Table 2.
Incidence, duration, and resolution of MECs, BCVA change, and corneal symptoms in patients receiving belamaf (2.5 mg/kg) in DREAMM-2
| Eye examination findings per KVA scale | CTCAE scale | ||||
|---|---|---|---|---|---|
| MECs (n = 95) |
BCVA change (n = 95) | MECs + BCVA change (n = 95) | Blurred vision (n = 95) | Subjective dry eye (n = 95) |
|
| Any grade, n (%)a | 68 (72) | 51 (54) | 68 (72) | 24 (25) | 14 (15) |
| Maximum grade | |||||
| Grade 1 | 8 (8) | 7 (7) | 7 (7) | 11 (12) | 9 (9) |
| Grade 2 | 16 (17) | 15 (16) | 14 (15) | 9 (9) | 4 (4) |
| Grade 3 | 43 (45) | 28 (29) | 45 (47) | 4 (4) | 1 (1) |
| Grade 4 | 1 (1) | 1 (1) | 2 (2) | 0 | 0 |
| Median time to onset of first occurrence (range), days | 37.0 (19–143)b | 64.0 (20–213) | 36.0 (19–143) | 51.5 (6–339) | 42.0 (12–151) |
| Median duration of first event (range), days | 86.5 (8–358)b | 33.0 (8–127)b | 96.0 (8–358)b | 42.5 (6–441) | 39.0 (12–316) |
| First event outcomes,c n/N (%) | |||||
| Recovered | 46/60 (77)b | 34/44 (77)b | 45/61 (74)b | 16/24 (67) | 12/14 (86) |
| Not recovered | 14/60 (23)b | 10/44 (23)b | 16/61 (26)b | 8/24 (33) | 2/14 (14) |
| Event outcomes as of last follow-up,c n/N (%) | |||||
| Recovered | 29/60 (48)b | 26/44 (59)b | 30/61 (49)b | 15/24 (63) | 11/14 (79) |
| Not recovered | 31/60 (52)b | 18/44 (41)b | 31/61 (51)b | 9/24 (38) | 3/14 (21) |
| Dose delays due to event, n (%) | – | – | 45 (47)d | 7 (7)e | 3 (3) |
| Dose reductions due to event, n (%) | – | – | 24 (25)d | 2 (2)e | 0 |
Safety population (n = 95) defined as all patients who received ≥ 1 dose of belamaf
BCVA best-corrected visual acuity, CTCAE v4.03 Common Terminology Criteria for Adverse Events version 4.03, KVA keratopathy and visual acuity, MECs microcyst-like epithelial changes
aMEC and BCVA change grade based on KVA scale (Table 1) with MEC + BCVA grade based on the highest grade for either MECs or BCVA change per KVA scale. Blurred vision and dry eye graded based on CTCAE v4.03
bData for ≥ grade 2 events per KVA scale
cRecovery of MECs was defined as an event that was deemed clinically stable by the eye care professional. Clinical stability was defined as any grade 1 exam finding (per KVA scale) or no exam finding, and either a one-line decline in vision or no change in vision when compared with baseline
dDose delays and reductions were based on the grade for MECs + BCVA change
eIncluded preferred terms vision blurred, visual acuity reduced, visual impairment, diplopia