Table 1.
ARIA E summary table
| Patient ID | Original treatment assignment in EXP 1/2 | Baseline severity (Visit 1 MMSE) | Age at consent into feeder study (y) | APOE genotype | Relative onset (days)∗ | ARIA-E Sulcal and/or Parenchymal | Maximum ARIA-E severity | ARIA-H at baseline | ARIA-H at time of ARIA-E | MRI Outcome/Last observation |
|---|---|---|---|---|---|---|---|---|---|---|
| EXPEDITION | ||||||||||
| A | PBO | Mild | 79 | ε2/ε4 | 562 | Sulcal | Moderate | 1 | 6 to 10† | Complete resolution, 75 days |
| B | PBO | Mild | 80 | ε3/ε4 | 86 | Sulcal | Mild | 0 | 0 | Complete resolution, 36 days |
| C | SLZ | Mild | 81 | N/A | 365 | Parenchymal | Moderate | 6 to 10 | >10 | Partial resolution, 149 days (ED, ARIA-E) |
| D | SLZ | Mild | 73 | ε3/ε4 | 366 | Sulcal | Mild | 0 | 2 to 5† | Complete resolution, 189 days |
| E | SLZ | Mild | 80 | ε3/ε3 | 428 | Parenchymal | Mild | 6 to 10 | >10 | Complete resolution, 78 days |
| F | SLZ | Mild | 67 | ε4/ε4 | 561 | Sulcal | Severe | 1 | 2 to 5† | Partial resolution, 300 days (increased ARIA-H to >10 at discontinuation) |
| EXPEDITION 2 | ||||||||||
| G | PBO | Moderate | 69 | ε4/ε4 | 361 | Sulcal | Moderate | 2 to 5 | >10† | Partial resolution, 22 days (ED, ARIA-H) |
| H | PBO | Mild | 79 | ε2/ε3 | 566 | Parenchymal | Mild | 2 to 5 | >10 | Complete resolution, 661 days‡ |
| I | PBO | Mild | 70 | ε4/ε4 | 73 | Sulcal and Parenchymal | Mild | >10 | >10 | Partial resolution, 316 days (ED, ARIA-E) |
| J | SLZ | Mild | 93 | ε2/ε3 | 370 | Parenchymal | Severe | 0 | N/A | No change ARIA-E, 70 days (ED, ARIA-E; Increased ARIA-H to >10 at discontinuation) |
| K | SLZ | Mild | 72 | N/A | 22 | Sulcal | Moderate | 1 | 2 to 5† | Complete resolution, 227 days (ED, ARIA-H increased to 6–10) |
| L | SLZ | Mild | 69 | N/A | 83 | Sulcal | Mild | 2 to 5 | 2 to 5† | Complete resolution, 73 days |
| M | SLZ | Mild | 75 | ε3/ε3 | 197 | Parenchymal | Mild | >10 | >10 (increased) | Complete resolution, 54 days (ED) |
| N | SLZ | Mild | 74 | ε4/ε4 | 525 | Parenchymal | Moderate | 0 | 1† | Partial resolution, 51 days |
| O | SLZ | Moderate | 66 | ε3/ε4 | 361 | Parenchymal | Severe | 0 | 6 to 10† | Increased ARIA-E, 127 days (ED, ARIA-E) |
| P | SLZ | Moderate§ | 85 | ε3/ε3 | 79 | Parenchymal | Mild | 2 to 5 | N/A | Increased ARIA-E and ARIA-H to >10, 477 days |
| EXPEDITION-EXT‖ (All patients received open-label SLZ) | ||||||||||
| B | PBO | Mild | 80 | ε3/ε4 | 913 | Sulcal | Moderate | 0 | 0 | Complete resolution, 50 days |
| Q | PBO | Mild | 84 | ε3/ε4 | 915 | Parenchymal | Mild | 0 | >10 | No change, 33 days |
| R | PBO | Mild | 70 | ε4/ε4 | 730 | Sulcal | Mild | 0 | 2 to 5† | Complete resolution, 29 days |
| S | PBO | Mild | 72 | ε4/ε4 | 1295 | Parenchymal | Mild | 6 to 10 | >10 | Increased ARIA-E, 36 days |
| T | SLZ | Mild | 84 | ε3/ε3 | 1292 | Parenchymal | Moderate | 0 | 0 | No change, 32 days |
| U | SLZ | Moderate | 78 | ε2/ε3 | 1285 | Parenchymal | Mild | 0 | >10 | No change, 22 days (ED, ARIA-H) |
| V | SLZ | Mild | 79 | ε3/ε3 | 756 | Parenchymal | Mild | 2 to 5 | >10† | Increased ARIA-E, 243 days (ED, ARIA-E) |
Abbreviations: ED, early discontinuation; MMSE, Mini-Mental State Examination; N/A, not available; PBO, placebo; SLZ, solanezumab.
Relative onset (days) is calculated from date of first infusion in EXPEDITION or EXPEDITION 2.
Colocalization of new ARIA-H and ARIA-E.
Patient H developed ARIA-E during PBO treatment in EXPEDITION 2 then initiated treatment with SLZ in EXPEDITION-EXT and ARIA-E resolved during SLZ treatment during EXPEDITION-EXT.
Patient P had an MMSE score of 13 at visit 1, which was outside the inclusion and/or exclusion criteria for the study. At visit 2, Patient P had an MMSE score of 17 so is considered of moderate disease severity for this analysis.
Treatment during double-blind trial (all received SLZ in open-label trial). Relative onset of ARIA-E for patients treated with PBO in EXPEDITION and EXPEDITION 2 includes approximately 560 days of observation in those studies.