The effects of golimumab on subclinical atherosclerosis and arterial stiffness in ankylosing spondylitis--a randomized, placebo-controlled pilot trial

OBJECTIVE: Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS. METHODS: A randomized, double-blind, placebo-controlled pilot study was performed in which AS patients were treated with golimumab (n = 20) and placebo (n = 21) for 12 months. Patients from the placebo group who failed to achieve a 20% response to Assessment of SpondyloArthritis international Society criteria (ASAS20) at 6 months received open-label golimumab. Intima-media thickness (IMT), pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months. RESULTS: At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups achieved an ASAS20 response, respectively (P = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. In the placebo group, significantly greater progression of the mean IMT [from 0.51 mm (S.D. 0.07) at baseline to 0.53 mm (S.D. 0.08) at 6 months, P = 0.044] and PWV (from 12.2 m/s (S.D. 1.6) at baseline to 12.6 m/s (S.D. 1.3), P = 0.028] were observed. There was a trend towards progression of the mean IMT in the golimumab group (P = 0.099) but the maximum IMT, PWV and AIx remained unchanged. At 12 months the changes in vascular parameters were similar between the early and delayed (or no) golimumab groups. CONCLUSION: Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS. Arterial dysfunction may be prevented by golimumab over a period of 6 months, probably because of effective suppression of inflammation. TRIAL REGISTRATION: clinicaltrials.gov (NCT01212653)