Table 3 Summary of AEs reported for clazakizumab at 25 mg - phase 2 trials in arthritis
Disease entity | Psoriatic arthritis | Rheumatoid arthritis | ||
|---|---|---|---|---|
Mease et al., 2016 [25] | Weinblatt et al., 2015 [20] | |||
Treatment | Placebo ± MTX | Clazakizumab ± MTX | Placebo + MTX | Clazakizumab + MTX |
Patients (n) | 41 | 41 | 61 | 59 |
Deaths (%) | 0 | 0 | 0 | 0 |
Gastrointestinal perforation (%) | 0 | 0 | 0 | 0 |
Malignancies (%) | 0 | 0 | 0 | 0 |
SAEs (%) | 4.9 | 4.9 | 3.3 | 8.5 |
Discontinuation (SAEs) (%) | 4.9 | 0 | 0 | 0 |
AEs (%) | 65.9 | 73.2 | 60.7 | 84.7 |
Discontinuation (AEs) (%) | 7.3 | 2.4 | 0 | 0 |
Infections (%) | 48.8 | 36.6 | Total infection rate not reported | |
Liver parameters (%) | ||||
ALT > 1–3 × ULN | 24.2 | 52.6 | 21.6 | 46 |
ALT > 3–5 × ULN | 0 | 5.3 | 2 | 3.7 |
ALT > 5–8 × ULN | 2.0 | 0 | 0 | 3.7 |
AST > 1–3 × ULN | 13.5 | 50 | 14.8 | 40 |
AST > 3–5 × ULN | 0 | 0 | 0 | 3.6 |
AST > 5–8 × ULN | 0 | 2.6 | 0 | 0 |
Total bilirubin (%) | ||||
> 1.0–1.5 × ULN | 0 | 10.8 | 0 | 8.8 |
> 1.5–2.0 × ULN | 0 | 5.4 | 0 | 1.8 |
> 2.0–3.0 × ULN | 0 | 2.7 | 0 | 0 |
Cases of Hy’s law | 0 | 0 | 0 | 0 |
LDL cholesterin | No details (lipids elevated) | Increase from < 130 to ≥ 130 mg/dL | ||
28.3 | 61.9 | |||
Neutrophil counts | Mean decrease by about 2 G/L | |||
0.5–1.0 × 109/L (%) | no details | 0 | 1.8 | |
1.0–1.5 × 109/L (%) | no details | 3.8 | 14.3 | |
Anti-clazakizumab antibodies (%) | – | 4.9 | – | 5.1 |
Injection site reaction (%) | – | 9.8 | – | 13.6 |