Table 2

Baseline subject demographic and clinical characteristics in the total and uveitis populations*

CharacteristicsEtanercept†Placebo†Sulfasalazine†
Subjects with events (n = 68)All subjects (n = 1074)Subjects with events (n = 11)All subjects (n = 249)Subjects with events (n = 7)All subjects (n = 187)
Male, %82.474.372.777.585.774.9
Age, mean years42.441.140.641.144.040.9
Duration of AS diagnosis, mean years12.69.513.110.611.68.0
BASDAI, mean57.659.861.260.045.559.1
Concomitant medications, n (%)
    Sulfasalazine16 (23.5)135 (12.6)0 (0.0)64 (25.7)
    Hydroxychloroquine0 (0.0)6 (0.6)0 (0.0)3 (1.2)0 (0.0)0 (0.0)
    Methotrexate7 (10.3)125 (11.6)2 (18.2)31 (12.4)0 (0.0)19 (10.2)
History of uveitis, n (%)45 (66.2)164 (15.3)11 (100.0)54 (21.7)4 (57.1)24 (12.8)
HLA-B27+, n (%)63 (92.6)855 (79.6)10 (90.9)196 (78.7)7 (100)153 (81.8)
  • AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index.

  • *Some subjects who had an event while on placebo continued into the open-label extension studies. If a subject who continued in the open-label extension had an event, he/she was also counted in the etanercept group and the event and subsequent events were counted as etanercept group events; †subject–year exposures, 136.85, 82.97 and 54.3, etanercept, placebo and sulfasalazine, respectively.