Evidence map›Paper›PMID 34352069›Full record

Trial reportRheumatology (Oxford, England)2022

Impact of filgotinib on sacroiliac joint magnetic resonance imaging structural lesions at 12 weeks in patients with active ankylosing spondylitis (TORTUGA trial).

Walter P Maksymowych, Mikkel Østergaard, Robert Landewé, William Barchuk, Ke Liu, Chantal Tasset, Leen Gilles, Thijs Hendrikx, Robin Besuyen, Xenofon Baraliakos

Registry-linked trialOpen access · hybridAbstract 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 trial NCT03117270 (A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT03117270 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2017 to 2018Enrolled116ConditionsAnkylosing SpondylitisArmsfilgotinib, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
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  5. Article
  6. Interferon-JAK-STAT Axis in Bone Metabolism.Current osteoporosis reports · 2026
    Review
  7. Article
  8. Review
  9. JAK Inhibitors for the Treatment of Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2023
    Review
  10. Review
  11. Article
  12. Review
  13. Review
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

10 authors at 7 institutions in 6 countries.

Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, AB, Canada.ORCID 0000-0002-1291-1755
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup.
Robert LandewéDepartment of Rheumatology, Amsterdam University Medical Center, Amsterdam and Zuyderland Medical Center, Heerlen, The Netherlands.
William BarchukClinical Research, Gilead Sciences, Foster City, CA, USA.
Ke LiuClinical Research, Gilead Sciences, Foster City, CA, USA.
Chantal TassetLate Stage Development, Galapagos NV.
Leen GillesBiostatistics, LACO, Contracted by Galapagos NV, Mechelen, Belgium.
Thijs HendrikxMedical Affairs.
Robin BesuyenClinical Development, Galapagos BV, Leiden, The Netherlands.
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.ORCID 0000-0002-9475-9362
Galapagos (Belgium) · BEGilead Sciences (United States) · USGalapagos (Netherlands) · NLRheumazentrum Ruhrgebiet · DEUniversity of Alberta · CAUniversity of Copenhagen · DKZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effect of filgotinib, which preferentially inhibits Janus kinase 1 (JAK1), on MRI measures of structural change in the SI joint in patients with active AS in the TORTUGA trial.

methodsAdults with active AS and inadequate response/intolerance to two or more NSAIDs were randomized 1:1 to filgotinib 200 mg (n = 58) or placebo (n = 58) once daily for 12 weeks. In this post hoc analysis, T1-weighted MRI scans of the SI joint were evaluated by two independent readers using Spondyloarthritis Research Consortium of Canada (SPARCC) Sacroiliac Joint Structural Score (SSS) definitions for erosion, backfill, fat metaplasia and ankylosis. Correlations between SPARCC SSS and improvement in clinical outcomes were also assessed.

resultsMRI scans from 87 patients (48 filgotinib, 39 placebo) were evaluated. At baseline there were no notable differences between filgotinib and placebo for any MRI structural lesion types. From baseline to week 12, filgotinib was associated with a significant reduction in SI joint erosion score (P = 0.02) and an increase in backfill score (P = 0.005) vs placebo, with no significant between-group differences for ankylosis (P = 0.46) or fat metaplasia (P = 0.17). At week 12, the change in SPARCC MRI SI joint inflammation scores correlated positively with erosion scores but negatively with backfill scores.

conclusionThe significant changes in MRI structural lesions induced by filgotinib in the SI joint by week 12 demonstrate that tissue repair can be observed very soon after starting treatment with a JAK1 preferential inhibitor. This could have prognostic implications for development of ankylosis.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT03117270.

Indexed as

Janus Kinase InhibitorsSpondylarthritisSpondylitis, AnkylosingAdultHumansMagnetic Resonance ImagingMetaplasiaPyridinesSacroiliac JointTriazolesGLPG0634Janus Kinase InhibitorsPyridinesTriazolesankylosing spondylitisfilgotinibinflammationmagnetic resonance imagingsacroiliac jointtherapeutics

Identifiers

PMID34352069
PMCPMC9071516
OpenAlexW3188159150

What OpenQuestion holds

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LicenceCC BY
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.