There is a lot to work through, though from what I have seen very very solid result. All the secondaries strongly confirmed the topline primary. Numbers were right where they were expected.
Safety for the hetero APOE4s were as promised surprisingly good. Interestingly on the macrohemorrhage slide they report 6 of 898 all Lecanemab patients (0.7%) or 2 of 83 (2.4%) on anti-coagulant and on Lecanemab with macrohemorrhage. In the footnotes it is noted that 1 of these patients (present in both of the groupings previously noted) was off Lecanemab treatment for >30 days. considering that Lecanemab has a half life of ~7 days. You have to wonder whether there would actually be a meaningful quantity of mab still in the patient's system ( >30 days would be ~ >4 half-lives (though it is possible that Lecanemab remodels the cerebral vascular system beyond its actual presence in the brain.
Only problem I can see is converting 59.1 Centiloids into SUVR. I really want to see where the amyloid removal will line up in CDR-sb vs. SUVR space. That is the whole basis for accelerated approval!
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Saw this in previous research, though I could hardly believe it. Above confirms that isolated ARIA-H microhemorrhage occurs at the same percentage in Lecanemab treated and placebo patients. Also surprising is that e4- and e4 heterozygotes that essentially the same percentage of ARIA-H (the e4 hetero Lecanemab subgroup % nearly equals the placebo %).
Last edited by J11 on Sat Dec 17, 2022 9:43 pm, edited 1 time in total.
Of note in this slide is the percent of patient on anticoagulants. These patients are most affected by side effects. I had not realized that this subgroup only represented 5% of treated patients.