ASH 2023 | Sutimlimab in cold agglutinin disease: a post-hoc analysis of safety data from CARDINAL & CADENZA

So what we were looking at in this post-hoc analysis is two of the recently reported upon Phase III trials in patients with cold agglutinin disease and sutimlimab, which is an inhibitor of the classical complement pathway. In CARDINAL, it was a trial where patients were entered on who had received two or more transfusions in the preceding six months, and in CADENZA, this was a placebo-controlled trial for patients who had cold agglutinin disease, but who had not received any blood transfusions in the preceding six months. And we wanted to look at sort of the long-term safety of interfering with the classical complement pathway or blocking classical complement pathway activation in these patients with cold agglutinin disease. 

So when we combined the data from these two studies and really looked at a safety analysis, what we evaluated were adverse events of special interest, which included thromboembolic events as well as infections with encapsulated organisms like Meningococcus, Streptococcus, and Haemophilus. We also looked at any treatment-emergent adverse events. And what we found was that, in treating these patients over a long period of time, we did not see the emergence of any unexpected or untoward adverse events. Overall, this therapy was very well tolerated, and most of the adverse events that were noted in both of these clinical trials were very consistent with an older population of patients who may have multiple comorbidities, such as we see in the real world with cold agglutinin disease.