In THRIVE and THRIVE-2, Lumvoa™ (veligrotug-vvze) demonstrated safety and tolerability profiles in active and chronic TED patients1
Adverse reactions occurring in ≥5% of patients with active or chronic TED1
| Adverse Reactions | Lumvoa N=200 n (%) | Placebo N=101 n (%) |
|---|---|---|
| Muscle spasms | 79 (40%) | 7 (7%) |
| Headache | 34 (17%) | 14 (14%) |
| Hearing impairment* | 29 (15%) | 6 (6%) |
| Hyperglycemia† | 25 (13%) | 5 (5%) |
| Fatigue‡ | 25 (13%) | 11 (11%) |
| Diarrhea | 22 (11%) | 7 (7%) |
| Ear discomfort§ | 19 (10%) | 3 (3%) |
| Infusion-related reaction | 18 (9%) | 2 (2%) |
| Nausea | 15 (8%) | 6 (6%) |
| Nasopharyngitis | 14 (7%) | 1 (1%) |
| Blood creatine phosphokinase increased | 12 (6%) | 1 (1%) |
| Dry skin | 12 (6%) | 2 (2%) |
| Hypertension | 11 (6%) | 5 (5%) |
94% of Lumvoa patients and 99% of placebo patients completed 5 infusions, reflecting the low discontinuation rate of Lumvoa.1
Adverse reactions were mostly mild and transient and generally resolved during or after treatment.2,3
Menstrual disorders were reported in approximately 29% (24/82) of menstruating women treated with Lumvoa compared to 6% (2/33) of patients treated with placebo in the clinical trials.1
*Hearing impairment includes tinnitus, hypoacusis, deafness, and autophony.
†Hyperglycemia includes blood glucose increased, glucose tolerance impaired, glycosylated hemoglobin increased, diabetes mellitus, glucose urine present, and impaired fasting glucose.
‡Fatigue includes asthenia.
§Ear discomfort includes ear feels clogged or blocked, ear plugging, sensation of ear pressure, and ear popping.
Hearing impairment adverse events2,3‖
| THRIVE | THRIVE-2 | |||
|---|---|---|---|---|
| Lumvoa (N=75) | Placebo (N=38) | Lumvoa (N=125) | Placebo (N=63) | |
| All hearing impairment AEs, n (%) | 12 (16.0%) | 4 (10.5%) | 17 (13.6%) | 2 (3.2%) |
| Tinnitus | 8 (10.7%) | 4 (10.5%) | 10 (8.0%) | 2 (3.2%) |
| Autophony | 1 (1.3%) | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) |
| Reduction in hearing | 3 (4.0%) | 0 (0.0%) | 8 (6.4%) | 1 (2.0%) |
| Hypoacusis | 2 (2.7%) | 0 (0.0%) | 6 (4.8%)¶ | 0 (0.0%) |
| Deafness neurosensory | 1 (1.3%) | 0 (0.0%) | 1 (0.8%) | 0 (0.0%) |
| Unilateral deafness | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (2.0%) |
| Leading to discontinuation | 0 (0.0%) | 0 (0.0%) | 1 (0.8%)¶ | 0 (0.0%) |
| Resolution | 9/12 (75%)(1 hypoacusis and 2 tinnitus unresolved) | 3/4 (75%)(1 tinnitus unresolved) | 10/17 (59%)(1 sensorineural deafness# and 5 tinnitus unresolved) | 0/2 (0%)(1 tinnitus and 1 unilateral deafness unresolved) |
‖Percentages are based on patients (not events). Individual patients may report multiple hearing‑impairment AEs; categories may overlap.2
¶Due to sensorineural deafness, preceded by otitis media and nasopharyngitis.3
#Patient was lost to follow up.3
AE=adverse event.