IBD- IXE trials data

Hello, my name is Professor Dennis McGonagle. In this video, I am going to be discussing the association between immune-mediated diseases including psoriatic arthritis, psoriasis, and ankylosing spondylitis, and how these sister diseases are linked to inflammatory bowel disease. First, it’s important to understand the heightened risk of IBD in such patients generally. Data pooled from epidemiological studies across several countries suggests that the risk is higher for patients with psoriasis, with psoriatic arthritis, and ankylosing spondylitis. So, IBD has been described as a co-morbidity of psoriasis, psoriatic arthritis, and is considered an extra-articular manifestation of ankylosing spondylitis. Looking at pooled data from ixekizumab psoriasis trials, there is data from over 5800 patients available. In this were 29 patients had new-onset IBD or experienced exacerbations of IBD symptoms. The incidence rate falls within the reported background rates for a psoriasis population. So moving on to the SPIRIT program of ixekizumab in psoriatic arthritis data is available in over 1,400 patients. 3 patients had new-onset IBD. And what about the incidence of IBD in patients with axial SpA under ixekizumab therapy? Data is available in 929 patients. We see an incidence rate of around 1%, which aligns with the typical rates for the ankylosing spondylitis population. A total of 13 patients had new-onset IBD or experienced an exacerbation of IBD symptoms. In pediatric patients, Crohn’s disease is more commonly diagnosed than ulcerative colitis. However, a similar pattern is seen in the incidence rates to that of adult population. The numbers are small and there is only data available in 196 patients in total with 253 patient years of exposure. The data is currently less robust due to the smaller sample size, obviously, and clearly there’s a heightened sensitivity around pediatric disease. Thus far, there is an incidence rate of 1.6 reported in the pediatric population treated with ixekizumab. There is also data on over 7,000 patients treated with another IL-17A inhibitor, namely secukinumab. Schreiber and colleagues reported a very similar pattern of IBD incidence across psoriasis, psoriatic arthritis, and ankylosing spondylitis. There is now initial real-world evidence emerging, and it is recapitulating what has been found in the trials. So, data from this 2019 meta-analysis suggests that IBD patients receiving IL-17 blockade; it’s rare to see IBD in this population. So in summary, across the ixekizumab clinical development programs for adult psoriasis, psoriatic arthritis, and axial spondyloarthritis, we have seen the overall exposure-adjusted incidence rates of Crohn’s disease and colitis per 100 patient-years are comparable to the background ranges reported for the populations affected by these conditions. In pediatric patients, we will continue to gather new data and look for emerging trends. So, with that I would like to thank you for your time. Thank you.