Evidence map›Paper›PMID 38637464›Full record

ArticleRheumatology and therapy2024

Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial.

Kurt de Vlam, Walter P Maksymowych, Gaia Gallo, Proton Rahman, Philip Mease, Venkatesh Krishnan, Conor J McVeigh, Jeffrey Lisse, Danting Zhu, Rebecca J Bolce and 1 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. 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 NCT02696785 (A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.8field-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.

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
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Towards an individualised approach to pain management in inflammatory arthritis.Therapeutic advances in musculoskeletal disease · 2026
    Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 4 countries.

Kurt de VlamUniversity Hospital Leuven, Leuven, Belgium. kurt.devlam@uzleuven.be.
Walter P MaksymowychDepartment of Medicine, Division of Rheumatology at the University of Alberta, Edmonton, Alberta, Canada.
Gaia GalloEli Lilly and Company, Indianapolis, USA.
Proton RahmanDepartment of Medicine, Memorial University, St. John's, Newfoundland, A1C 5B8, Canada.
Philip MeaseSwedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, Washington, USA.
Venkatesh KrishnanEli Lilly and Company, Indianapolis, USA.
Conor J McVeighEli Lilly and Company, Indianapolis, USA.
Jeffrey LisseEli Lilly and Company, Indianapolis, USA.
Danting ZhuEli Lilly and Company, Indianapolis, USA.
Rebecca J BolceEli Lilly and Company, Indianapolis, USA.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK.
Eli Lilly (United States) · USKU Leuven · BEMemorial University of Newfoundland · CANIHR Leeds Musculoskeletal Biomedical Research Unit · GBSwedish Medical Center · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe objective of this analysis is to evaluate the improvement in spinal pain with ixekizumab, placebo, and adalimumab based on objective measures of inflammation response in patients with ankylosing spondylitis (AS).

methodsThe COAST-V 52-week, double-blind, placebo-controlled, randomized phase III trial examined the efficacy of ixekizumab in patients with active AS; adalimumab was used as an active reference arm. Treatment effects on reduction in pain were assessed by objective measures of controlled and persisting inflammation (defined by magnetic resonance imaging [MRI], C-reactive protein [CRP], or MRI + CRP status). Pathway analysis was used to analyze treatment effect that was not attributable to reduction in inflammation biomarkers.

resultsIn patients with AS, when inflammation was controlled as assessed by MRI, patients treated with ixekizumab experienced a reduction in spinal pain at night (SP-N, numeric rating scale, ixekizumab mean = - 3.9, p < 0.001, adalimumab mean = - 2.6, p < 0.05) compared to placebo (mean =  - 1.6) at week 16. When inflammation was controlled as assessed by MRI + CRP, ixekizumab and adalimumab had numerically greater reductions at week 16 in SP-N versus placebo. All ixekizumab groups had further improvements at week 52. When inflammation was persisting as assessed by MRI + CRP, ixekizumab-treated patients had significant reduction in SP-N (mean = - 3.7, p < 0.001) versus placebo (mean = - 1.7), improvement with adalimumab did not reach significance (mean = - 2.6, p = 0.06). In the pathway analysis at week 16, ixekizumab had a greater effect on pain outcomes compared to adalimumab.

conclusionThis post hoc analysis is supportive of the hypothesis that ixekizumab reduces pain in AS by additional mechanisms other than the reduction of measurable inflammation. TRIAL REGISTRATION NUMBER: NCT02696785.

Indexed as

IL-17InflammationPainRheumatic diseaseSpondylitis, ankylosing

Identifiers

PMID38637464
PMCPMC11111437
OpenAlexW4394911994

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.