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.