Common SAE in tocilizumab-treated RA patients
| No of events | |||
|---|---|---|---|
| (/100 patient-years) | |||
| Total | 490 | (27.3) | |
| Infections and infestations | 163 | (9.09) | |
| Pneumonia* | 47 | (2.62) | |
| Cellulitis | 19 | (1.06) | |
| Herpes zoster | 11 | (0.61) | |
| Atypical mycobacterial infection | 9 | (0.50) | |
| Arthritis bacterial and arthritis infective | 9 | (0.50) | |
| Diverticulitis | 6 | (0.33) | |
| Pneumocystis jiroveci pneumonia | 5 | (0.28) | |
| Sepsis and septic shock | 5 | (0.28) | |
| Gastroenteritis | 5 | (0.28) | |
| Tuberculosis† | 4 | (0.22) | |
| Bronchitis | 4 | (0.22) | |
| Pyelonephritis | 4 | (0.22) | |
| Malignancies | 15 | (0.84) | |
| Breast cancer | 2 | (0.11) | |
| Gastric cancer | 2 | (0.11) | |
| B-cell lymphoma | 1 | (0.06) | |
| Basal cell carcinoma | 1 | (0.06) | |
| Bile duct cancer | 1 | (0.06) | |
| Bladder neoplasm | 1 | (0.06) | |
| Lymphoma | 1 | (0.06) | |
| Meningioma | 1 | (0.06) | |
| Pleural mesothelioma | 1 | (0.06) | |
| Uterine cancer | 1 | (0.06) | |
| Large intestine carcinoma | 1 | (0.06) | |
| Cervix carcinoma | 1 | (0.06) | |
| Lung neoplasm | 1 | (0.06) | |
| Others | |||
| Cardiac function disorder | 25 | (1.39) | |
| ILD and organising pneumonia | 23 | (1.28) | |
| White blood cell count decreased | 15 | (0.84) | |
| Hepatobiliary disorder | 12 | (0.67) | |
| Neutrophil count decreased | 10 | (0.56) | |
| Anaphylactic reaction, anaphylactic shock, anaphylactoid reaction and hypersensitivity | 7 | (0.39) | |
| Fever | 7 | (0.39) | |
| Gastrointestinal perforation‡ | 7 | (0.39) | |
| Melaena | 7 | (0.39) | |
| Neutropenia | 6 | (0.33) | |
| Acute myocardial infarction | 6 | (0.33) | |
| RA | 6 | (0.33) | |
| Vertebral compression fracture | 6 | (0.33) | |
| Cerebral infarction | 5 | (0.28) | |
| Pneumothorax | 5 | (0.28) | |
| Leucopenia | 5 | (0.28) | |
| Disseminated intravascular coagulation | 4 | (0.22) | |
| Arthralgia | 4 | (0.22) | |
↵* Pneumonia: includes bronchial pneumonia, lobar pneumonia, pneumonia, mycoplasmal pneumonia, primary atypical pneumonia, bacterial pneumonia and pneumococcal pneumonia.
↵† Tuberculosis: pulmonary tuberculosis in three of the patients and peritoneal tuberculosis in one.
↵‡ Gastrointestinal perforations: includes appendicitis perforated, gastric perforation, intestinal perforation, large intestinal perforation, and small intestinal perforation.
ILD, interstitial lung disease; RA, rheumatoid arthritis; SAE, serious adverse event.