Table 4.
Serious adverse events | Hazard ratio (95% CI)a | |
---|---|---|
US cohort (N = 4804)b | UK cohort (N = 3973)c | |
GC-related AEsd | ||
Any GC-related event | 1.08 (1.00, 1.16)e | 1.03 (1.02, 1.04)e |
Blood pressure | 1.04 (1.01, 1.07)e | 1.00 (0.98, 1.01) |
Endocrine | 1.05 (1.02, 1.09)e | 1.09 (1.01, 1.17)e |
Bone-related conditions | 1.03 (1.01, 1.04)e | 1.02 (1.01, 1.03)e |
Muscle and tendon | 1.04 (1.00, 1.07) | 1.06 (1.03, 1.10)e |
Eye | 1.04 (1.02, 1.06)e | 1.04 (1.03, 1.05)e |
Glucose tolerance | 1.05 (1.03, 1.06)e | 1.02 (1.01, 1.04)e |
Gastrointestinal tract | 1.00 (0.91, 1.10) | 1.02 (0.99, 1.06) |
Skin | 1.04 (1.02, 1.05)e | 1.03 (1.01, 1.04)e |
Neuropsychiatric | 1.03 (1.01, 1.05)e | 1.01 (0.99, 1.02) |
Other SAEs | ||
Adrenal insufficiency | 1.05 (1.02, 1.09)e | 1.00 (0.81, 1.24) |
Anemia | 1.02 (1.01, 1.04)e | 1.02 (1.01, 1.04)e |
Cataracts | 1.03 (1.01, 1.05)e | 1.04 (1.03, 1.05)e |
Cerebrovascular disease | 1.01 (0.98, 1.04) | 1.00 (0.99, 1.02) |
Depression | 1.02 (1.00, 1.05)e | 1.01 (1.00, 1.03) |
Diabetes | 1.05 (1.03, 1.07)e | 1.03 (1.01, 1.05)e |
Fracture | 1.02 (1.00, 1.04)e | 1.01 (1.00, 1.03) |
Gastrointestinal perforation | 1.04 (0.98, 1.09) | 1.09 (0.99, 1.20) |
Glaucoma | 1.03 (0.98, 1.08) | 1.02 (1.00, 1.05) |
Liver disease | 1.03 (0.95, 1.12) | NA |
Myocardial infarction | 1.01 (0.99, 1.04) | 1.01 (0.99, 1.03) |
Osteoporosis | 1.03 (1.02, 1.05)e | 1.03 (1.01, 1.04)e |
Serious infections | 1.03 (1.02, 1.04)e | 1.02 (1.01, 1.04)e |
Any AESI to tocilizumab | 1.02 (1.01, 1.04)e | 1.01 (1.01, 1.02)e |
AE adverse event, AESI adverse event of special interest, GC glucocorticoid, NA not available, SAE serious adverse event
aRegression adjusted for covariates of age, sex, Charlson Comorbidity Index, and previous disease history
bMean (median) follow-up duration for the US cohort was 3.9 (3.1) years
cMean (median) follow-up duration for the UK cohort was 6.3 (5.5) years
dClasses of AEs included in the evaluation of the Glucocorticoid Toxicity Index [24]
eP < 0.05