Golimumab reduces spinal inflammation in ankylosing spondylitis: MRI results of the randomised, placebo- controlled GO-RAISE study

Abstract

Objective: To evaluate golimumab's effect on MRI-detected spinal inflammation in ankylosing spondylitis (AS).

Methods: Patients were randomly assigned to subcutaneous injections of placebo (n=78), golimumab 50 mg (n=138), or golimumab 100 mg (n=140) every 4 weeks. An MRI substudy comprising 98 patients (placebo n=23, 50 mg n=37, 100 mg n=38) at eligible MRI substudy sites had serial spine MRI scans (sagittal plane, 1.5T scanners, T1 and short tau inversion recovery sequences) at baseline and weeks 14 and 104. Two blinded (treatment, image order) readers independently evaluated MRI spinal inflammation using AS spine MRI-activity (ASspiMRI-a) scores; reader scores were averaged. Changes from baseline to weeks 14 and 104 were compared among treatment groups using analysis of variance on van der Waerden normal scores both with (post-hoc) and without (prespecified) adjustment for baseline ASspiMRI-a scores.

Results: Median baseline ASspiMRI-a scores were lower in the 100 mg (3.5) than placebo (6.8) and 50 mg (7.8) groups. Median decreases in activity scores from baseline to week 14 were -0.5 for placebo, -3.5 for 50 mg (p=0.047 vs placebo), and -1.5 for 100 mg (p=0.14 vs placebo). After adjusting for baseline ASspiMRI-a score imbalance, significant improvements were observed with both 50 mg (p=0.011) and 100 mg (p=0.002) versus placebo. ASspiMRI-a scores improvement achieved with golimumab was maintained at week 104. Improvement in ASspiMRI-a scores correlated with improvement in the recently developed AS disease activity score (ASDAS) and C-reactive protein (CRP) levels but not with other key AS clinical outcomes.

Conclusion: Golimumab significantly reduced MRI-detected spinal inflammation of AS; improvements were sustained to week 104 and correlated with improvement in ASDAS and CRP.

Figure 1

Panel A: Cumulative probability of changes in ASspiMRI-a scores from baseline to week 14 for each treatment group. Each data point represents the change from baseline for an individual patient. Panels B and C: Double probability plots for the placebo and combined golimumab groups, respectively, showing the baseline ASspiMRI-a score plotted on top of the corresponding change from baseline to week 14 for each individual patient.

Figure 2

Magnetic resonance images of the cervical (C) and thoracic (T) spine at baseline (Panel A), week 14 (Panel B) and week 104 (Panel C) of a patient who received golimumab 50 mg followed by early escape at week 16 to golimumab 100 mg. These sagittal Short Tau Inversion Recovery (STIR) images show active lesions at multiple vertebral units, particularly at C7/T1 and T6/T7 at baseline (Panel A). The activity in the spine was markedly decreased at week 14 (Panel B) and resolved at nearly all levels at week 104 (Panel C). Note: Series of consecutive images were evaluated; the images displayed here are representative but not exhaustive.