In this video, Mark Lebwohl, MD, discusses findings from a study on noteworthy adverse effects associated with the IL-23 inhibitor, risankizumab. The study was presented at the 29th EADV Congress.
Dr Lebowhl is the Waldman Professor and Chairman of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, NY.
Dr. Mark Lebwohl: This poster's important because risankizumab does block IL‑23. The question would be, are we going to see any side effects, like malignancy, infection, or major adverse cardiovascular events?
The median treatment in this study was 2.9 years. There were 1,455 patients who had been on the drug for more than three years and 172 patients who had been on the drug for more than four years.
In general, the rates of adverse events, expressed as cases per 100 patient‑years, were not increased over time and were not increased compared to the general public. The rate of serious infection, 1.2 per 100 patient‑years, again, not increased over time and not increased compared to the general public. In their placebo group, they had a rate of 1.1 cases of serious infections per 100 patient‑years.
Malignancies, there were only 42 out of 3,072 patients for a rate of 0.5 per 100 patient‑years. That is actually lower than the rate in the general public. The placebo period was only 300 patients and only over 16 weeks, and that rate was zero.
The rate of non‑melanoma skin cancers was 0.7 per 100 patient‑years in the long‑term risankizumab arm. In the placebo arm, it was 1.1 per 100 patient‑years. Again, the risankizumab‑treated rate was not higher than the placebo rate.
In terms of major adverse cardiovascular events, the rate in the risankizumab group was 0.3 per 100 patient‑years, and in the placebo group, it was 1.1 per 100 patient‑years, so again, lower than the placebo group. That just hits home the message that this is a safe drug, even given over years.
There were no cases of active tuberculosis in patients who are IL‑12 and IL‑23‑deficient at birth. Micro‑bacterial infections are indeed a problem, not in these patients treated with risankizumab.
We do have other patient registries to compare the data too, and the data here is very comparable to the PSOLAR registry which studied several biologics. It was actually established to study ustekinumab, but it looked at patients on biologics and patients on other disease‑modifying, anti‑rheumatic drugs, like methotrexate.
Again, the rates here were not higher, and, in fact, were usually lower than the rates seen in those trials.
The conclusion was that the rates of adverse events seen in this study were consistent with previous studies of risankizumab, up to 52 weeks. It included a study of 3,072 patients with 7,927.2 patient‑years of exposure. Literally, every piece of evidence in this poster points to the safety of this drug.