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.
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Funding This study was funded by Centocor Research & Development, Inc. and Merck, Inc. (formerly Schering-Plough Research Institute, Inc.).
Competing interests XB belongs to the Spondyloarthritis Immunology Research Alliance (SpIRAL). AB was an employee of Centocor during the time this study was conducted. JB has received consulting fees, speaking fees, and/or honoraria from Centocor, Schering-Plough, Wyeth, Amgen, Abbott, Pfizer and Bristol-Myers Squibb. AAD has received payments for educational lectures, teleconferences and serving on advisory boards for Centocor, a company that may have a commercial interest in the results of this research. This potential conflict of interest has been reviewed and managed by Oregon Health and Science University. KGAH: none declared. RDI has served as a consultant for Abbott, Amgen-Wyeth, Centocor, Merck, Pfizer and Sanofi-Aventis. DvdH has received consulting fees and/or research grants from Abbott, Amgen, AstraZeneca, BMS, Centocor, Chugai, Eli-Lilly, GSK, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB and Wyeth. SX, WX and BH are employees of Centocor and own stock in its parent company (Johnson & Johnson).
Ethics approval The protocol was reviewed and approved by each site's institutional review board or independent ethics committee.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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