Risk factors for AE (results based on multiple logistic regression analysis)
| Event | Factor | Prevalence*(%) | OR | 95% CI | p Value | |
|---|---|---|---|---|---|---|
| Serious infections and infestations | Age, years (≥65 vs <65)† | 75/1406 (5.33) | 70/2473 (2.83) | 1.699 | 1.152 to 2.505 | 0.0075 |
| Respiratory disease (concurrent or medical history) (yes vs no) | 68/841 (8.09) | 77/3040 (2.53) | 3.428 | 2.308 to 5.092 | <0.0001 | |
| Oral corticosteroids (mg/day, prednisolone-equivalent) (at baseline) | ||||||
| (<5 mg/day vs 0 mg/day) | 58/1845 (3.14) | 25/1032 (2.42) | 1.114 | 0.647 to 1.915 | 0.6973 | |
| (≥5 mg/day vs 0 mg/day) | 62/1004 (6.18) | 25/1032 (2.42) | 2.165 | 1.254 to 3.738 | 0.0056 | |
| ILD‡ | Age, years (≥65 vs <65)† | 16/1406 (1.14) | 7/2473 (0.28) | 4.304 | 1.532 to 12.091 | 0.0056 |
| ILD (concurrent or medical history) (yes vs no)no | 13/428 (3.04) | 10/3453 (0.29) | 7.950 | 3.129 to 20.200 | <0.0001 | |
| Hepatic function disorders§ | Methotrexate (concomitant drug) (yes vs no) | 214/1942 (11.02) | 106/1939 (5.47) | 2.174 | 1.705 to 2.771 | <0.0001 |
| Hepatic function disorders (concurrent) (yes vs no) | 30/176 (17.05) | 290/3705 (7.83) | 2.546 | 1.681 to 3.857 | <0.0001 | |
| Cardiac function disorders | Cardiac function disorders (concurrent or medical history) (yes vs no) | 13/250 (5.20) | 11/3631 (0.30) | 15.618 | 6.054 to 40.294 | <0.0001 |
| Bodyweight (>40 kg vs ≤40 kg)† | 16/3232 (0.50) | 6/234 (2.56) | 0.235 | 0.077 to 0.717 | 0.0416 | |
| Death | Age, years (≥65 vs <65)† | 20/1406 (1.42) | 5/2473 (0.20) | 3.274 | 1.161 to 9.232 | 0.0249 |
| Steinbrocker class (3+4 vs 1+2) | 17/1037 (1.64) | 8/2831 (0.28) | 3.505 | 1.361 to 9.027 | 0.0094 | |
| Cardiac disorders (concurrent or medical history) (yes vs no) | 8/250 (3.20) | 17/3631 (0.47) | 3.607 | 1.422 to 9.146 | 0.0069 | |
| Renal impairment (concurrent) (yes vs no) | 9/187 (4.81) | 16/3694 (0.43) | 3.876 | 1.354 to 11.098 | 0.0116 | |
↵* Prevalence is described as (number of patients who developed adverse events; AE)/(number of patients matched with each factor).
↵† Data were not collected in two cases.
↵‡ ILD (interstitial lung disease) includes interstitial pneumonia and organising pneumonia.
↵§ Hepatic function disorders include liver function test abnormalities (increased levels of aspartate aminotransferase, alanine aminotransferase, or γ-glutamyl transpeptidase).