I dismissed another a similar study the other week posted here which was more of a single site study on the basis that it used blood samples taken at the time of C-19 diagnosis. That was too early to detect most cytokine storms for C-19.However, the Lancet meta analysis is quite comprehensive and has used many studies and has recognised that issue and has tried to overcome it by using peak IL-6 serum values from the study sites.
The significantly higher cytokine storm markers in non C-19 ARDS, Sepsis and other cytokine storm conditions may indicate the lack of responsiveness for Rem-L in C19 ARDS and the reason for Novartis' main interest in none C-19 ARDS.
Remembering, C19 is a new disease and large datasets have taken a while to be produced and published on various aspects of it. Certainly, I'd be interested in comparing its cytokine storm markers to aGVHD where we know it is effective.
The hypothesis of the study was around Rem-L's MOA on cytokine storms. We also have to be mindful that MSB is blinded to the secondary endpoints which measure these markers (IL-6, IL-8 and TNF-alpha) but I just checked the inclusion criteria for the Rem-L study and only CRP was used. CRP is a more general inflammatory marker. VERY SURPRISING!
Is that a Eureka moment? How many of these patients even had cytokine storms? The Lancet paper is very informative on that.
Well, this opens up a lot lot of further analysis and implications which I don't have time to do now. But for me, it may offer a good explanation for the lack of knock out impact of Rem-L for C19 ARDS and also makes me quite hopeful still for the general ARDS program with Novartis which the Lancet paper shows values in the multiples of those cytokine storm markers as compared to C19 ARDS.
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