Table 4.
Safety assessment of tapering tocilizumab compared to its standard regimen.
| Adverse event (AE) | Standard-dose group | Tapering group | P value |
|---|---|---|---|
| (n = 858) | (n = 578) | ||
| Any mild/moderate AE, n (%) | |||
| Neutropenia | 11 (1.3) | 8 (1.4) | 0.979 |
| LFT abnormality (n = 1412) |
125 (14.8) | 69 (12.2) | 0.297 |
| TB | 0 (0.0) | 0 (0.0) | NA |
| NTM | 1 (0.1) | 4 (0.7) | 0.110 |
| Bacterial infection | 20 (2.3) | 12 (2.1) | 0.808 |
| Herpes zoster | 11 (1.3) | 8 (1.4) | 0.883 |
| HBV reactivation | 1 (0.1) | 3 (0.5) | 0.093 |
| Nasopharyngitis | 26 (3.0) | 14 (2.4) | 0.988 |
| Interstitial lung disease | 10 (1.2) | 6 (1.0) | 0.195 |
| Hypercholesterolemia (n = 1145) | 250 (37.9) | 159 (32.8) | 0.048 |
| Skin rash | 22 (2.6) | 11 (1.9) | 0.400 |
| Infusion reaction | 13 (1.5) | 5 (0.9) | 0.280 |
| Any serious AE, n (%) | |||
| Increased AST/ALT | 3 (0.4) | 1 (0.2) | 0.544 |
| Bacterial infection | 8 (0.9) | 5 (0.9) | 0.894 |
| Herpes zoster | 2 (0.2) | 0 (0.0) | NA |
| Skin rash | 0 (0.0) | 1 (0.2) | NA |
| Infusion reaction | 0 (0.0) | 1 (0.2) | NA |
ALT, alanine transaminase; AST, aspartate transaminase; HBV, hepatitis B virus; NA, non-applicable; NTM, non-tuberculosis mycobacterium; TB, tuberculosis.