Table 2

Changes from baseline to week 104 in mSASSS (observed data)

Placebo→golimumab 50 mg*Golimumab
50 mg*100 mg*
Patients in radiographic substudy, n66111122
mSASSS change
 Median (IQR)0.0 (0.0, 2.2)0.0 (−0.5, 1.2)0.0 (−0.2, 2.0)
mSASSS change in patients with baseline syndesmophytes, n406871
 Median (IQR)1.3 (−1.1, 5.8)0.5 (−0.9, 3.2)0.4 (−0.5, 3.0)
mSASSS change in patients without baseline syndesmophytes, n244245
 Median (IQR)0.0 (0.0, 0.0)0.0 (−0.4, 0.0)0.0 (0.0, 0.0)
mSASSS change in all patients with baseline syndesmophytes, nAll patients 179
 Median (IQR)0.5 (−0.6, 3.9)
mSASSS change in all patients without baseline syndesmophytes, nAll patients 111
 Median (IQR)0.0 (0.0, 0.0)
  p Value vs patients with baseline syndesmophytes0.0348
Annual progression rate at week 104 (change in mSASSS per year), Mean±SD0.8±2.20.4±1.30.4±1.8
  • *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.