Table 4.
Risk of OCS‐related AEs by organ domain during the 12‐month observation period in the OCS‐initiator cohort exposure categories and the no‐OCS‐use cohort (N = 27,352)
| No OCS use (n = 11,136) | Number of exposure categories of OCS use >5 mg/day | |||
|---|---|---|---|---|
| 0 (n = 11,438) | 1 (n = 3048) | 2 (n = 1730) | ||
| Any OCS‐related AE | ||||
| Incidence, % | 56.3 | 67.1 | 70.5 | 74.1 |
| Adjusted RR (95% CI) | — | 1.15 (1.10‐1.20) | 1.23 (1.15‐1.31) | 1.32 (1.22‐1.43) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Bone and muscle | ||||
| Incidence, % | 21.5 | 28.3 | 28.0 | 31.7 |
| Adjusted RR (95% CI) | — | 1.28 (1.21‐1.35) | 1.30 (1.19‐1.41) | 1.50 (1.36‐1.64) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Immune system related | ||||
| Incidence, % | 18.5 | 26.1 | 32.1 | 37.6 |
| Adjusted RR (95% CI) | — | 1.36 (1.29‐1.44) | 1.61 (1.49‐1.74) | 1.88 (1.71‐2.05) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Central nervous system | ||||
| Incidence, % | 18.3 | 25.0 | 23.9 | 24.9 |
| Adjusted RR (95% CI) | — | 1.31 (1.23‐1.39) | 1.25 (1.14‐1.37) | 1.30 (1.16‐1.46) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Metabolic and endocrine | ||||
| Incidence, % | 18.0 | 20.6 | 22.2 | 26.0 |
| Adjusted RR (95% CI) | — | 1.13 (1.06‐1.21) | 1.23 (1.12‐1.35) | 1.44 (1.29‐1.60) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Cardiovascular | ||||
| Incidence, % | 15.4 | 18.1 | 23.1 | 31.3 |
| Adjusted RR (95% CI) | — | 1.16 (1.08‐1.25) | 1.51 (1.36‐1.67) | 2.11 (1.89‐2.37) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Gastrointestinal | ||||
| Incidence, % | 10.7 | 16.0 | 21.1 | 22.6 |
| Adjusted RR (95% CI) | — | 1.42 (1.32‐1.53) | 1.66 (1.50‐1.84) | 1.65 (1.46‐1.86) |
| P value | — | <0.01 | <0.01 | <0.01 |
| Ophthalmologic | ||||
| Incidence, % | 7.9 | 7.7 | 8.7 | 11.0 |
| Adjusted RR (95% CI) | — | 1.05 (0.95‐1.15) | 1.30 (1.14‐1.49) | 1.78 (1.53‐2.08) |
| P value | — | 0.36 | <0.01 | <0.01 |
| Dermatologic | ||||
| Incidence, % | 2.6 | 3.1 | 4.0 | 4.4 |
| Adjusted RR (95% CI) | — | 1.12 (0.96‐1.31) | 1.25 (1.01‐1.56) | 1.21 (0.94‐1.57) |
| P value | — | 0.15 | 0.04 | 0.15 |
| Hematologic/oncologic | ||||
| Incidence, % | 1.7 | 2.7 | 5.1 | 6.3 |
| Adjusted RR (95% CI) | — | 1.56 (1.30‐1.87) | 2.56 (2.05‐3.20) | 3.10 (2.40‐4.02) |
| P value | — | <0.01 | <0.01 | <0.01 |
Notes: One patient with unknown sex in the OCS nonuser cohort was excluded from the adjusted analyses. AEs with incidence of ≥3% that are included in the organ‐level analyses and analyzed individually are back pain, osteoporosis, fractures, muscle weakness, varicella/herpes zoster, urinary tract infection, sepsis, fungal infections, pneumonia, depression, sleep disturbance, migraine, dyslipidemia, obesity, diabetes mellitus, hyperglycemia, hypertension, nausea/vomiting, gastrointestinal bleeds/ulcers, cataracts, and glaucoma. AEs with incidence <3% that are included in the organ domain‐level analyses but not analyzed individually are bursitis, avascular necrosis, loss of muscle mass, myopathy, myocardial infarction, atrial fibrillation/flutter, congestive heart failure, stroke, bipolar disorder, steroid psychosis, akathisia, acne, hirsutism, erythema, dyspepsia, acute pancreatitis, abdominal distension, bladder cancer, epistaxis, leukocytosis, tuberculosis, metabolic syndrome, Cushing syndrome, and drug‐induced adrenocortical insufficiency. Modified Poisson regression models, controlling for the baseline covariates sex, age on index date, geographic region, baseline total health care costs, baseline Charlson Comorbidity Index, baseline use of prescription drugs, baseline disease severity, and baseline flares, were used to calculate RRs; the respective P values and 95% CIs were estimated with the robust variance estimator.
Abbreviations: AE, adverse event; CI, confidence interval; OCS, oral corticosteroid; RR, risk ratio.