Evidence map›Paper›PMID 34481517›Full record

Trial reportArthritis research & therapy2021

Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT.

Jürgen Braun, Ricardo Blanco, Helena Marzo-Ortega, Lianne S Gensler, Filip van den Bosch, Stephen Hall, Hideto Kameda, Denis Poddubnyy, Marleen van de Sande, Anna S Wiksten and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2021. 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 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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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 12 institutions in 9 countries.

Jürgen BraunRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany. juergen.braun@elisabethgruppe.de.ORCID 0000-0002-9156-5095
Ricardo BlancoIDIVAL, Hospital University Marqués de Valdecilla, Santander, Spain.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, Leeds, UK.
Lianne S GenslerDepartment of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA.
Filip van den BoschDepartment of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.
Stephen HallMonash University, Melbourne, Australia.
Hideto KamedaToho University, Tokyo, Japan.
Denis PoddubnyyCharité Universitätsmedizin, Berlin, Germany.
Marleen van de SandeDepartment of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam, The Netherlands.
Anna S WikstenNovartis Pharma AG, Basel, Switzerland.
Brian O PorterNovartis Pharmaceuticals Corporation, East Hanover, USA.
Abhijit SheteNovartis Pharma AG, Basel, Switzerland.
Hanno B RichardsNovartis Pharma AG, Basel, Switzerland.
Sibylle HaemmerleNovartis Pharma AG, Basel, Switzerland.
Atul DeodharOregon Health & Science University, Portland, USA.
Novartis (Switzerland) · CHAmsterdam University Medical Centers · NLCharité - Universitätsmedizin Berlin · DEGhent University · BEInstituto de Investigación Marqués de Valdecilla · ESMonash University · AUNovartis (United States) · USOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEToho University · JPUniversity of California, San Francisco · USUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex.

methodsThe phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex.

resultsEfficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27- subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively.

conclusionsSecukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/-) and/or MRI (+/-) status, HLA-B27 (+/-) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (-) subgroups. Male patients had higher relative responses than female patients.

trial registrationClinicalTrials.gov , NCT02696031 . Registered on 02 March 2016.

Indexed as

SpondylarthritisSpondylitis, AnkylosingAntibodies, Monoclonal, HumanizedFemaleHLA-B27 AntigenHumansMaleTreatment OutcomeAntibodies, Monoclonal, HumanizedHLA-B27 AntigensecukinumabBiologicalsC-reactive proteinGenderHuman leukocyte antigen B27InterleukinsMagnetic resonance imagingNon-radiographic axial spondyloarthritis

Identifiers

PMID34481517
PMCPMC8418044
OpenAlexW3196594418

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.