Evidence map›Paper›PMID 24035250›Full record

Trial reportLancet (London, England)2013

Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial.

Dominique Baeten, Xenofon Baraliakos, Jürgen Braun, Joachim Sieper, Paul Emery, Désirée van der Heijde, Iain McInnes, Jacob M van Laar, Robert Landewé, Paul Wordsworth and 13 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00809159 (Randomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis), which is not on this map. Cited by 267 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
267citing papers in PubMed, 18 pooled it
56.0field-weighted citation impact, top 1% 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.

NCT00809159 phase2completednot on this map

Randomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2011Enrolled60ConditionsAnkylosing SpondylitisArmsAIN457, Placebo
3 · Its place in the literature

Who cites it

267 citing papers in PubMed, 18 syntheses or guidelines pooled it, 586 citations in OpenAlex.

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207 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 15 institutions in 6 countries.

Dominique BaetenDepartment of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
Xenofon Baraliakos
Jürgen Braun
Joachim Sieper
Paul Emery
Désirée van der Heijde
Iain McInnes
Jacob M van Laar
Robert Landewé
Paul Wordsworth
Jürgen Wollenhaupt
Herbert Kellner
Jacqueline Paramarta
Jiawei Wei
Arndt Brachat
Stephan Bek
Didier Laurent
Yali Li
Ying A Wang
Arthur P Bertolino
Sandro Gsteiger
Andrew M Wright
Wolfgang Hueber
Novartis (Switzerland) · CHNovartis (United States) · USRheumazentrum Ruhrgebiet · DEAcademic Medical Center · NLAtrium Medisch Centrum Parkstad · NLCharité - Universitätsmedizin Berlin · DELeeds Teaching Hospitals NHS Trust · GBLeiden University Medical Center · NLNational Institute for Health Research · GBNewcastle University · GBNovartis (China) · CNNovartis Institutes for BioMedical ResearchSchön Klinik Hamburg Eilbek · DEUniversity of Amsterdam · NLUniversity of Glasgow · GB

Funding

Arthritis Research UK 18475Versus Arthritis 19356
6 · The paper itself

Abstract

backgroundAnkylosing spondylitis is a chronic immune-mediated inflammatory disease characterised by spinal inflammation, progressive spinal rigidity, and peripheral arthritis. Interleukin 17 (IL-17) is thought to be a key inflammatory cytokine in the development of ankylosing spondylitis, the prototypical form of spondyloarthritis. We assessed the efficacy and safety of the anti-IL-17A monoclonal antibody secukinumab in treating patients with active ankylosing spondylitis.

methodsWe did a randomised double-blind proof-of-concept study at eight centres in Europe (four in Germany, two in the Netherlands, and two in the UK). Patients aged 18-65 years were randomly assigned (in a 4:1 ratio) to either intravenous secukinumab (2×10 mg/kg) or placebo, given 3 weeks apart. Randomisation was done with a computer-generated block randomisation list without a stratification process. The primary efficacy endpoint was the percentage of patients with a 20% response according to the Assessment of SpondyloArthritis international Society criteria for improvement (ASAS20) at week 6 (Bayesian analysis). Safety was assessed up to week 28. This study is registered with ClinicalTrials.gov, number NCT00809159.

findings37 patients with moderate-to-severe ankylosing spondylitis were screened, and 30 were randomly assigned to receive either intravenous secukinumab (n=24) or placebo (n=6). The final efficacy analysis included 23 patients receiving secukinumab and six patients receiving placebo, and the safety analysis included all 30 patients. At week 6, ASAS20 response estimates were 59% on secukinumab versus 24% on placebo (99·8% probability that secukinumab is superior to placebo). One serious adverse event (subcutaneous abscess caused by Staphylococcus aureus) occurred in the secukinumab-treated group.

interpretationSecukinumab rapidly reduced clinical or biological signs of active ankylosing spondylitis and was well tolerated. It is the first targeted therapy that we know of that is an alternative to tumour necrosis factor inhibition to reach its primary endpoint in a phase 2 trial.

fundingNovartis.

Indexed as

AbscessAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkersDouble-Blind MethodFemaleHumansInfusions, IntravenousMagnetic Resonance ImagingMaleMiddle AgedSpondylitis, AnkylosingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiomarkerssecukinumab

Identifiers

PMID24035250
OpenAlexW2118706017

What OpenQuestion holds

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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.