Incidence rate per 1000 person-years of main adverse events
| Rheumatoid arthritis | Spondyloarthritis | |||||||
| TNFi | JAKi | TNFi | JAKi | |||||
| Total exposure time (years) | 6432.3 | 3165.1 | 10 302.9 | 375.8 | ||||
| Type of adverse event | IR (95% CI) | IR (95% CI) | Crude IRR (95% CI) | Adjusted IRR (95% CI) | IR (95% CI) | IR (95% CI) | Crude IRR (95% CI) | Adjusted IRR (95% CI) |
| Mortality* | 4.4 (3.0 to 6.3) | 6.0 (3.8 to 9.4) | 1.4 (0.8 to 2.5) P=0.28 | 1.2 (0.7 to 2.3) P=0.55 | 1.4 (0.8 to 2.3) | 2.7 (0.4 to 18.9) | 2.0 (0.3 to 14.9) P=0.52 | 0.7 (0.1 to 5.7) P=0.69 |
| Malignancies* | 19.9 (16.7 to 23.7) | 19.9 (15.5 to 25.5) | 1.0 (0.7 to 1.4) P=0.99 | 0.9 (0.6 to 1.2) P=0.43 | 13.4 (11.3 to 15.8) | 10.6 (4.0 to 28.4) | 0.8 (0.3 to 2.2) P=0.65 | 0.9 (0.3 to 2.5) P=0.83 |
| All infections | 221.8 (210.6 to 233.7) | 280.9 (263.0 to 300.0) | 1.3 (1.2 to 1.4) P<0.001 | 1.1 (1.0 to 1.3) P=0.005 | 170.5 (162.7 to 178.7) | 250.1 (204.4 to 306.2) | 1.5 (1.2 to 1.8) P<0.001 | 1.2 (1.0 to 1.5) P=0.078 |
| Serious infections | 30.9 (26.9 to 35.5) | 49.3 (42.1 to 57.7) | 1.6 (1.3 to 2.0) P<0.001 | 1.1 (0.9 to 1.4) P=0.37 | 18.8 (16.4 to 21.7) | 18.6 (8.9 to 39.1) | 1.0 (0.5 to 2.1) P=0.98 | 0.7 (0.3 to 1.4) P=0.28 |
| Herpes zoster | 8.7 (6.7 to 11.3) | 18.6 (14.4 to 24.1) | 2.1 (1.5 to 3.1) P<0.001 | 2.2 (1.5 to 3.3) P<0.001 | 4.8 (3.6 to 6.3) | 10.6 (4.0 to 28.4) | 2.2 (0.8 to 6.2) P=0.12 | 1.6 (0.5 to 4.7) P=0.41 |
| Tuberculosis | 1.4 (0.7 to 2.7) | 0.3 (0.0 to 2.2) | 0.2 (0.0 to 1.8) P=0.16 | 0.2 (0.0 to 1.4) P=0.10 | 0.3 (0.1 to 0.9) | 0.0 (0.0 to 0.0) | ||
| Cardiac | 11.0 (8.7 to 13.9) | 15.8 (12.0 to 20.8) | 1.7 (1.1 to 2.4) P=0.008 | 1.1 (0.7 to 1.6) P=0.71 | 8.3 (6.7 to 10.2) | 8.0 (2.6 to 24.8) | 1.0 (0.3 to 3.1) P=0.96 | 0.9 (0.3 to 3.0) P=0.89 |
| Thrombotic/vascular | 11.6 (9.6 to 14.1) | 17.2 (11.6 to 25.5) | 1.4 (1.0 to 2.1) P=0.052 | 1.3 (0.9 to 2.0) P=0.16 | 7.5 (6.0 to 9.3) | 8.0 (2.6 to 24.8) | 1.1 (0.3 to 3.4) P=0.91 | 0.9 (0.3 to 2.9) P=0.83 |
| Pulmonary | 30.2 (26.2 to 34.7) | 38.9 (32.6 to 46.4) | 1.3 (1.0 to 1.6) P=0.028 | 1.1 (0.9 to 1.4) P=0.39 | 22.0 (19.3 to 25.1) | 29.3 (16.2 to 52.9) | 1.3 (0.7 to 2.4) P=0.36 | 1.5 (0.8 to 2.8) P=0.28 |
| Gastrointestinal | 31.2 (27.2 to 35.9) | 50.6 (43.3 to 59.0) | 1.6 (1.3 to 2.0) P<0.001 | 1.5 (1.2 to 1.8) P=0.001 | 39.0 (35.4 to 43.0) | 55.9 (36.4 to 85.7) | 1.4 (0.9 to 2.2) P=0.11 | 1.3 (0.8 to 2.1) P=0.28 |
| Gastrointestinal perforation | 2.5 (1.5 to 4.1) | 3.8 (2.2 to 6.7) | 1.5 (0.7 to 3.2) P=0.27 | 1.1 (0.5 to 2.4) P=0.90 | 1.8 (1.2 1 to 2.8) | 0.0 (0.0 to 0.0) | ||
Adjusted IRR by age, sex, years of disease and Charlson Comorbidity Index, line of treatment, concomitant use of methotrexate, concomitant use of glucocorticoids and disease activity at baseline.
p<0.05 are shown in bold.
*Mortality and malignancy events followed the ‘ever taken drug’ risk attribution model. All the remaining adverse events were attributed to a drug while the patient was actively receiving therapy plus a lag window beyond drug discontinuation.
IR, incidence rate (per 1.000 patient-years); IRR, incidence rate ratio (calculated using the TNFi as reference); JAKi, Janus kinase inhibitor; TNFi, tumour necrosis factor inhibitor.