Evidence map›Paper›PMID 33220702›Full record

Trial reportBMC musculoskeletal disorders2020

Achilles tendon enthesitis evaluated by MRI assessments in patients with axial spondyloarthritis and psoriatic arthritis: a report of the methodology of the ACHILLES trial.

Xenofon Baraliakos, Philipp Sewerin, Eugenio de Miguel, Effie Pournara, Christine Kleinmond, Annette Wiedon, Frank Behrens

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2020. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.8field-weighted citation impact, top 8% 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

8 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence.Therapeutic advances in musculoskeletal disease · 2021
    Review
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

7 authors at 6 institutions in 3 countries.

Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, 44649, Herne, Germany. xenofon.baraliakos@elisabethgruppe.de.
Philipp SewerinDepartment and Hiller Research Unit of Rheumatology, University Hospital Düsseldorf, Düsseldorf, Germany.
Eugenio de MiguelDepartment of Rheumatology, University Hospital La Paz, Madrid, Spain.
Effie PournaraNovartis Pharma AG, Basel, Switzerland.
Christine KleinmondClinProject GmbH, Eurasburg, Germany.
Annette WiedonNovartis Pharma GmbH, Nürnberg, Germany.
Frank BehrensCIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.
Düsseldorf University Hospital · DEGoethe University Frankfurt · DEHospital Universitario La Paz · ESNovartis (Germany) · DENovartis (Switzerland) · CHRheumazentrum Ruhrgebiet · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe currently available scoring methods for enthesitis are often measures of pain but not of inflammation at entheseal sites. The Outcome Measures in Rheumatology Clinical Trials (OMERACT) psoriatic arthritis (PsA) magnetic resonance imaging (MRI) scoring system (PsAMRIS) assesses inflammation and damage in PsA and was particularly developed for the hands. The ACHILLES trial used clinical measures for heel enthesitis in combination with MRI scoring based on PsAMRIS.

methodsPatients (age ≥ 18 years) with spondyloarthritis (SpA) and PsA were included in the trial if they presented with clinical and MRI-positive heel enthesitis. MRI of the affected heel was performed at three time points: screening, Week 24 and Week 52. Inflammatory MRI findings (tendinitis, bursitis and bone marrow oedema [BME]) in the area of the Achilles tendon and/or plantar aponeurosis, periarticular inflammation of the ankle joint and heel erosion were assessed qualitatively (absent/present). In addition, BME and bone erosion were quantitatively assessed based on PsAMRIS, where their proportion was compared to the volume of the affected bone. Mean scores of BME and bone erosion quantification were calculated, and the mean composite score (based on PsAMRIS) was calculated based on the individual score of each subject for periarticular inflammation, BME and bone erosion and further extended for bursitis and tendinitis. Modifications to PsAMRIS were introduced by categorising oedema length as ≤/> 0.5 cm and locating bone erosion.

conclusionsIn ACHILLES, MRI was used to assess and evaluate heel enthesitis. Due to the lack of a validated scoring system for heel enthesitis at the time of ACHILLES initiation, this trial applied quantitative scoring based on PsAMRIS, with specific adaptations for the heel.

trial registrationNational Clinical Trial Registry, NCT02771210 . Registered 13 May 2016.

Indexed as

Achilles TendonArthritis, PsoriaticEnthesopathySpondylarthritisAdultHumansMagnetic Resonance ImagingAchilles tendonBone erosionBone oedemaEnthesitisMRIPsAMRISSpondyloarthritis

Identifiers

PMID33220702
PMCPMC7680600
OpenAlexW3108485351

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.