Evidence map›Paper›PMID 34528079›Full record

Trial reportRheumatology (Oxford, England)2022

Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE.

Maria Antonietta D'Agostino, Georg Schett, Alejandra López-Rdz, Ladislav Šenolt, Katalin Fazekas, Ruben Burgos-Vargas, Jose Maldonado-Cocco, Esperanza Naredo, Philippe Carron, Anne-Marie Duggan and 3 more

Registry-linked trialOpen access · bronzeAbstract 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 NCT02662985 (A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT02662985 phase3completednot on this map

A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2020Enrolled166ConditionsPsoriatic ArthritisArmsAIN457 (secukinumab), Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Imaging in psoriatic arthritis: established methods and emerging techniques.Therapeutic advances in musculoskeletal disease · 2024
    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

13 authors at 12 institutions in 12 countries.

Maria Antonietta D'AgostinoDepartment of Rheumatology, Catholic University of Sacred Heart, Roma, Italy.ORCID 0000-0002-5347-0060
Georg SchettDepartment of Internal Medicine 3.
Alejandra López-RdzDermatológico Country, PSOAPS Psoriasis Clinical and Research Centre, Guadalajara, Mexico.
Ladislav ŠenoltInstitute of Rheumatology and Department of Rheumatology, Charles University, Prague, Czech Republic.
Katalin FazekasDepartment of Rheumatology, Miskolci Semmelweis Hospital and University Teaching Hospital, Miskolci, Hungary.
Ruben Burgos-VargasDepartment of Rheumatology, Hospital General de Mexico, Mexico City, Mexico.
Jose Maldonado-CoccoSchool of Medicine, University of Buenos Aires, Buenos Aires, Argentina.
Esperanza NaredoDepartment of Rheumatology and Joint and Bone Research Unit, Hospital Fundación Jiménez Díaz and Autónoma University, Madrid, Spain.
Philippe CarronDepartment of Rheumatology, Ghent University Hospital.
Anne-Marie DugganNovartis Ireland Limited, Dublin, Ireland.
Punit GoyankaNovartis Healthcare Pvt Ltd, Hyderabad, India.
Maarten BoersDepartment of Epidemiology and Data Science, and Amsterdam Rheumatology and Immunology Centre, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.ORCID 0000-0002-6969-283X
Corine GaillezNovartis Pharma AG, Basel, Switzerland.
Amsterdam University Medical Centers · NLCharles University · CZFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGhent University Hospital · BEHospital General de México · MXHospital Universitario Fundación Jiménez Díaz · ESNovartis (India) · INNovartis (Ireland) · IENovartis (Switzerland) · CHUniversidad de Buenos Aires · ARUniversità Cattolica del Sacro Cuore · ITUniversity of Miskolc · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound.

methodsThe randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses.

resultsOf the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported.

conclusionThis unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients.

trial registrationClinicalTrials.gov; NCT02662985.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticSynovitisAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansInterleukin-17Treatment OutcomeUltrasonography, DopplerAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsInterleukin-17secukinumabbiological DMARDsclinical outcomeGLOESSjointsOMERACTPower Doppler ultrasoundPsAresponsivenesssecukinumabsynovitis

Identifiers

PMID34528079
PMCPMC9071547
OpenAlexW3201629844

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.