Background Data from observational studies showed that the effects of long-term anti-TNF-α therapy on arterial stiffness and intima-media thickness (IMT) progression in patients with ankylosing spondylitis (AS) were inconsistent.
Objectives To ascertain the efficacy of with golimumab compared to placebo in the prevention of atherosclerosis and arterial stiffness in patients with AS.
Methods A randomized, double-blind, placebo-controlled study in which AS patients with active disease were treated with golimumab 50mg daily (n=20) and placebo (n=21) for 12 months. Patients were assessed every 3 monthly. Patients from the placebo group who failed to achieve ASAS20 response at 6 months were permitted to escape to receive open-label golimumab. IMT, pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months. We hereby report the results of the first 6 months.
Results At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups respectively achieved an ASAS 20 response (p = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. Nonetheless, within group comparison showed that in the placebo group, significantly greater progression of the mean IMT (from 0.51 ± 0.07 mm at baseline to 0.53 ± 0.08 mm at 6 months, p = 0.044) and PWV (from 12.2± 1.6 m/s at baseline to 12.6 ± 1.3m/s, p = 0.028) were observed in the placebo group, while the maximum IMT (from 0.54 ± 0.08 mm at baseline to 0.56 ± 0.10 mm at 6 months, p = 0.085) and AIx (12.4 ± 10.3% at baseline to 11.6 ± 10.9%, p=0.7) remained unchanged. The vascular parameters of the golimumab group remained unchanged (mean IMT from 0.52 ± 0.07 mm at baseline to 0.54 ± 0.09 mm at 6 months, p = 0.099; maximum IMT from 0.56 ± 0.09 mm at baseline to 0.56 ± 0.10 mm at 6 months, p = 0.852; AIx from 11.4 ± 11.8 % at baseline to 13.1 ± 10.9 %, p=0.454; and PWV from 12.4 ± 1.5m/s at baseline to 12.4 ± 1.6 m/s, p = 0.855). Compared with the placebo group, there was a significantly greater reduction in the laboratory parameters of inflammation (ESR and CRP), accompanied by significantly greater reduction in the physician’s global assessment, pain and BASDAI in the golimumab group. Significantly greater increase in the total cholesterol (TC) and high density lipoprotein (HDL) cholesterol levels were observed in the golimumab group, nonetheless, no significant differences in the changes of the TC/HDL or other cardiovascular risk factors were observed between the two groups
Conclusions Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS, which may be prevented by golimumab over a period of 6-month, suggesting that effective suppression of inflammation may prevent progression of subclinical atherosclerosis and improving vascular function.
Acknowledgements This study is supported by an educational grant from Janssen Pharmaceutical (Hong Kong). The study drugs were provided by Janssen Pharmaceutical (Hong Kong).
Disclosure of Interest None Declared