Table 4.
Adverse events of subcutaneous tocilizumab in rheumatoid arthritis patients
| Patients with ≥1 AE (%, rate) |
Patients with ≥1 SAE (%, rate) |
Infection (%) |
SI (%, rate) |
ISR (%, rate) |
SIR (%, rate)** |
Neutropenia Grade 2% Grade 3% Grade 4% |
ALT increase Grade 1–2%, Grade 3–4% |
T Chol increase (%)# |
Patients with anti-TCZ (%) |
Withdrawal due to AE (%) |
|
|---|---|---|---|---|---|---|---|---|---|---|---|
| BREVACTA at 48 w14 | NA, 374 | NA, 13 | 30* | 3.4, 3.8 | 22, 24 | 0.7, 0.8 | NA NA NA |
NA NA |
NA | 3.0 | 6.3 |
| SUMMACTA at 24 w15 | 76, 603 | 4.8, 12 | 36 | 1.4, 3.1 | 10, 58 | 0.4, 0.7 | 13 3.0 0.2 |
54 1.0 |
15 | 0.8 | 4.8 |
| MUSASHI at 24 w16 | 89, NA | 7.5, NA | 42 | 1.2, NA | 12, NA | 3.5, NA | 11 3.0 0.0 |
24 0.6 |
24 | 3.5 | 1.7 |
| 8 mg/kg q4w in SUMMACTA and MUSASHI studies15,16 | 77–91, 588 | 5.2–5.8, 15 | 39–45 | 1.4–2.9, 3.5 | 2.4–5.2, 33 | 0.2–6.9, 0.3 | 9.7–13 3.2–2.9 0–0 |
48–24 1.1–1.2 |
8.3–27 | 0.8–0.0 | 6.7–5.2 |
Notes: Rate determined per 100 patient-years
at 24 weeks
from total cholesterol <200 mg/dL (5.2 mmol/L) at baseline to ≥240 mg/dL (6.2 mmol/L)
SIR from SAE in the SUMMACTA and BREVACTA studies, compared with SIR from AE in the MUSASHI study
from total cholesterol <200 mg/dL (5.2 mmol/L) at baseline to ≥240 mg/dL (6.2 mmol/L).
Abbreviations: AE, adverse events; ALT, alanine aminotransferase; anti-TCZ, anti-tocilizumab; I, infection; ISR, injection site reaction; q4w, every 4 weeks; NA, not available; SAE, severe adverse events; SI, severe infection; SIR, systemic immune reaction (AE within 24 hours of injection, not localized at the site of injection); T Chol, total cholesterol; w, weeks.