Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: Results from a phase 3b trial
Rheumatology Nov 09, 2021
Behrens F, Sewerin P, de Miguel E, et al. - In this study (ACHILLES) of secukinumab for Achilles’ tendon enthesitis in spondyloarthritis (SpA) patients, the primary endpoint was not met but patient-related outcomes showed clinically meaningful improvements. Centrally-read MRIs demonstrated absence of inflammation signs in a substantial proportion of patients despite a clinical diagnosis of heel-enthesitis.
A total of 204 patients ≥18 years with active psoriatic arthritis or axial SpA and heel-enthesitis were included and were randomly assigned 1:1 to secukinumab 150/300 mg or placebo up to week 24, after that placebo patients were switched to secukinumab.
Resolution of Achilles tendon enthesitis in affected foot was evident in a higher yet statistically non-significant proportion of patients in secukinumab vs placebo at week 24 (42.2% vs 31.4%; OR = 1.63).
With secukinumab vs placebo, higher mean change from baseline in heel-pain was noted at week 24 (−2.8 ± 3.0 vs −1.9 ± 2.7), and secukinumab provided greater improvements in heel-enthesopathy activity and global assessment of disease activity.
Imaging assessment via local reading corroborated heel-enthesitis on MRI at screening for all cases.
By central reading, bone marrow edema and/or tendinitis was present in 56%; based on Heel Enthesitis MRI Scoring System post-hoc analysis, 76% showed signs of entheseal inflammation while 86% exhibited entheseal inflammation and/or structural alterations.
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