Rates of AESIs and SAEs among patients with JPsA during observed etanercept use, overall and stratified by sex (incidence rates/100 PYs)
| Adverse event type | Female (N=126; PYs=341.2) | Male (N=65; PYs=209.2) | Total (N=191; PYs=550.4) | ||||||
| n | Rate | 95% CI | n | Rate | 95% CI | n | Rate | 95% CI | |
| AESIs* | |||||||||
| Uveitis | 1 | 0.29 | 0.04, 2.08 | 2 | 0.96 | 0.24, 3.82 | 3 | 0.55 | 0.18, 1.69 |
| Infections treated with intravenous anti-infectives | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SAEs† | 1 | 0.29 | 0.04, 2.08 | 0 | 0 | 0, NC | 1 | 0.18 | 0.03, 1.29 |
| New-onset neuropathy | 1 | 0.29 | 0.04, 2.08 | 0 | 0 | 0, NC | 1 | 0.18 | 0.03, 1.29 |
| Malignancy‡ | |||||||||
| Any malignancy | 1 | 0.20 | 0.03, 1.43 | 0 | 0 | 0, NC | 1 | 0.13 | 0.02, 0.90 |
N=number of patients who met the criteria for the safety cohort, that is, had a rheumatologist-diagnosed JIA category of PsA, did not have ongoing concurrent biologic use at etanercept initiation and had observed time on etanercept during CARRA Registry enrolment; n=number of AESIs or SAEs.
*Thirty-one AEs were prespecified as AESIs (see online supplemental table 1), including any malignancy and uveitis but malignancy was reported separately.
†Any AE meeting serious criteria; malignancy and uveitis were included in the case report form and therefore ‘solicitated’ as part of the AESIs, but malignancy was reported separately.
‡Malignancy was reported separately as the follow-up period for time at risk was different from that for AESIs and SAEs; PY=494.8 for females, 294.4 for males and PY=789.2 for total.
AE, adverse event; AESIs, adverse events of special interest; CARRA, Childhood Arthritis and Rheumatology Research Alliance; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; NC, not calculable; PsA, psoriatic arthritis; PY, person-year; SAEs, serious adverse events.