presenter: Dr. Brian Bressler, Gastroenterologist, Vancouver, BC

Local Practitioners: Gastroenterologist