Table 3

Changes from baseline to week 208 in mSASSS (employing linear extrapolation for missing data)

 Placebo→golimumab 50 mg*Golimumab
50 mg*100 mg*
Patients in radiographic substudy, n66111122
mSASSS change, by randomised group
 Mean±SD2.1±5.21.3±4.12.0±5.6
 Median (IQR)0.0 (0.0, 2.5)0.0 (0.0, 2.2)0.0 (0.0, 2.7)
  p Value for 50 vs 100 mg0.16
mSASSS change, by receipt of 50 mg vs 100 mg, n177122
 Mean±SD1.6±4.52.0±5.6
 Median (IQR)0.0 (0.0, 2.2)0.0 (0.0, 2.7)
  p Value for 50  vs 100 mg0.25
mSASSS change in patients with baseline syndesmophytes, n406871
 Mean±SD3.6±6.22.1±5.02.9±6.5
 Median (IQR)1.9 (0.0, 5.9)0.5 (−0.4, 4.0)1.5 (0.0, 6.1)
mSASSS change in patients without baseline syndesmophytes, n244245
 Mean±SD−0.1±0.50.1±0.90.4±1.6
 Median (IQR)0.0 (0.0, 0.0)0.0 (0.0, 0.0)0.0 (0.0, 0.0)
mSASSS change in all patients with baseline syndesmophytes, nAll patients 179
 Mean±SD2.8±5.9
 Median (IQR)1.1 (0.0, 5.2)
mSASSS change in all patients without baseline syndesmophytes, nAll patients 111
 Mean±SD0.2±1.2
 Median (IQR)0.0 (0.0, 0.0)
  p Value vs patients with baseline syndesmophytes<0.0001
mSASSS change >2, n (%)
 Proportions of patients by randomised treatment group19 (28.8%)29 (26.1%)35 (28.7%)
 Proportion of all patientsAll patients 83/299 (27.8%)
Annual progression rate at week 208 (change in mSASSS per year), Mean±SD0.5±1.30.4±1.70.5±1.4
  • *Patients in the placebo group started golimumab 50 mg at either week 16 (early escape) or week 24 (crossover) per protocol. Patients in the 50-mg group could escalate the golimumab dose to 100 mg at week 16 if they qualified for early escape. Patients in the 100-mg group continued to receive 100 mg regardless of early escape status.

  • †Defined as ≥1 level of spine with a score ≥2 (syndesmophytes) at baseline and a follow-up evaluation for ≥1 reader.

  • mSASSS, modified Stoke Ankylosing Spondylitis Spine Score.