Evidence map›Paper›PMID 33044756›Full record

Trial reportArthritis care & research2022

Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial.

Jessica A Walsh, Marina N Magrey, Xenofon Baraliakos, Kentaro Inui, Meng-Yu Weng, Ennio Lubrano, Désirée van der Heijde, Annelies Boonen, Lianne S Gensler, Vibeke Strand and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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  4. Review
  5. Article
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

17 authors at 10 institutions in 6 countries.

Jessica A WalshUniversity of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.ORCID 0000-0002-4563-0845
Marina N MagreyMetroHealth Medical Center and Case Western Reserve University School of Medicine, Cleveland, Ohio.
Xenofon BaraliakosRuhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.
Kentaro InuiOsaka City University Graduate School of Medicine, Osaka, Japan.
Meng-Yu WengNational Cheng Kung University Medical College and Hospital, Tainan, Taiwan.
Ennio LubranoUniversity of Molise, Campobasso, Italy.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands.
Annelies BoonenMaastricht University Medical Center and Caphri Research Institute, Maastricht University, Maastricht, The Netherlands.
Lianne S GenslerUniversity of California, San Francisco.
Vibeke StrandStanford University School of Medicine, Palo Alto, California.
Jürgen BraunRuhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.
Theresa HunterEli Lilly and Company, Indianapolis, Indiana.ORCID 0000-0001-8412-9175
Xiaoqi LiEli Lilly and Company, Indianapolis, Indiana.
Baojin ZhuEli Lilly and Company, Indianapolis, Indiana.
Luis LeónEli Lilly and Company, Indianapolis, Indiana.
David Marcelino Sandoval CalderonEli Lilly and Company, Indianapolis, Indiana.
Uta KiltzRuhr-University Bochum, Bochum, Germany, and Osaka City University Graduate School of Medicine, Osaka, Japan.ORCID 0000-0001-5668-4497
Eli Lilly (United States) · USOsaka City University · JPLeiden University Medical Center · NLMaastricht University Medical Centre · NLMetroHealth Medical Center · USNational Cheng Kung University Hospital · TWPalo Alto University · USUniversity of California, San Francisco · USUniversity of Molise · ITUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA).

methodsCOAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system.

resultsCompared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported ≥3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in "good health status" on the ASAS health index (ASAS score of ≤5) at weeks 16 and 52 (P < 0.05). Patients receiving ixekizumab reported improvements on the EQ-5D-5L compared to those who received placebo at week 16 (0.11 versus 0.17 for patients receiving treatment every 4 weeks and 0.19 for patients receiving treatment every 2 weeks; P < 0.05), which remained consistent at week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen for patients who received ixekizumab therapy every 2 weeks or every 4 weeks.

conclusionIn patients with nonradiographic axial SpA, therapy with ixekizumab was superior to placebo in the improvement of self-reported functioning and health at weeks 16 and 52.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedNon-Radiographic Axial SpondyloarthritisQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic Agentsixekizumab

Identifiers

PMID33044756
PMCPMC9306696
OpenAlexW3092616577

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.