Table 3.
Summary of ARIA Incidence in ENGAGE and EMERGE Studies, in the Placebo-Controlled Period
| ENGAGE (Study 301) | EMERGE (Study 302) | |||||
|---|---|---|---|---|---|---|
| Placebo N=533 | Low-Dose ADU N=544 | High-Dose ADU N=554 | Placebo N=544 | Low-Dose ADU N=537 | High-Dose ADU N=541 | |
| ARIA (either E or H) (%) | 9.8 | 30.7 | 40.3 | 10.3 | 32.8 | 41.2 |
| Asymptomatic | 94.2 | 83.2 | 70.9 | 94.6 | 78.4 | 80.3 |
| Symptomatic | 5.8 | 16.8 | 29.1 | 5.4 | 21.6 | 19.7 |
| ARIA-E (%) | 3.0 | 25.6 | 35.7 | 2.2 | 26.1 | 34.4 |
| ApoE ε4 carriers | 2.4 | 28.7 | 41.8 | 1.9 | 29.8 | 42.5 |
| ApoE ε4 non-carriers | 4.3 | 17.5 | 22.7 | 2.9 | 18.1 | 17.9 |
| ARIA-H, microhemorrhage (%) | 5.8 | 15.6 | 17.7 | 7.0 | 16.4 | 18.9 |
| ARIA-H, superficial siderosis, (%) | 1.9 | 8.8 | 15.5 | 2.6 | 9.3 | 13.5 |
| ARIA-H, macrohemorrhage (%) | 0.8 | 0 | 0.5 | 0 | 0.2 | 0.6 |
Note: Data from Biogen.35
Abbreviations: ApoE, Apolipoprotein E; ADU, Aducanumab; ARIA, Amyloid Related Imaging Abnormalities; ARIA-E, Amyloid Related Imaging Abnormalities due to Edema/Effusion; ARIA-H, Amyloid Related Imaging Abnormalities due to Microhemorrhage, Superficial Siderosis or Macrohemorrhage; N, Patients with at least one post-baseline magnetic resonance imaging.