Serious adverse events, malignancies and death, including crude incidence rates, SIRs and SMRs, in all adults with JIA starting first TNFi therapy
| All JIA | |
|---|---|
| Total follow-up available, years | 4422 |
| Mean (SD) follow-up per person, years | 10.0 (2.5) |
| Total exposure time on TNFi, years | 2799 |
| Mean (SD) exposure time on TNFi per person, years | 6.4 (3.4) |
| Serious infections | 58 |
| Rate (95% CI)/1000 pyrs | 22.3 (17.2 to 28.8) |
| Serious cardiovascular events | 4 |
| Rate (95% CI)/1000 pyrs | 1.4 (0.5 to 3.8) |
| Uveitis | 11 |
| Rate (95% CI)/1000 pyrs | 4.0 (2.2 to 7.3) |
| Malignancies | 16 |
| Rate (95% CI)/1000 pyrs | 3.7 (2.3 to 6.0) |
| SIR | 1.4 (0.9 to 2.3) |
| Deaths | 21* |
| Rate (95% CI)/1000 pyrs | 5.0 (3.2 to 7.6) |
| SMR | 2.5 (1.7 to 3.9) |
Death certificates were available in 20 of 21 deaths. The underlying causes of death were as follows: infection (4), cardiovascular disease (5: ischaemic heart disease (2), aortic stenosis (1), dilated cardiomyopathy (1), hypertensive encephalopathy (1)); end stage renal disease (1); peptic ulcer disease (1); lung cancer (1); underlying rheumatic disease (8: JIA (1); RA (5); PsA (1), AS (1)).
AS, ankylosing spondylitis; JIA, juvenile idiopathic arthritis; PsA, psoriatic arthritis; pyrs, person-years; RA, rheumatoid arthritis; SIR, standardised incidence ratio; SMR, standardised mortality ratio; TNFi, tumour necrosis factor inhibitor.