Table 3

Rates of AESIs and SAEs among patients with JPsA during observed etanercept use, overall and stratified by sex (incidence rates/100 PYs)

Adverse event typeFemale
(N=126; PYs=341.2)
(N=65; PYs=209.2)
(N=191; PYs=550.4)
nRate95% CInRate95% CInRate95% CI
 Uveitis10.290.04, 2.0820.960.24, 3.8230.550.18, 1.69
 Infections treated with intravenous anti-infectives000000000
SAEs†10.290.04, 2.08000, NC10.180.03, 1.29
 New-onset neuropathy10.290.04, 2.08000, NC10.180.03, 1.29
 Any malignancy10.200.03, 1.43000, NC10.130.02, 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.