Changes from baseline to week 104 in mSASSS (observed data)
| Placebo→golimumab 50 mg* | Golimumab | ||
|---|---|---|---|
| 50 mg* | 100 mg* | ||
| Patients in radiographic substudy, n | 66 | 111 | 122 |
| mSASSS change | |||
| Mean±SD | 1.6±4.6 | 0.9±2.7 | 0.9±3.9 |
| 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,† n | 40 | 68 | 71 |
| Mean±SD | 2.6±5.8 | 1.4±3.3 | 1.3±4.8 |
| 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,† n | 24 | 42 | 45 |
| Mean±SD | 0.1±0.4 | −0.0±0.7 | 0.3±1.2 |
| 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,† n | All patients 179 | ||
| Mean±SD | 1.6±4.6 | ||
| Median (IQR) | 0.5 (−0.6, 3.9) | ||
| mSASSS change in all patients without baseline syndesmophytes,† n | All patients 111 | ||
| Mean±SD | 0.1±0.9 | ||
| Median (IQR) | 0.0 (0.0, 0.0) | ||
| p Value vs patients with baseline syndesmophytes | 0.0348 | ||
| Annual progression rate at week 104 (change in mSASSS per year), Mean±SD | 0.8±2.2 | 0.4±1.3 | 0.4±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.