Table 2.

Extent of exposure and followup through 5 years: pooled data across 5 phase 3 studies of SC GOL (with or without MTX) in RA (3 trials), PsA (1 trial), and AS (1 trial). Values are mean/median unless stated otherwise.

VariablesPlaceboGOL 50 mg OnlyGOL 50 and 100 mgGOL 100 mg OnlyGOL Combined
5 trials: 3 RA, 1 PsA, 1 AS
  No. treated patients16396717657922228
  No. SC injections6.6/6.042.6/57.052.9/60.045.3/61.047.1/58.0
  Weeks of safety followup228.5/24.0184.0/240.1227.5/255.7195.9/257.3203.2/252.4
  Total patient-yrs of followup3502374334629828702
  Cumulative GOL dose, mg0.0/0.02132/28504376/48504525/61003753/3600
3 RA trials
  No. treated patients14493745425651481
  No. SC injections7.4/6.039.4/51.051.5/58.043.2/60.045.3/57.0
  Weeks of safety followup232.2/24.0172.0/216.3223.0/252.1188.3/257.0196.9/244.9
  Total patient-yrs of followup2781237232320445604
  Cumulative GOL dose, mg0.0/0.01967/25254242/46254318/60003697/3650
  • 1 Note that some patients received placebo followed by GOL in early escape or following crossover per trial design.

  • 2 Including posttreatment followup. SC: subcutaneous; GOL: golimumab; MTX: methotrexate; RA: rheumatoid arthritis; PsA: psoriatic arthritis; AS: ankylosing spondylitis.