Evidence map›Paper›PMID 42228347›Full record

ArticleRheumatology and therapy2026

Efficacy of Ixekizumab in Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials.

Raj Sengupta, Pedro M Machado, Philippe Goupille, Martin Rudwaleit, Mohamed Sheesh, Khai Jing Ng, Marcus Ngantcha, Yan Yan, Hagen Russ, Gabriel Doridot and 4 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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
NCT04285229 phase3completednot on this map

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

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2022Enrolled147ConditionsSpondyloarthritisArmsIxekizumab, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Raj SenguptaRheumatology, Royal National Hospital for Rheumatic Diseases NHS, Upper Borough Walls, Bath, BA11RL, UK. rajsen99@gmail.com.ORCID http://orcid.org/0000-0002-9720-0396
Pedro M MachadoDepartment of Neuromuscular Diseases, UCL Queen Square Institute of Neurology, University College London, London, UK.ORCID http://orcid.org/0000-0002-8411-7972
Philippe GoupilleUPR CNRS 4301 CBM, NMNS, University of Tours, Tours, France.ORCID http://orcid.org/0000-0002-8605-1567
Martin RudwaleitDepartment of Internal Medicine and Rheumatology, Medical School and University Medical Center OWL, Klinikum Bielefeld, Bielefeld University, Bielefeld, Germany.ORCID http://orcid.org/0000-0001-5445-548X
Mohamed SheeshEli Lilly and Company, Indianapolis, IN, USA.ORCID http://orcid.org/0009-0008-4430-9399
Khai Jing NgEli Lilly and Company, Indianapolis, IN, USA.
Marcus NgantchaEli Lilly and Company, Indianapolis, IN, USA.
Yan YanEli Lilly and Company, Indianapolis, IN, USA.
Hagen RussEli Lilly and Company, Indianapolis, IN, USA.ORCID http://orcid.org/0009-0006-2743-1398
Gabriel DoridotEli Lilly and Company, Indianapolis, IN, USA.
Yu XueDepartment of Rheumatology, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Denis PoddubnyyDivision of Rheumatology, Department of Medicine, University of Toronto and University Health Network, Toronto, Canada.ORCID http://orcid.org/0000-0002-4537-6015
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany.ORCID http://orcid.org/0000-0002-9475-9362
Victoria Navarro-CompánDepartment of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain.ORCID http://orcid.org/0000-0002-4527-852X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionC-reactive protein (CRP) predicts radiographic progression in radiographic axial spondyloarthritis (r-axSpA). Normal CRP levels have been associated with reduced response to tumor necrosis factor inhibitor treatment. Ixekizumab (IXE) has demonstrated effectiveness in smaller patient groups stratified by CRP at baseline. This pooled analysis aims to demonstrate efficacy stratified by CRP across a broader population.

methodsThis post hoc analysis pooled biologic-naïve patients with r-axSpA from two phase III trials: COAST-V (N = 168) and NCT04285229 (N = 130), with participants receiving IXE 80 mg every 4 weeks or placebo for up to 52 weeks. Analyses evaluated outcomes in patients stratified by CRP at baseline (≤ 5 mg/L or > 5 mg/L). A second analysis subgrouped patients based on magnetic resonance imaging (MRI)-detected inflammation in the spine or sacroiliac joints (SIJ).

resultsBaseline characteristics were comparable between normal (N = 105 [35.2%]) and elevated CRP (N = 193 [64.8%]) groups, except for corticosteroid use, MRI-SPARCC spine and SIJ total scores, and ASDAS. Across groups, 67.8-81.8% of patients had MRI inflammation. By week 52, IXE demonstrated improvements in ASAS40 (61.2% [normal CRP], 63.0% [elevated CRP]), ASDAS LDA/ID (69.4% [normal CRP], 58.8% [elevated CRP]), and BASDAI50 (55.1% [normal CRP], 63.0% [elevated CRP]) compared with placebo. Similar improvements were observed across CRP groups for patients with MRI evidence of inflammation at weeks 16 and 52.

conclusionPatients with r-axSpA and normal CRP at baseline have a similar disease burden to those with elevated CRP. IXE provides significant clinical benefits across key outcome measures regardless of CRP level. CLINICAL TRIAL REGISTRATION NUMBERS: NCT02696785 and NCT04285229.

Indexed as

Axial spondyloarthritisBiologic disease-modifying antirheumatic drugC-reactive proteinInterleukin-17A inhibitor

Identifiers

PMID42228347
PMCPMC13407819

What OpenQuestion holds

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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.