Summary of adverse events of special interest
| Total exposure (PY) | 30 mg | Total | |
| 773.39 | 1419.34 | ||
| Serious infection (except tuberculosis) | No. (%) | 25 (8.6) | 48 (9.4) |
| IR | 3.88 | 3.80 | |
| 95% CI | (2.71 to 5.55) | (2.91 to 4.97) | |
| Tuberculosis | No. (%) | – | 1 (0.2) |
| IR | – | 0.07 | |
| 95% CI | – | (0.01 to 0.50) | |
| Interstitial lung disease | No. (%) | 14 (4.8) | 23 (4.5) |
| IR | 1.94 | 1.69 | |
| 95% CI | (1.17 to 3.22) | (1.13 to 2.52) | |
| Malignant tumours | No. (%) | 17 (5.9) | 23 (4.5) |
| IR | 2.33 | 1.76 | |
| 95% CI | (1.47 to 3.69) | (1.19 to 2.61) | |
| Major adverse cardiovascular event | No. (%) | 3 (1.0) | 4 (0.8) |
| IR | 0.39 | 0.28 | |
| 95% CI | (0.13 to 1.20) | (0.11 to 0.75) | |
| Venous thromboembolism | No. (%) | – | – |
| IR | – | – | |
| 95% CI | – | – | |
| Psoriasis | No. (%) | 5 (1.7) | 10 (1.9) |
| IR | 0.78 | 0.78 | |
| 95% CI | (0.35 to 1.73) | (0.43 to 1.40) | |
| Systemic lupus erythematosus or lupus-like syndrome | No. (%) | 1 (0.3) | 4 (0.8) |
| IR | 0.13 | 0.28 | |
| 95% CI | (0.02 to 0.92) | (0.11 to 0.75) | |
| Serious allergic reaction | No. (%) | – | – |
| IR | – | – | |
| 95% CI | – | – | |
| Serious blood disorders | No. (%) | 1 (0.3) | 2 (0.4) |
| IR | 0.13 | 0.14 | |
| 95% CI | (0.02 to 0.92) | (0.04 to 0.56) | |
| Demyelination | No. (%) | – | – |
| IR | – | – | |
| 95% CI | – | – | |
| Hepatitis B DNA assay positive | No. (%) | 5 (1.7) | 5 (1.0) |
| IR | 0.65 | 0.35 | |
| 95% CI | (0.27 to 1.55) | (0.15 to 0.85) | |
| Injection site reaction | No. (%) | 7 (2.4) | 13 (2.5) |
| IR | 9.70 | 5.99 | |
| 95% CI | (7.73 to 12.16) | (4.84 to 7.41) | |
| Abnormal liver function tests | No. (%) | 68 (23.4) | 117 (22.8) |
| IR | 16.94 | 15.64 | |
| 95% CI | (14.27 to 20.10) | (13.71 to 17.84) | |
Each event consists of the number of subjects (%), number of events per 100 PY and 95% CI. A blank in the table indicates no event in the analysis.
IR, incidence rate; PY, person-year.