Table 3 Adverse events
Before TCZ initiation (N = 60) | After TCZ initiation (N = 60) | |
|---|---|---|
AEs reported in ≥ 2 patients, n (%) | ||
AEs attributed to glucocorticoids | ||
Cataract | 3 (5.0) | 4 (6.7) |
Impaired glucose metabolism | 5 (8.3) | 3 (5.0) |
Psychiatric complications* | 9 (15.0) | 1 (1.7) |
Gastroesophageal reflux disease | 3 (5.0) | 0 |
Gastrointestinal hemorrhage | 1 (1.7) | 2 (3.3) |
Myopathy | 4 (6.7) | 1 (1.7) |
Osteopenia | 5 (8.3) | 1 (1.7) |
Atrial fibrillation | 1 (1.7) | 2 (3.3) |
Hypertension | 1 (1.7) | 2 (3.3) |
Cardiac failure | 2 (3.3) | 0 |
AEs attributed to glucocorticoids and/or TCZ | ||
Dyslipidemia | 0 | 2 (3.3) |
Pneumonia | 4 (6.7) | 4 (6.7) |
Urinary tract infection | 1 (1.7) | 2 (3.3) |
Sinusitis | 0 | 2 (3.3) |
Herpes zoster infection | 2 (3.3) | 1 (1.7) |
AEs attributed to TCZ | ||
Leukopenia | 0 | 3 (5.0) |
Thrombocytopenia | 0 | 2 (3.3) |
Increased transaminases | 0 | 3 (5.0) |
AEs unrelated to glucocorticoids and/or TCZ | ||
Osteoarthritis | 0 | 3 (5.0) |
Musculoskeletal pain | 0 | 3 (5.0) |
Deep vein thrombosis | 0 | 2 (3.3) |
Lumbar radiculopathy | 0 | 2 (3.3) |
SAEs reported in ≥ 1 patient, n (%) | 6 (10.0) | 6 (10.0) |
SAEs attributed to glucocorticoids | ||
Diabetic ketoacidosis | 0 | 1 (1.7) |
Gastrointestinal hemorrhage | 0 | 2 (3.3) |
Osteoporotic hip fracture | 1 (1.7) | 0 |
Depression | 1 (1.7) | 0 |
Atrial fibrillation | 1 (1.7) | 1 (1.7) |
Cardiac failure | 2 (3.3) | 0 |
SAEs attributed to glucocorticoids and/or TCZ | ||
Pneumocystis jiroveci pneumonia | 1 (1.7) | 0 |
Sepsis | 0 | 1 (1.7) |
SAEs attributed to TCZ | ||
Leukopenia | 0 | 1 (1.7) |
Intestinal perforation | 0 | 1 (1.7) |
SAEs unrelated to glucocorticoids and/or TCZ | ||
Acute kidney injury | 0 | 1 (1.7) |
Leiomyosarcoma | 0 | 1 (1.7) |
Pneumonitis | 1 (1.7) | 0 |
Pulmonary embolism | 1 (1.7) | 0 |