Evidence map›Paper›PMID 35188180›Full record

Trial reportRheumatology (Oxford, England)2022

Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging.

Walter P Maksymowych, Rebecca Bolce, Gaia Gallo, Emily Seem, Vladimir J Geneus, David M Sandoval, Mikkel Østergaard, Kurisu Tada, Xenofon Baraliakos, Atul Deodhar and 1 more

2 registry-linked trialsOpen access · greenAbstract readRandomized 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 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

NCT02696785 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2018Enrolled341ConditionsSpondyloarthritisArmsIxekizumab, Placebo, Adalimumab
NCT02696798 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2019Enrolled316ConditionsSpondyloarthritisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. Article
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  7. Review
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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

11 authors at 7 institutions in 5 countries.

Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-1291-1755
Rebecca BolceEli Lilly and Company, Indianapolis, IN, USA.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Emily SeemEli Lilly and Company, Indianapolis, IN, USA.
Vladimir J GeneusEli Lilly and Company, Indianapolis, IN, USA.
David M SandovalEli Lilly and Company, Indianapolis, IN, USA.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet.ORCID 0000-0003-3690-467X
Kurisu TadaDepartment of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
Xenofon BaraliakosRuhr-University Bochum, Bochum.ORCID 0000-0002-9475-9362
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.
Lianne S GenslerDepartment of Medicine, Division of Rheumatology, University of California, San Francisco, School of Medicine, San Francisco, CA, USA.
Eli Lilly (United States) · USJuntendo University · JPOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEUniversity of Alberta · CAUniversity of California, San Francisco · USUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate response rates at week 16 with ixekizumab in patients with radiographic axial SpA (r-axSpA) and elevated or normal/low baseline inflammation measured by serum CRP or spinal MRI using data from two randomized, double-blind, placebo (PBO)-controlled phase III trials.

methodsBiologic-naïve (COAST-V) or TNF inhibitor-experienced (COAST-W) adults with active r-axSpA received 80 mg ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W) or PBO or active reference [40 mg adalimumab every 2 weeks (ADAQ2W) in COAST-V. At week 16, patients receiving ixekizumab continued as assigned and patients receiving PBO or ADA were rerandomized 1:1 to IXEQ2W or IXEQ4W through week 52. Assessment of SpondyloArthritis international Society 40% (ASAS40) response rates were examined by baseline CRP (≤5 or >5 mg/l) and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine inflammation score (<2 or ≥2).

resultsIn the COAST-V/W integrated dataset (N = 567), significantly more patients treated with ixekizumab achieved ASAS40 response at week 16 by CRP ≤5 mg/l (27% IXEQ4W, P < 0.05; 35% IXEQ2W, P < 0.01 vs 12% PBO), CRP >5 mg/l (39% IXEQ4W, P < 0.001; 43% IXEQ2W, P < 0.001 vs 17% PBO), SPARCC MRI spine score <2 (40% IXEQ4W P < 0.01, 52% IXEQ2W P < 0.001 vs 16% PBO), and SPARCC MRI spine score ≥2 (44% IXEQ4W P < 0.001, 47% IXEQ2W P < 0.001 vs 19% PBO). ASAS40 response was observed with CRP ≤5 mg/l and SPARCC MRI spine score <2 with IXEQ4W (29%) and was significant with IXEQ2W (48%; P < 0.05) vs PBO (13%).

conclusionIxekizumab demonstrated efficacy in the treatment of AS/r-axSpA in patients with and without elevated CRP or evidence of spinal inflammation on MRI.

trial registrationClinicalTrials.gov (https://clinicaltrials.gov): NCT02696785, NCT02696798.

Indexed as

Antirheumatic AgentsAxial SpondyloarthritisSpondylarthritisAdultAntibodies, Monoclonal, HumanizedC-Reactive ProteinDouble-Blind MethodHumansInflammationMagnetic Resonance ImagingTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsC-Reactive ProteinixekizumabASCRPinflammationixekizumabMRIrandomized clinical trials

Identifiers

PMID35188180
PMCPMC9629340
OpenAlexW4212816050

What OpenQuestion holds

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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.