Table 3.
Incidence of adverse events receiving TCZ-SC and TCZ-IV
| BREVACTA study37
|
MUSASHI study36
|
SUMMACTA study35
|
|||
|---|---|---|---|---|---|
| TCZ-SC 162 mg q2w n=437 | TCZ-SC 162 mg q2w n=173 | TCZ-IV 8 mg/kg q4w n=173 | TCZ-SC 162 mg qw n=631 | TCZ-IV 8 mg/kg q4w n=631 | |
| Discontinuation rate due to AEs | 21 (4.8%) | 3 (1.7%) | 9 (5.2%) | 30 (4.8%) | 42 (6.7%) |
| Serious AEs | 25 (5.7%) | 13 (7.5%) | 10 (5.8%) | 34 (5.4%) | 43 (6.8%) |
| Serious infection | 12 (2.7%) | 2 (1.2%) | 5 (2.9%) | 9 (1.4%) | 9 (1.4%) |
| Shift in total cholesterol from baseline <200 mg/dL to >240 mg/dL | NA | 32 (18.5%) | 35 (20.2%) | 44 (7.0%) | 26 (4.1%) |
| Shift in ALT normal at baseline to value >3× ULN | NA | 5 (2.9%) | 9 (5.2%) | 30 (4.8%) | 32 (5.1%) |
| Shift in AST normal at baseline to value >3× ULN | NA | 2 (1.2%) | 6 (3.5%) | 6 (1.0%) | 8 (1.3%) |
| Shift in neutrophil normal at baseline to value <1,000/mm3 | NA | 5 (2.9%) | 5 (2.9%) | 18 (2.9%) | 20 (3.2%) |
| ISR | 57 (10.3%) | 21 (12.1%) | 9 (5.2%) (placebo) | 61 (10.1%) | 15 (2.4%) (placebo) |
Notes: Data are from a report by BREVACTA study,37 MUSASHI study.36 All values are expressed as number of the patients (%). Data adapted from Burmester GR, Rubbert-Roth A, Cantagrel A, et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis. 2014;73(1):69–74.35 Copyright © 2014, BMJ Publishing Group Ltd and the European League Against Rheumatism.
Abbreviations: TCZ, tocilizumab; SC, subcutaneous; IV, intravenous; AE, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal; ISR, injection site reaction; q2w, every 2 weeks; qw, every week; q4w, every 4 weeks; NA, not available.