Evaluating the Safety of Ixekizumab in Psoriasis and Arthritis Patients

ReachMD Announcer:
You’re listening to Clinician’s Roundtable on ReachMD. On this episode, we’ll hear from Dr. Atul Deodhar, who’s a Professor of Medicine and the Medical Director of Rheumatology Clinics at Oregon Health & Science University. He’ll be discussing the risk of adverse events associated with the treatment option ixekizumab in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis, based on data from a recent study. Here’s Dr. Deodhar now.

Dr. Deodhar:
Depression and suicidality are issues for patients with psoriasis and psoriatic arthritis, and there is a history of this issue with some treatments, which are IL-17 inhibitors. There was a drug called brodalumab, which was an IL-17 receptor inhibitor, and that drug ultimately got pulled out of the market because there were increased risk of depression and suicidality. Because of that, the rheumatology community as well as the patient community and even FDA got very sensitized to the worry of depression and suicidality in drugs that block interleukin 17. This drug, ixekizumab, is an IL-17A inhibitor. The previous drug, which actually had the serious problem, was blocking IL-17 receptor, so it blocked IL-17A, B, C, D, E and F. So for this particular study where we looked at the 25 studies done in psoriasis, psoriatic arthritis, and axial spondyloarthritis, we were very interested in this particular side effect, and what we found was for the risk of depression and suicidality or self injury, the incidence rate per 100 patient years was around 1; it was 0.9 in axial spondyloarthritis to 1.6 in psoriatic arthritis. In psoriasis, it was 1.2. So this wasn’t anywhere close to the other study that we were concerned about.

The other question patients have is “What about heart attacks?” and “What about cancers?” Those are the worries patients have. And in this study, when we looked at the risk of MACE, which is major adverse cardiovascular event, which includes heart attacks and strokes and these things, that risk was very low. It was less than 0.5 per hundred patient years. And for cancer, it was also pretty low. It was less than one per hundred patient years. It was 0.4 to 0.8. These numbers are important because when I’m counseling the patient in the clinic, I can use these numbers and say that if I treat 100 patients like you for a year, less than one of them is going to have cancer. If I had 200 patients like you for a year, about one would have heart disease. And again, these are not related to the drug, but this is what we found out in this pooled safety study that we did.

The last one was iritis or uveitis, and this is especially an issue that patients with axial spondyloarthritis get. Forty percent of patients with ankylosing spondylitis, for example, will get iritis or uveitis in their lifetime, and there is a question on whether IL-17 inhibitors help or they don’t help. In this analysis that we did, we pooled all the axial spondyloarthritis studies and the total patient years was about 2,100 patient years. We found out that the incidence was close to three; 2.8 per hundred patient years. In psoriatic arthritis, there were absolutely no cases whatsoever, and there were only two cases in the entire nearly 7,000 patient database of psoriasis. So very, very rare in psoriasis, psoriatic arthritis, and about 2.8 per hundred patient years. So again, these are low numbers. It doesn’t tell us whether this drug treats this condition, but it certainly tells us that patients who are taking ixekizumab will not be having worsening of their uveitis looking at these data. 

ReachMD Announcer:
That was Dr. Atul Deodhar talking about the risk of adverse events associated with the treatment option ixekizumab in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. To access this and other episodes in our series, visit Clinician’s Roundtable on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening!