Evidence map›Paper›PMID 34730795›Full record

Trial reportRheumatology (Oxford, England)2022

Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial.

Frank Behrens, Philipp Sewerin, Eugenio de Miguel, Yusuf Patel, Anastas Batalov, Eva Dokoupilova, Christine Kleinmond, Effie Pournara, Ankita Shekhawat, Claudia Jentzsch and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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

15 citing papers in PubMed.

  1. Trial
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  4. Review
  5. Review
  6. CD4iScience · 2026
    Article
  7. Review
  8. Article
  9. Article
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  11. Review
  12. Review
  13. Article
  14. Observational
  15. Secukinumab might improve enthesitis in SpA.Nature reviews. Rheumatology · 2022
    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

13 authors.

Frank BehrensCIRI/Rheumatology and Fraunhofer Institute for Translationale Medicine & Pharmacology (ITMP) and Cluster of Excellence Immune-Mediated Diseases (CIMD), Goethe-University, Frankfurt.ORCID 0000-0001-8750-7186
Philipp SewerinDepartment of Rheumatology & Hiller Research Unit, University Hospital Duesseldorf, Duesseldorf, Germany.ORCID 0000-0001-8465-6207
Eugenio de MiguelRheumatology Department, Hospital Universitario La Paz, Madrid, Spain.ORCID 0000-0001-5146-1964
Yusuf PatelHull University Teaching Hospitals, Hull, UK.
Anastas BatalovMedical University of Plovdiv, University Hospital Kaspela, Plovdiv, Bulgaria.ORCID 0000-0001-8857-0574
Eva DokoupilovaFaculty of Pharmacy, Department of Pharmaceutical Technology, Medical Plus, s.r.o., Uherske Hradiste; Masaryk University, Brno, Czech Republic.
Christine KleinmondClinProject GmbH, Eurasburg, Germany.
Effie PournaraNovartis Pharma AG, Basel, Basel-Stadt, Switzerland.
Ankita ShekhawatNovartis Healthcare Pvt. Ltd, Hyderabad, India.
Claudia JentzschNovartis Pharma GmbH, Nürnberg.
Annette WiedonNovartis Pharma GmbH, Nürnberg.
Xenofon BaraliakosRheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany.ORCID 0000-0002-9475-9362
ACHILLES study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveACHILLES aimed to demonstrate efficacy of secukinumab on Achilles' tendon enthesitis in spondyloarthritis (SpA) patients.

methodsPatients ≥18 years (n = 204) with active PsA or axial SpA and heel enthesitis were randomized 1:1 to secukinumab 150/300 mg or placebo up to week 24, and thereafter placebo patients were switched to secukinumab.

resultsAt week 24, a higher, yet statistically non-significant (P = 0.136), proportion of patients in secukinumab vs placebo reported resolution of Achilles tendon enthesitis in affected foot (42.2% vs 31.4%; odds ratio [OR] = 1.63; 95% CI: 0.87, 3.08). Proportion of patients reporting resolution of enthesitis based on Leeds Enthesitis Index was higher with secukinumab vs placebo (33.3% vs 23.5%; OR = 1.65; 95% CI: 0.85, 3.25) at week 24. Mean change from baseline in heel pain at week 24 was higher in secukinumab patients vs placebo (-2.8 [3.0] vs -1.9 [2.7]). Greater improvements with secukinumab were observed in heel enthesopathy activity and global assessment of disease activity. Imaging evaluation by local reading confirmed heel enthesitis on MRI at screening for all patients. Based on central reading, 56% presented with bone marrow oedema and/or tendinitis; according to Heel Enthesitis MRI Scoring System (HEMRIS) post hoc analysis, 76% had signs of entheseal inflammation while 86% had entheseal inflammation and/or structural changes.

conclusionA substantial proportion of patients showed no signs of inflammation on the centrally read MRIs despite a clinical diagnosis of heel enthesitis, thus highlighting that the discrepancy between the clinical and imaging assessments of enthesitis requires further investigation. Although ACHILLES did not meet the primary end point, the study reported clinically meaningful improvements in patient-related outcomes.

trial registrationclinicaltrials.gov, NCT02771210.

Indexed as

Antibodies, Monoclonal, HumanizedEnthesopathySpondylarthritisAchilles TendonAdolescentAdultHumansInflammationAntibodies, Monoclonal, HumanizedsecukinumabAchilles tendon enthesitisbiologicsbone marrow oedemaheel enthesitisIL-17 inhibitorimaging outcomespainspondyloarthritis

Identifiers

PMID34730795
PMCPMC9258542

What OpenQuestion holds

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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.