Evidence map›Paper›PMID 34647992›Full record

ArticleRheumatology (Oxford, England)2022

Filgotinib decreases both vertebral body and posterolateral spine inflammation in ankylosing spondylitis: results from the TORTUGA trial.

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

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

8 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. JAK Inhibitors for the Treatment of Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2023
    Review
  7. Review
  8. 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

9 authors at 7 institutions in 6 countries.

Walter P MaksymowychDepartment of Medicine, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-1291-1755
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Center of Head and Orthopedics, Rigshospitalet, Glostrup.ORCID 0000-0003-3690-467X
Robert LandewéDepartment of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam.ORCID 0000-0002-0577-6620
William BarchukClinical Research, Gilead Sciences, Inc., Foster City, CA, USA.
Ke LiuClinical Research, Gilead Sciences, Inc., Foster City, CA, USA.
Leen GillesBiometrics, Galapagos NV, Mechelen, Belgium.
Thijs HendrikxMedical Affairs.
Robin BesuyenClinical Development, Galapagos BV, Leiden, Netherlands.ORCID 0000-0002-8699-4549
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University, Bochum, Germany.ORCID 0000-0002-9475-9362
Gilead Sciences (United States) · USGalapagos (Belgium) · BEGalapagos (Netherlands) · NLRheumazentrum Ruhrgebiet · DEUniversity Medical Center · USUniversity of Alberta · CAUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the effects of filgotinib on inflammatory and structural changes at various spinal locations, based on MRI measures in patients with active AS in the TORTUGA trial.

methodsIn the TORTUGA trial, patients with AS received filgotinib 200 mg (n = 58) or placebo (n = 58) once daily for 12 weeks. In this post hoc analysis, spine MRIs were evaluated using the Canada-Denmark (CANDEN) MRI scoring system to assess changes from baseline to week 12 in total spine and subscores for inflammation, fat, erosion and new bone formation (NBF) at various anatomical locations. Correlations were assessed between CANDEN inflammation and clinical outcomes and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scores and between baseline CANDEN NBF and baseline BASFI and BASMI scores.

resultsMRIs from 47 filgotinib- and 41 placebo-treated patients were evaluated. There were significantly larger reductions with filgotinib vs placebo in total spine inflammation score and most inflammation subscores, including posterolateral elements (costovertebral joints, transverse/spinous processes, soft tissues), facet joints and vertebral bodies. No significant differences were observed for corner or non-corner vertebral body inflammation subscores, spine fat lesion, bone erosion or NBF scores. In the filgotinib group, the change from baseline in the total inflammation score correlated positively with the SPARCC spine score. Baseline NBF scores correlated with baseline BASMI but not BASFI scores.

conclusionsCompared with placebo, filgotinib treatment was associated with significant reductions in MRI measures of spinal inflammation, including in vertebral bodies, facet joints and posterolateral elements.

trial registrationClinicalTrials.gov (https://clinicaltrials.gov), NCT03117270.

Indexed as

SpondylarthritisSpondylitis, AnkylosingZygapophyseal JointHumansInflammationMagnetic Resonance ImagingPyridinesSeverity of Illness IndexSpineTriazolesVertebral BodyGLPG0634PyridinesTriazolesASfilgotinibinflammationMRItherapeutics

Identifiers

PMID34647992
PMCPMC9157176
OpenAlexW3205450150

What OpenQuestion holds

Textmetadata
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.