Evidence map›Paper›PMID 37194094›Full record

Trial reportArthritis research & therapy2023

Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis.

Juergen Braun, Ricardo Blanco, Helena Marzo-Ortega, Lianne S Gensler, Filip Van den Bosch, Stephen Hall, Hideto Kameda, Denis Poddubnyy, Marleen van de Sande, Désirée van der Heijde and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02696031 (A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.7field-weighted citation impact, top 5% 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.

NCT02696031 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2021Enrolled555ConditionsNon-radiographic SpondyloarthritisArmsSecukinumab, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  3. The 60Rheumatology and immunology research · 2026
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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

15 authors at 14 institutions in 11 countries.

Juergen BraunDepartment of Rheumatology, Ruhr-University Bochum, Bochum, Germany. juebraun@gmx.de.
Ricardo BlancoDivision of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, LIRMM, University of Leeds, Leeds, UK.
Lianne S GenslerUniversity of California, San Francisco, San Francisco, CA, USA.
Filip Van den BoschDepartment of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Stephen HallDepartment of Medicine, Monash University, Melbourne, Australia.
Hideto KamedaToho University, Tokyo, Japan.
Denis PoddubnyyGerman Rheumatism Research Centre, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Marleen van de SandeAmsterdam Rheumatology and Immunology Center, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands.
Tingting ZhuangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Anna StefanskaNovartis Ireland Limited, Dublin, Ireland.
Aimee ReadieNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Hanno B RichardsNovartis Pharma AG, Basel, Switzerland.
Atul DeodharOregon Health & Science University, Division of Arthritis and Rheumatic Diseases, Portland, USA.
Novartis (United States) · USCharité - Universitätsmedizin Berlin · DEGhent University Hospital · BEInstituto de Investigación Marqués de Valdecilla · ESLeiden University Medical Center · NLMonash University · AUNovartis (Ireland) · IENovartis (Switzerland) · CHOregon Health & Science University · USRuhr University Bochum · DEToho University · JPUniversity of Amsterdam · NLUniversity of California, San Francisco · USUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadiographic progression and course of inflammation over 2 years in patients with non-radiographic axial spondyloarthritis (nr-axSpA) from the phase 3, randomized, PREVENT study are reported here.

methodsIn the PREVENT study, adult patients fulfilling the Assessment of SpondyloArthritis International Society classification criteria for nr-axSpA with elevated CRP and/or MRI inflammation received secukinumab 150 mg or placebo. All patients received open-label secukinumab from week 52 onward. Sacroiliac (SI) joint and spinal radiographs were scored using the modified New York (mNY) grading (total sacroiliitis score; range, 0-8) and modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range, 0-72), respectively. SI joint bone marrow edema (BME) was assessed using the Berlin Active Inflammatory Lesions Scoring (0-24) and spinal MRI using the Berlin modification of the AS spine MRI (ASspiMRI) scoring (0-69).

resultsOverall, 78.9% (438/555) of patients completed week 104 of the study. Over 2 years, minimal changes were observed in total radiographic SI joint scores (mean [SD] change, - 0.04 [0.49] and 0.04 [0.36]) and mSASSS scores (0.04 [0.47] and 0.07 [0.36]) in the secukinumab and placebo-secukinumab groups. Most of the patients showed no structural progression (increase ≤ smallest detectable change) in SI joint score (87.7% and 85.6%) and mSASSS score (97.5% and 97.1%) in the secukinumab and placebo-secukinumab groups. Only 3.3% (n = 7) and 2.9% (n = 3) of patients in the secukinumab and placebo-secukinumab groups, respectively, who were mNY-negative at baseline were scored as mNY-positive at week 104. Overall, 1.7% and 3.4% of patients with no syndesmophytes at baseline in the secukinumab and placebo-secukinumab group, respectively, developed ≥ 1 new syndesmophyte over 2 years. Reduction in SI joint BME observed at week 16 with secukinumab (mean [SD], - 1.23 [2.81] vs - 0.37 [1.90] with placebo) was sustained through week 104 (- 1.73 [3.49]). Spinal inflammation on MRI was low at baseline (mean score, 0.82 and 1.07 in the secukinumab and placebo groups, respectively) and remained low (mean score, 0.56 at week 104).

conclusionStructural damage was low at baseline and most patients showed no radiographic progression in SI joints and spine over 2 years in the secukinumab and placebo-secukinumab groups. Secukinumab reduced SI joint inflammation, which was sustained over 2 years.

trial registrationClinicalTrials.gov, NCT02696031.

Indexed as

Non-Radiographic Axial SpondyloarthritisSacroiliitisSpondylarthritisSpondylitis, AnkylosingAdultAntibodies, Monoclonal, HumanizedHumansInflammationMagnetic Resonance ImagingSacroiliac JointAntibodies, Monoclonal, HumanizedsecukinumabAxial spondyloarthritisImagingNon-radiographic axial spondyloarthritisNr-axSpARadiographSecukinumabX-ray

Identifiers

PMID37194094
PMCPMC10186767
OpenAlexW4376873015

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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.