Evidence map›Paper›PMID 31174584›Full record

Trial reportArthritis research & therapy2019

Spinal radiographic progression over 2 years in ankylosing spondylitis patients treated with secukinumab: a historical cohort comparison.

J Braun, H Haibel, M de Hooge, R Landewé, M Rudwaleit, T Fox, A Readie, H B Richards, B Porter, R Martin and 3 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
–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.

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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Osteoimmunology of Spondyloarthritis.International journal of molecular sciences · 2023
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Bone Involvement in Patients with Spondyloarthropathies.Calcified tissue international · 2022
    Review
  14. Treatment of axial spondyloarthritis: an update.Nature reviews. Rheumatology · 2022
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence.Therapeutic advances in musculoskeletal disease · 2021
    Review
  20. 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

13 authors.

J BraunRheumazentrum Herne, Herne, Germany. juergen.braun@elisabethgruppe.de.ORCID 0000-0002-9156-5095
H HaibelCharité Universitätsmedizin Berlin, Berlin, Germany.
M de HoogeVIB Inflammation Research Center, Ghent University, Ghent, Belgium.
R LandewéMaastricht University Medical Center, Maastricht, Netherlands.
M RudwaleitKlinikum Bielefeld, Bielefeld, Germany.
T FoxNovartis Pharma AG, Basel, Switzerland.
A ReadieNovartis Pharmaceuticals Corporation, East Hanover, USA.
H B RichardsNovartis Pharma AG, Basel, Switzerland.
B PorterNovartis Pharmaceuticals Corporation, East Hanover, USA.
R MartinNovartis Pharmaceuticals Corporation, East Hanover, USA.
D PoddubnyyCharité Universitätsmedizin Berlin, Berlin, Germany.
J SieperCharité Universitätsmedizin Berlin, Berlin, Germany.
D van der HeijdeVIB Inflammation Research Center, Ghent University, Ghent, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS).

methodsBaseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31-743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs.

resultsA total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant.

conclusionSecukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedCervical VertebraeDisease ProgressionFemaleFollow-Up StudiesHumansInterleukin-17Lumbar VertebraeMaleMiddle AgedPrognosisRadiographyRetrospective StudiesAntibodies, Monoclonal, HumanizedInterleukin-17secukinumabAnkylosing spondylitisBiologic therapyInterleukin-17ANonsteroidal anti-inflammatory drugsRadiographic progressionRetrospective cohort studySecukinumab

Identifiers

PMID31174584
PMCPMC6555995

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.