Article
ACHILLES – A randomized, double-blind, placebo-controlled multicenter study to demonstrate efficacy of secukinumab in the treatment of enthesitis in patients with active Psoriatic Arthritis and axial Spondyloarthritis
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Authors
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Frank Behrens
- CIRI am Klinikum der Johann Wolfgang Goethe-Universität, Rheumatologie, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
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Xenofon Baraliakos
- Rheumazentrum Ruhrgebiet, Herne
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Annette Wiedon
- Novartis Pharma GmbH, Nürnberg
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Claudia Jentzsch
- Novartis Pharma GmbH, Nürnberg
| Published: | September 4, 2017 |
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Outline
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Background: ACHILLES is the first IL17A-inhibitor study especially focusing on enthesitis as a hallmark feature in spondyloarthritis (SpA). The ACHILLES study will examine 200 patients across the SpA indications psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) for the complete resolution of their enthesitis and additionally investigates the heel inflammation with centrally read magnetic resonance imaging (MRI).
Methods: ACHILLES is a 52-week, randomized, parallel-group, double-blind, multicenter, international study consisting of an 8-week screening period, a 24-week, placebo-controlled, double-blind treatment period and a 28-week open-label treatment period. The study will enroll 200 patients with PsA, AS or nr-axSpA and MRI-positive heel enthesitis. Patients will be randomized 1:1 to either placebo or secukinumab and treated according to label (150 mg or 300 mg). MRI assessments will be performed at screening, Week 24 and Week 52 (end of study) and analyzed by central reading.
Results: Enrollment for the study started in August 2016 and will be finished in March 2018. First interpretable results are expected for March 2019. As primary endpoint the study aims to demonstrate that the efficacy of secukinumab is superior to placebo based on the percentage of patients with resolution of heel enthesitis as assessed by the respective subcomponent of the Leeds enthesitis index (LEI) at Week 24. As a main secondary endpoint the study evaluates the percentage of patients with an improvement of bone marrow edema in the insertion of the Achilles tendon in the upper part of the calcaneus and/or in the insertion of the plantar aponeurosis in the lower part of the calcaneus, quantified for edema based on the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS).
Conclusion: ACHILLES especially targets heel enthesitis as one of the major painful symptoms of many SpA patients. ACHILLES will especially generate objective and reliable data on enthesitis in MRI enabled by a centralized reading of repetitive standardized scans.
