Table 6.
Safety outcomes.
| N°(%) | ||
|---|---|---|
| Outcomes | Sarilumab + SC (n = 20) | SC (n = 10) |
| Any adverse event of special interest | ||
| Number of patients | 10 (50) | 4 (40) |
| Number of events, n | 11 | 4 |
| Neutropenia Grade IV | 0 | 0 |
| Increased liver enzymesa | 5 (25) | 3 (30) |
| Steroid-induced hyperglycemia | 4 (20) | 1 (10) |
| Invasive bacterial or fungal infection | 2 (10) | 0 |
| Serious adverse event | ||
| Number of patients | 4 (20) | 0 (0) |
| Number of events, nb | 5 | 0 |
| Secondary bacterial infectionc | 2 (10) | 0 |
| One organ (lung) failure | 1 (5) | 0 |
| Two organ (lung/kidney) failure | 2 (10) | 0 |
SC, Standard care.
a
Increase in liver enzymes indicates an increase in serum levels of alanine and aspartate aminotransferases more than three times the upper limit of normal.
b
One patient with respiratory and kidney failure under invasive mechanical ventilation also presented a respiratory bacterial infection by Achromobacter xylosoxidans.
c
Refers to the same infection episodes described as AEs of special interest.