Evidence map›Paper›PMID 35833532›Full record

ArticleACR open rheumatology2022

Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study.

Philip C Robinson, Pedro M Machado, Nigil Haroon, Lianne S Gensler, John D Reveille, Vanessa Taieb, Thomas Vaux, Carmen Fleurinck, Marga Oortgiesen, Natasha de Peyrecave and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in ACR open rheumatology, 2022. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02963506 phase2completednot on this map

A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma S.P.R.L.Ran2016 to 2018Enrolled303ConditionsAnkylosing SpondylitisArmsPlacebo, Bimekizumab
NCT03355573 phase2completednot on this map

A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma SRLRan2017 to 2022Enrolled255ConditionsAnkylosing SpondylitisArmsBimekizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

11 authors.

Philip C RobinsonUniversity of Queensland School of Clinical Medicine, Brisbane, Queensland, Australia.ORCID https://orcid.org/0000-0002-3156-3418
Pedro M MachadoUniversity College London, London, UK.
Nigil HaroonToronto Western Hospital, University of Toronto and Schroeder Arthritis Institute, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0003-3210-4771
Lianne S GenslerUniversity California, San Francisco.ORCID https://orcid.org/0000-0001-6314-5336
John D ReveilleThe University of Texas McGovern Medical School, Houston.ORCID https://orcid.org/0000-0001-5950-0913
Vanessa TaiebUCB Pharma, Colombes, France.
Thomas VauxUCB Pharma, Slough, UK.
Carmen FleurinckUCB Pharma, Brussels, Belgium.
Marga OortgiesenUCB Pharma, Raleigh, North Carolina.
Natasha de PeyrecaveUCB Pharma, Brussels, Belgium.
Atul DeodharOregon Health & Science University, Portland.ORCID https://orcid.org/0000-0002-2130-1246

Funding

UCB Pharma
6 · The paper itself

Abstract

objectiveThe impact of the COVID-19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health-related quality of life (HRQoL) through the pandemic in patients with AS.

methodsIn the open-label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID-19 pandemic (September 2019 to April 2021).

resultsA total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID-19 treatment-emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID-19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS-CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre-pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3-month periods immediately before and during the pandemic. ASDAS-CRP, BASDAI, and ASQoL stability was consistent across major study countries.

conclusionDisease activity and HRQoL remained stable during the COVID-19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes.

Identifiers

PMID35833532
PMCPMC9349833

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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.