Evidence map›Paper›PMID 38599650›Full record

Trial reportRMD open2024

Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2.

Victoria Navarro-Compán, Sofia Ramiro, Atul Deodhar, Philip J Mease, Martin Rudwaleit, Christine de la Loge, Carmen Fleurinck, Vanessa Taieb, Michael F Mørup, Ute Massow and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2024. 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. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03928704 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2023Enrolled274ConditionsNonradiographic Axial SpondyloarthritisArmsBimekizumab, Placebo
NCT03928743 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled332ConditionsAnkylosing SpondylitisArmsBimekizumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Victoria Navarro-CompánDepartment of Rheumatology, La Paz University Hospital, Madrid, Spain mvictoria.navarroc@gmail.com.ORCID 0000-0002-4527-852X
Sofia RamiroDepartment of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-8899-9087
Atul DeodharDivision of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Philip J MeaseSchool of Medicine, Swedish Medical Center and University, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Martin RudwaleitInternal Medicine and Rheumatology, Klinikum Bielefeld Rosenhöhe, Bielefeld, Germany.ORCID 0000-0001-5445-548X
Christine de la LogePCOM Analytics, Avallon, France.
Carmen FleurinckUCB Pharma, Brussels, Belgium.
Vanessa TaiebUCB Pharma, Colombes, France.
Michael F MørupUCB Pharma, Copenhagen, Denmark.
Ute MassowUCB Pharma, Monheim am Rhein, Germany.
Jonathan KayDivision of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA.ORCID 0000-0002-8970-4260
Marina MagreyCase Western Reserve University, Cleveland, Ohio, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA).

methodsPatients in BE MOBILE 1 and 2 achieving different levels of response or disease activity (Assessment of SpondyloArthritis International Society (ASAS) and Ankylosing Spondylitis Disease Activity Score (ASDAS) response criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50)) at week 52 were pooled, regardless of treatment arm. Associations between achievement of these endpoints and change from baseline (CfB) in patient-reported outcomes (PROs) measuring core axSpA domains, including pain, fatigue, physical function, overall functioning and health, and work and employment, were assessed.

resultsAchievement of increasingly stringent clinical efficacy endpoints at week 52 was generally associated with sequentially greater improvements from baseline in all PROs. Patients with nr-axSpA achieving ASAS40 demonstrated greater improvements (CfB) than patients who did not achieve ASAS40 but did achieve ASAS20, in total spinal pain (-5.3 vs -2.8, respectively), Functional Assessment of Chronic Illness-Fatigue subscale (12.7 vs 6.7), Bath Ankylosing Spondylitis Function Index (-3.9 vs -1.8), European Quality of Life 5-Dimension 3-Level Version (0.30 vs 0.16), Work Productivity and Activity Impairment-axSpA presenteeism (-35.4 vs -15.9), overall work impairment (-36.5 vs -12.9), activity impairment (-39.0 vs -21.0) and sleep (9.0 vs 3.9). Results were similar for ASDAS and BASDAI50. Similar amplitudes of improvement were observed between patients with nr-axSpA and r-axSpA.

conclusionsPatients treated with bimekizumab across the full axSpA disease spectrum, who achieved increasingly stringent clinical response criteria and lower disease activity at week 52, reported larger improvements in core axSpA domains.

Indexed as

Non-Radiographic Axial SpondyloarthritisSpondylarthritisSpondylitis, AnkylosingHumansPainQuality of LifeHealth-Related Quality Of LifePatient Reported Outcome MeasuresSpondylitis, AnkylosingTherapeutics

Identifiers

PMID38599650
PMCPMC11015249

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.