TEAEs during the 24-week treatment phase
| Placebo (n=45) | 10 mg (n=45) | 50 mg (n=47) | 200 mg (n=46) | |
|---|---|---|---|---|
| Deaths, n (%) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 3 (6.5) |
| SAEs (excluding infections), n (%)* | 5 (11.1) | 2 (4.4) | 1 (2.1) | 5 (10.9) |
| Serious infections, n (%) | 2 (4.4) | 1 (2.2) | 2 (4.3) | 4 (8.7) |
| Sepsis | 1 (2.2) | 0 (0.0) | 1 (2.1) | 1 (2.2) |
| Bronchitis | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Tuberculosis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) |
| Bronchopneumonia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) |
| Cellulitis | 0 (0.0) | 1 (2.2) | 1 (2.1) | 1 (2.2) |
| Clostridium difficile colitis | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Sinusitis | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any AEs (excluding infections and ISRs), n (%) | 34 (75.6) | 34 (75.6) | 32 (68.1) | 31 (67.4) |
| Common AEs (≥5% in any treatment group, excluding infections and ISR), n (%) | ||||
| Headache | 2 (4.4) | 4 (8.9) | 5 (10.6) | 5 (10.9) |
| Nausea | 5 (11.1) | 2 (4.4) | 3 (6.4) | 5 (10.9) |
| Diarrhoea | 5 (11.1) | 2 (4.4) | 2 (4.3) | 3 (6.5) |
| SLE | 3 (6.7) | 3 (6.7) | 2 (4.3) | 1 (2.2) |
| Arthralgia | 3 (6.7) | 1 (2.2) | 2 (4.3) | 2 (4.3) |
| Dizziness | 2 (4.4) | 1 (2.2) | 3 (6.4) | 2 (4.3) |
| Cough | 2 (4.4) | 4 (8.9) | 0 (0.0) | 1 (2.2) |
| Hypercholesterolaemia | 1 (2.2) | 1 (2.2) | 4 (8.5) | 1 (2.2) |
| Hypertriglyceridaemia | 1 (2.2) | 1 (2.2) | 2 (4.3) | 3 (6.5) |
| Insomnia | 2 (4.4) | 1 (2.2) | 1 (2.1) | 3 (6.5) |
| Rash | 1 (2.2) | 0 (0.0) | 2 (4.3) | 4 (8.7) |
| Hyperglycaemia | 0 (0.0) | 3 (6.7) | 0 (0.0) | 2 (4.3) |
| Injection-site pain | 1 (2.2) | 0 (0.0) | 3 (6.4) | 2 (4.3) |
| Pain in extremity | 2 (4.4) | 0 (0.0) | 1 (2.1) | 3 (6.5) |
| Contusion | 0 (0.0) | 3 (6.7) | 1 (2.1) | 5 (2.7) |
| Fever | 4 (8.9) | 0 (0.0) | 1 (2.1) | 0 (0.0) |
| Vomiting | 3 (6.7) | 1 (2.2) | 0 (0.0) | 1 (2.2) |
| Back pain | 0 (0.0) | 1 (2.2) | 0 (0.0) | 3 (6.5) |
| Upper abdominal pain | 0 (0.0) | 3 (6.7) | 0 (0.0) | 1 (2.2) |
| Any infectious AE | 20 (44.4) | 19 (42.2) | 23 (48.9) | 19 (41.3) |
| Common infectious AEs (≥5% in any treatment group), n (%) | ||||
| Upper respiratory infection | 5 (11.1) | 5 (11.1) | 5 (10.6) | 10 (21.7) |
| Cystitis (urinary tract infection) | 3 (6.7) | 3 (6.7) | 3 (6.4) | 1 (2.2) |
| Pharyngitis/laryngitis | 4 (8.9) | 2 (4.4) | 4 (8.5) | 0 (0.0) |
| Sinusitis | 1 (2.2) | 2 (4.4) | 3 (6.4) | 2 (4.3) |
| Vaginitis | 0 (0.0) | 4 (8.9) | 0 (0.0) | 3 (6.5) |
| Discontinuations due to AEs, n (%) | 3 (6.7) | 3 (6.7) | 2 (4.3) | 2 (4.3) |
*SAEs that affected more than one patient: PE (placebo, n=1; 10 mg, n=1; 200 mg, n=2), SLE (placebo, n=2).
AEs, adverse events; ISR, injection-site reaction; PE, pulmonary embolism; SAEs, serious AEs; SLE, systemic lupus erythematosus; TEAEs, treatment-emergent AEs.