Table 3.
Event Table for Severe Hypoglycemia, Hypersensitivity Reactions, Injection Site Reactions, Treatment-Emergent Adverse Events, and Serious Adverse Events with Treatment-Emergent Anti-Insulin Antibodies in SORELLA 1 and SORELLA 2 – Anti-Insulin Antibody Populations
| SORELLA 1 (52 weeks) | SORELLA 2 (26 weeks) | |||||||
|---|---|---|---|---|---|---|---|---|
| Treatment-emergent AIA | Treatment-emergent AIA | |||||||
| Yesa | No | Yesa | No | |||||
| SAR-Lis (N = 56) | Ly-Lis (N = 61) | SAR-Lis (N = 192) | Ly-Lis (N = 191) | SAR-Lis (N = 46) | Ly-Lis (N = 36) | SAR-Lis (N = 199) | Ly-Lis (N = 211) | |
| Hypoglycemia, n (%) | ||||||||
| Severe hypoglycemia | 10 (17.9) | 6 (9.8) | 23 (12.0) | 28 (14.7) | 0 | 1 (2.8) | 6 (3.0) | 2 (0.9) |
| Hypersensitivity reactions and injection site reactions, n (%) | ||||||||
| Any hypersensitivity reactions | 1 (1.8) | 2 (3.3) | 14 (7.3) | 14 (7.3) | 1 (2.2) | 1 (2.8) | 8 (4.0) | 8 (3.8) |
| Any injection site reactions | 0 | 2 (3.3) | 3 (1.6) | 1 (0.5) | 1 (2.2) | 1 (2.8) | 0 | 3 (1.4) |
| TEAEs and SAEs, n (%) | ||||||||
| Any TEAE | 30 (53.6) | 32 (52.5) | 106 (55.2) | 109 (57.1) | 21 (45.7) | 14 (38.9) | 92 (46.2) | 92 (43.6) |
| Any SAE | 4 (7.1) | 6 (9.8) | 16 (8.3) | 13 (6.8) | 2 (4.3) | 4 (11.1) | 10 (5.0) | 21 (10.0) |
a
Participants with preexisting AIAs that were boosted to a significant higher titer (at least fourfold increase) compared to baseline, or participants without preexisting AIA (or missing baseline) and with at least one positive AIA sample.
TEAE, treatment-emergent adverse event; SAE, serious adverse event; SAR-Lis, SAR34243.