This is one of the largest studies aiming to describe the impact and pattern of infections in a comprehensive population, including all kinds of next-generation, B-cell depleting, anti-CD19 and CD20 immunotherapies in a real-life cohort. Because there’s a lot of data and literature about CAR T-cell therapy or bispecific antibodies, but not as much for ADC or Naked Ab, such as tafasitamab that we used, that we kind of studied in this analysis...
This is one of the largest studies aiming to describe the impact and pattern of infections in a comprehensive population, including all kinds of next-generation, B-cell depleting, anti-CD19 and CD20 immunotherapies in a real-life cohort. Because there’s a lot of data and literature about CAR T-cell therapy or bispecific antibodies, but not as much for ADC or Naked Ab, such as tafasitamab that we used, that we kind of studied in this analysis. This analysis, the main focus, the main focus is infections, infectious events.
In our analysis, we had 158 patients for a total amount of 195 immunotherapy lines. And based on these lines of immunotherapy, patients developed 162 infectious events. Not every patient, but some of the patients had from one to six infection events in a two year period of time. So in this period, we saw that mainly infectious events were developed in the first 100 days, like 76% of infection events were in the first 100 days. 59% were in the first 30 days. So for us, this is significant because for those kinds of immunotherapies, we can see that in the first period, in the very early time from the start of immunotherapy, we have the main risk of infection. We don’t have to forget that mainly also for CAR T-cell therapy, we have a risk of infection that can last also to more than 100 days. So the prophylaxis strategies have to be really focused on the patient and have to be continued during this amount of time. We also focused and concentrated on the cause of death on this cohort of patients, as is shown in literature, also in our study or in our analysis, lymphoma progression is the main cause of death for our patients. But infectious events were the first non-relapse mortality, non-relapse correlated mortality.
And for the impact that has on, I think, on… the clinical impact that has this study is that we have to improve on, not only improve, but like focus on the prophylaxis, I guess, because this is a multicenter study. So we had heterogeneous strategies of prophylaxis, heterogeneous strategies of treatment. But we saw that infection events were mild to moderate, so even though we had 162 infectious events, they were still manageable. Only six patients had grade five, so fatal, infectious events. The others were kind of grade from one to four and were still manageable in the clinical setting or not, also as outpatients. The prophylaxis were mainly on antiviral – 97% of immunotherapy lines received antiviral prophylaxis – 99% anti-pneumocystis prophylaxis – whilst for antifungal or antibacterial this was the choice of the prophylaxis on those kinds of infections, where more like it was center-guided, like every center had their own disposition, their strategies of prophylaxis, also based on the kind of patient that they had, so the characteristics of the patient too. I think this is our first goal.
We see that by the results of our studies, of our analysis, we couldn’t find the main principal risk factor for infection because of our limits of the study because it’s a retrospective study because it is a multi-center study that is a strength of our study but also a limit, because as I was saying we have a heterogeneous population, heterogeneous strategies of therapy. So we didn’t find one risk factor that was linked to the development of infectious events. We found that a correlation, if we want to say like this, between the administration of Ig immunoglobulin IV and the infectious events. This correlation is reversed, like the patients that developed an infection received more Ig immunoglobulin, intravenous immunoglobulin, because they were more fragile as patients.
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