Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in ankylosing spondylitis

摘要: Objectives To evaluate the efficacy and safety of an oral phosphodiesterase 4 inhibitor, apremilast, in treatment ankylosing spondylitis (AS) by monitoring symptoms signs a pilot study including exploratory investigation effects PDE4 inhibition on blood biomarkers bone biology. Methods In this double-blind, placebo-controlled, single-centre, Phase II study, patients with symptomatic AS active disease MRI were randomised to apremilast 30 mg BID or placebo over 12 weeks. Bath Indices monitored serially. Patients followed for weeks after stopping medication. Bone assessed at baseline day 85. Results 38 subjects 36 completed study. Although primary end-point (change BASDAI week 12) was not met, associated numerically greater improvement from all clinical assessments compared mean change (−1.59±1.48 vs −0.77±1.47), BASFI (−1.74±1.91 −0.28±1.61) BASMI (−0.51±1.02 −0.21±0.67); however, differences did achieve statistical significance. The indices returned values cessation apremilast. Six (35.3%) 3 (15.8%) achieved ASAS20 responses (p=0.25). There statistically significant decreases serum RANKL RANKL:osteoprotegrin ratio plasma sclerostin but no changes DKK-1, alkaline phosphatase, TRAP5b, MMP3, osteoprotegrin, osteocalcin. Conclusions small these results suggest that may be effective well tolerated modulates These data support further research axial inflammation.