Edward Barnes, MD on the VIVID Trials of Mirikizumab in Bio-Exposed Patients With Crohn's Disease

Dr Barnes reviewed his presentation of results from the VIVID 1 to VIVID 2 trials of mirkizumab in patients with Crohn's disease with exposure to anti-TNF therapy, which found that over 75% of those in endoscopic response at week 52 maintained multiple clinical endpoints, including clinical remission and endoscopic response.

Edward Barnes, MD, is an associate professor of Medicine, codirector of the UNC Multidisciplinary IBD Center, and director of the Gastroenterology Fellowship Program at the University of North Carolina at Chapel Hill.

Crohn’s disease — mirikizumab (VIVID-1/VIVID-2) in anti-TNF–exposed patients (DDW presentation, US)

• In Crohn’s disease, mirikizumab (VIVID-1 trial; treat-through to week 52) in patients with prior anti-TNF exposure achieved a significantly faster clinical response vs placebo by week 12, addressing a common real-world scenario where patients have already received advanced therapy.
• Over 52 weeks (VIVID-1), continued mirikizumab treatment led to greater separation vs placebo across outcomes, including clinical remission, steroid-free clinical remission, endoscopic endpoints, and composite clinical/endoscopic measures, demonstrating sustained benefit in this pretreated population.
• In the VIVID-2 long-term extension, among endoscopic responders at week 52, >75% maintained clinical endpoints (including clinical remission and combined clinical + endoscopic response), indicating durable efficacy even in patients with prior anti-TNF nonresponse or loss of response, supporting its role in therapy sequencing discussions in clinical practice.

Hi, I'm Ed Barnes from the University of North Carolina at Chapel Hill. And at DDW, I had the pleasure of presenting an evaluation from the VIVID-1 and VIVID-2 population where we specifically evaluated the utility of mirikizumab in patients with Crohn's disease who had already been exposed to one anti-TNF therapy. I think this was a really important analysis and a really important presentation because this is a very common clinical scenario that we see in our population of patients with Crohn's disease. Obviously, we'd love to know how well a therapy works in an advanced therapy-naive population. And in Crohn's disease, we want to treat patients as quickly as possible, but more often than not, patients are coming to our clinic and they've already been on one advanced therapy. And so it's really nice to know how well these therapies perform in patients that have already been exposed to therapies, particularly anti- TNF therapies.

And in this particular analysis, what we found is that compared to placebo, those patients were treated with mirikizumab in the VIVID-1 population achieved clinical response much more rapidly and in a significantly different way by week 12 compared to those patients who were receiving placebo. And then because mirikizumab's VIVID-1 population was a treat-through design, those patients who received mirikizumab continued to receive mirikizumab all the way through week 52. And consequently, those patients receiving placebo were on placebo during that period of time. And so during the longer period of time, we started to see a significant delta in multiple different evaluations, including clinical remission, steroid-free clinical remission, and multiple endoscopic endpoints, as well as composite endpoints using both clinical markers and endoscopic markers.

Now, one of the other interesting things that we were able to do is then combine those first-year data points with the long-term extension data from VIVID-2. And if you look at endoscopic responders, those patients who are in endoscopic response at week 52 that then went into that long-term extension and VIVID 1 to VIVID 2, we then saw that patients had durable response. Over 75% of patients maintaining multiple clinical endpoints, including clinical remission and this combination effects of clinical remission and then endoscopic response, really giving us a signal that even in patients who had already been on an anti-TNF therapy, if you achieved what we would consider really important endpoints by year 1, like clinical remission and endoscopic response, there was a durable clinical effect that we could really latch onto and we can talk to patients about even if they had already not had a response to anti-TNF therapy or they had lost response to anti-TNF therapy. Again, this I think is an important set of results when we think about our clinical practice and it's something that we should be reassured in talking to patients who are facing this scenario.

And as we've seen a vast array of new mechanisms that have been approved for the treatment of Crohn's disease, I think we start to think about how we might sequence our therapies as well. And so this becomes a very important talking point, again, when we transition these data from clinical trials back to our clinical practice. So I was really excited to have the opportunity to present these at DDW, and I hope this is helpful for your clinical practice as well.