Evidence map›Paper›PMID 30564451›Full record

ArticleRMD open2018

Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies.

Jürgen Braun, Atul Deodhar, Robert Landewé, Xenofon Baraliakos, Corinne Miceli-Richard, Joachim Sieper, Erhard Quebe-Fehling, Ruvie Martin, Brian Porter, Kunal K Gandhi and 2 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in RMD open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
4.0field-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.

NCT01358175 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2014Enrolled371ConditionsAnkylosing SpondylitisArmsSecukinumab (75 mg), Secukinumab (150 mg), Placebo
NCT01649375 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2018Enrolled219ConditionsAnklyosing SpondylitisArmsSecukinumab (75 mg), Placebo, Secukinumab (150 mg)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 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

12 authors at 8 institutions in 5 countries.

Jürgen BraunRheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
Atul DeodharOregon Health & Science University, Portland, Oregon, USA.
Robert LandewéUniversity of Amsterdam and Atrium Medical Centre, Amsterdam, The Netherlands.
Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
Corinne Miceli-RichardParis Descartes University, Department of Rheumatology -Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France.
Joachim SieperCharité University Medicine Berlin, Berlin, Germany.
Erhard Quebe-FehlingNovartis Pharma AG, Basel, Switzerland.
Ruvie MartinNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Brian PorterNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Kunal K GandhiNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Désirée van der HeijdeLeiden University Medical Centre, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
MEASURE 1 and MEASURE 2 study groups
Novartis (United States) · USRheumazentrum Ruhrgebiet · DECharité - Universitätsmedizin Berlin · DELeiden University Medical Center · NLNovartis (Switzerland) · CHOregon Health & Science University · USUniversité Paris Cité · FRUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375).

methodsThis post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150  mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5  mg/L (normal) or ≥5  mg/L (elevated) and a cut-off <10  mg/L or ≥10  mg/L.

resultsAt baseline, 36.5% (143/392) patients had normal and 63.5% (249/392) had elevated CRP. At week 16, ASAS20/40 response rates were higher for secukinumab versus placebo in normal (56.9%/34.7% vs 28.2%/7.0%; p<0.01/p<0.001) and in elevated (63.2%/42.4% vs 29.0%/15.3%; both p<0.0001) CRP groups. Improvement was reported for all outcomes (p<0.05) in both groups, except for ASAS partial remission in the normal CRP group, where a numerical difference 12.5% vs 2.8%, p=0.07) was observed. Similar trends of improvement were observed in the <10  and ≥10  mg/L groups across all efficacy outcomes at week 16. Treatment responses to secukinumab in all CRP groups further improved over 156 weeks.

conclusionSecukinumab 150  mg demonstrated rapid and sustained efficacy in patients with AS irrespective of baseline CRP, with greater magnitude of response in patients with more elevated CRP.

Indexed as

ankylosing spondylitiscytokineDMARDs (biologic)inflammationspondyloarthritis

Identifiers

PMID30564451
PMCPMC6269637
OpenAlexW2900801709

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.