Evidence map›Paper›PMID 35578245›Full record

Trial reportArthritis research & therapy2022

Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial.

X Baraliakos, P Sewerin, E de Miguel, E Pournara, C Kleinmond, A Shekhawat, C Jentzsch, A Wiedon, F Behrens, ACHILLES study group

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02771210 (A Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy in the Treatment of Enthesitis at the Achilles Tendon up to 1 Year in Adult Patients With Active Psoriatic Arthritis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02771210 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy in the Treatment of Enthesitis at the Achilles Tendon up to 1 Year in Adult Patients With Active Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA) (ACHILLES)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2019Enrolled204ConditionsPsoriatic Arthritis, Axial Spondyloarthritis, EnthesitisArmsSecukinumab, Secukinumab Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 4 countries.

X Baraliakos *Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany. xenofon.baraliakos@elisabethgruppe.de.
P Sewerin *Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany.
E de MiguelRheumatology Department, Hospital Universitario La Paz, Madrid, Spain.
E PournaraNovartis Pharma AG, Basel, Switzerland.
C KleinmondClinProject GmbH, Eurasburg, Germany.
A ShekhawatNovartis Healthcare Private Limited, Hyderabad, India.
C JentzschNovartis Pharma GmbH, Nürnberg, Germany.
A WiedonNovartis Pharma GmbH, Nürnberg, Germany.
F BehrensCIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.
ACHILLES study group
Novartis (Germany) · DEFraunhofer Institute for Translational Medicine and Pharmacology · DEHeinrich Heine University Düsseldorf · DEHospital Universitario La Paz · ESNovartis (India) · INNovartis (Switzerland) · CHRuhr University Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the imaging characteristics and clinically assess heel enthesitis in spondyloarthritis (SpA) by applying in a post hoc analysis the Heel Enthesitis Magnetic Resonance Imaging Scoring system (HEMRIS) in blinded and centrally-read MRI data from the ACHILLES trial (NCT02771210).

methodsACHILLES included patients (≥18 years) with active psoriatic arthritis or axial SpA with clinical and MRI-positive heel enthesitis refractory to standard treatment. Patients were randomized to receive subcutaneous secukinumab 150/300 mg or placebo. At week 24, patients on placebo were switched to secukinumab treatment. MRI-positive heel enthesitis was confirmed in all patients by local investigators. MRIs were performed at 3 timepoints: screening and weeks 24 and 52. In the present analysis, all MRIs were re-evaluated by 2 blinded central readers in a consensus read fashion for a priori defined MRI parameters based on HEMRIS.

resultsAt screening, 171/204 (83.8%) of patients presented with entheseal inflammation and/or structural damage, considering both the Achilles tendon and plantar fascia. Pathologies were more evident in the Achilles tendon area compared to the plantar aponeurosis. The most frequent pathologies were intra-tendon hypersignal and retrocalcaneal bursitis. The mean total entheseal inflammation score at screening in the Achilles tendon area was 2.99 (N=204) and the mean change (standard deviation [SD]) from screening to weeks 24 and 52 was - 0.91 (1.99) and - 0.83 (2.12) in the secukinumab group vs - 0.48 (1.86) and - 0.80 (1.98) in the placebo-secukinumab group, respectively. The mean total structural damage score at screening was 1.36 (N=204) and the mean change (SD) from screening to weeks 24 and 52 was 0.00 (0.65) and - 0.06 (0.56) in the secukinumab group vs 0.08 (0.48) and 0.04 (0.75) in the placebo-secukinumab group, respectively.

conclusionsBased on the newly developed HEMRIS, entheseal inflammation and/or structural damage was confirmed in 83.3% of ACHILLES patients. Pathologies were more evident in the Achilles tendon area compared to plantar fascia, with the inflammatory parameters being more responsive with secukinumab treatment compared to placebo. The present analysis, with detailed information on individual MRI parameters, contributes to the scientific debate on heel enthesitis.

trial registrationClinicalTrials.gov NCT02771210 .

Indexed as

Achilles TendonEnthesopathySpondylarthritisHeelHumansInflammationMagnetic Resonance ImagingEnthesitisHeelHEMRISInflammationMRI scoring systemSpondyloarthritisStructural damage

Identifiers

PMID35578245
PMCPMC9109380
OpenAlexW4280559402

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.