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. 2025 Jan 31;12(3):100068. doi: 10.1016/j.tjpad.2025.100068

Table 3.

Rates of ARIA and Mean CDR-SB Change According to APOE Genotype.

Lecanemab
Placebo
APOE ε4 status
APOE ε4 status
None
N = 278
Heterozygote
N = 479
Homozygote
N = 141
None
N = 286
Heterozygote
N = 478
Homozygote
N = 133
ARIA-E 5.4 % 10.9 % 32.6 % 0.3 % 1.9 % 3.8 %
Symptomatic ARIA-E 1.4 % 1.7 % 9.2 % 0 % 0 % 0 %
ARIA-H 11.9 % 14.0 % 39.0 % 4.2 % 8.6 % 21.1 %
CDR-SB −0.76
(−1.16, −0.35)
−0.51
(−0.79, −0.23)
+0.28
(−0.35, +0.88)
Ref Ref Ref

Donanemab
Placebo
APOE ε4 status
APOE ε4 status
None
N = 255
Heterozygote
N = 595
Homozygote
N = 143
None
N = 250
Heterozygote
N = 474
Homozygote
N = 146
ARIA-E 15.7 % 22.8 % 40.6 % 0.8 % 1.9 % 3.4 %
Serious ARIA-E 0.4 % 1.8 % 2.8 % 0 % 0 % 0 %
ARIA-H 18.8 % 32.4 % 50.3 % 11.2 % 12.0 % 20.5 %
Serious ARIA-H 0.4 % 0.2 % 1.4 % 0 % 0 % 0 %
CDR-SB −0.76
(−1.21, −0.31)
−0.73
(−1.06, −0.40)
−0.41
(−1.00, 0.19)
Ref Ref Ref

ARIA risk and clinical efficacy according to APOE genotype in the CLARITY-AD (lecanemab) and TRAILBLAZER-ALZ 2 (donanemab) trials. Values are percent (for ARIA) or, for CDR-SB, the adjusted mean difference from placebo (Ref). In TRAILBLAZER-ALZ 2, only the subset of symptomatic ARIA that was considered “serious” (i.e., resulted in death, was life-threatening, required hospitalization, or caused persistent disability) was reported by APOE status. For ease of comparison, change in CDR-SB is shown for both trials; the interaction between APOE status and iADRS (the primary outcome in TRAILBLAZER-ALZ 2) was similar. For TRAILBLAZER-ALZ 2, results are shown for the combined tau group.