Evidence map›Paper›PMID 35853675›Full record

ArticleRMD open2022

Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST.

Jürgen Braun, Uta Kiltz, Atul Deodhar, Tetsuya Tomita, Maxime Dougados, Rebecca Bolce, David Sandoval, Chen-Yen Lin, Jessica Walsh

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03129100 (A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

NCT03129100 phase3completednot on this map

A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2021Enrolled773ConditionsAxial SpondyloarthritisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 17 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

9 authors at 6 institutions in 4 countries.

Jürgen BraunRheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universität, Bochum, Germany juergen.braun@elisabethgruppe.de.ORCID 0000-0002-9156-5095
Uta KiltzRheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universität, Bochum, Germany.ORCID 0000-0001-5668-4497
Atul DeodharDivision of Arthritis and Rheumatic Diseases, School of Medicine, Oregon Health & Science University, Portland, Oregon, USA.
Tetsuya TomitaDepartment of Orthopaedic Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Maxime DougadosDepartment of Rheumatology, Hopital Cochin, Paris, France.ORCID 0000-0003-3009-6229
Rebecca BolceEli Lilly and Company, Indianapolis, Indiana, USA.
David SandovalEli Lilly and Company, Indianapolis, Indiana, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, Indiana, USA.
Jessica WalshDivision of Rheumatology, University of Utah, Salt Lake City, Utah, USA.
Eli Lilly (United States) · USRheumazentrum Ruhrgebiet · DEHôpital Cochin · FROregon Health & Science University · USThe University of Osaka · JPUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo study the efficacy and safety of ixekizumab (IXE) in patients with radiographic (r-) and non-radiographic (nr-)axial spondyloarthritis (axSpA) for up to 116 weeks.

methodsCOAST-Y (NCT03129100) is the 2-year extension study following COAST-V, COAST-W and COAST-X. Patients were treated with either 80 mg IXE every 4 weeks or 2 weeks, as assigned in the originating studies. Efficacy was assessed in all participants continuously treated with IXE through week 116 and in subgroups based on disease subtype and dosing. Missing data were handled by non-responder imputation for categorical variables and modified baseline observation carried forward for continuous variables. Safety data were analysed in all patients having received ≥1 IXE dose.

resultsOf 932 patients who received ≥1 IXE dose, 773 enrolled in COAST-Y (82.9%); 665 of which (86.0%) completed week 116. Of 352 continuously treated patients, the proportion achieving Assessment of Spondyloarthritis International Society (ASAS40) at week 52 was 51.4%, which increased to 56.0% at week 116. The proportion of patients achieving ASAS40 at week 116 was 64.9% and 57.7% for biological disease-modifying antirheumatic drug (bDMARD)-naïve patients with r-axSpA and nr-axSpA, respectively, and 47.0% for TNFi-experienced patients. The proportion of patients achieving Ankylosing Spondylitis Disease Activity Score <2.1 through week 116 was 57.0% and 52.9% for bDMARD-naïve patients with r-axSpA and nr-axSpA, respectively, and 33.6% for TNFi-experienced patients. Incidences of treatment-emergent adverse events and serious adverse events were consistent with previous reports.

conclusionIXE treatment led to sustained long-term improvements in patients with axSpA, with similar efficacy for r-axSpA and nr-axSpA, and for patients receiving the approved every 4 weeks dose. The safety profile of IXE was consistent with previous reports. No new safety signals were identified.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsAxial SpondyloarthritisHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsixekizumabAntirheumatic AgentsBiological TherapyPatient Reported Outcome MeasuresSpondylitis, Ankylosing

Identifiers

PMID35853675
PMCPMC9301795
OpenAlexW4286255926

What OpenQuestion holds

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LicenceCC BY-NC
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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.