Table 2.
Secondary bacterial and fungal infections.
| ARM A (treatment group) n = 121 |
ARM B (SOC group) n = 55 |
P-value | |
|---|---|---|---|
| Bacterial infections | |||
| Pneumonia, N (%) | 6 (5.0%) | 1 (1.8%) | 0.323 |
| Blood stream infections, N (%) | 5 (4.1%) | 4 (7.3%) | 0.381 |
| Urinary tract infection, N (%) | 4 (3.3%) | 1 (1.8%) | 0.582 |
| SSTIS, N (%) | 1 (0.8%) | 0 | 0.499 |
| MDR infection, N (%) | 4 (28.6%) | 3 (75.0%) | 0.093 |
| Fungal infections | |||
| Candidemia, N (%) | 1 (0.8%) | 1 (1.8%) | 0.565 |
| >1 infection, N (%) | 3 (2.5%) | 3 (5.4%) | 0.313 |
| Presence of at least 1 secondary infection according to sarilumab dosesa | |||
| One dose, N (%) | 3/63 (4.8%) | – | |
| Two doses, N (%) | 11/58 (19.0%) | – |
MDR, multi drug resistant pathogens; n, number of participants; SSTIs, skin and soft tissue infections.
a
Number of infections occurred in one sarilumab dose group vs two sarilumab doses group, p = 0.015.