Evidence map›Paper›PMID 39534481›Full record

ArticleTherapeutic advances in musculoskeletal disease2024

Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies.

Lars Erik Kristensen, William Tillett, Peter Nash, Laura C Coates, Philip J Mease, Alexis Ogdie, Paolo Gisondi, Barbara Ink, Adam R Prickett, Rajan Bajracharya and 4 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 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.

NCT03895203 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled852ConditionsPsoriatic ArthritisArmsBimekizumab, Adalimumab, Placebo
NCT03896581 phase3completednot on this map

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

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled400ConditionsPsoriatic ArthritisArmsBimekizumab, Placebo
NCT04009499 phase3completednot on this map

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2026Enrolled1,131ConditionsPsoriatic ArthritisArmsBimekizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

14 authors.

Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Nordre Fasanvej 57, Road 8, Entrance 19, DK-2000 Frederiksberg, Denmark.
William TillettRoyal National Hospital of Rheumatic Diseases, Bath, UK.ORCID https://orcid.org/0000-0001-7531-4125
Peter NashSchool of Medicine, Griffith University, Brisbane, QLD, Australia.
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.ORCID https://orcid.org/0000-0002-4756-663X
Philip J MeaseSwedish Medical Center and Providence St. Joseph Health and University of Washington, Seattle, WA, USA.
Alexis OgdiePerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Paolo GisondiSection of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
Barbara InkUCB, Slough, UK.
Adam R PrickettUCB, Slough, UK.
Rajan BajracharyaUCB, Slough, UK.
Vanessa TaiebUCB, Colombes, France.
Nikos LyrisUCB, Slough, UK.
Jérémy LambertUCB, Colombes, France.
Jessica A WalshDivision of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Psoriatic arthritis (PsA) is a chronic inflammatory disease that causes pain and fatigue, reduces physical function, and negatively impacts health-related quality of life (HRQoL). In the phase III BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrated clinical efficacy and meaningful improvements in patient-reported outcome (PRO) measures in biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, and those who had prior inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR). Objectives: To examine the association between achieving increasingly stringent clinical disease control criteria and improvements in PRO measures in patients with active PsA receiving bimekizumab. Design: Post hoc analysis of two phase III studies. Methods: BE OPTIMAL and BE COMPLETE assessed subcutaneous bimekizumab 160 mg every 4 weeks in bDMARD-naïve and TNFi-IR patients with active PsA. Disease control was assessed using American College of Rheumatology (ACR) response criteria, Minimal Disease Activity, Disease Activity Index for Psoriatic Arthritis, and the composite outcome of ACR50 and 100% improvement in Psoriasis Area and Severity Index. Associations between clinical disease control criteria and PRO measures of pain, fatigue, physical function, and HRQoL were assessed at week 16 and week 52/40 (BE OPTIMAL/BE COMPLETE). Results: Achievement of increasingly stringent clinical disease control criteria was generally associated with sequentially greater improvements in all PRO measures, including pain. At week 52/40, 94.7% of bDMARD-naïve and 97.6% of TNFi-IR patients achieving ACR70 reported ⩾50% improvements in pain from baseline, and the greatest numerical improvements (-48.5 bDMARD-naïve; -54.7 TNFi-IR). This pattern was evident as early as week 16 and sustained when assessed at week 52/40 across the majority of clinical disease control criteria and PRO measures reported. Conclusion: The achievement of increasingly stringent thresholds of disease control was associated with corresponding greater improvements in PROs, for patients receiving bimekizumab treatment, irrespective of prior TNFi use. Trial registration ClinicalTrialsgov: NCT03895203, NCT03896581, and NCT04009499.

Indexed as

bDMARD-naïvebimekizumabdisease controlIL-17patient-reported outcomespsoriatic arthritisTNF inhibitor inadequate response or intolerance

Identifiers

PMID39534481
PMCPMC11555751

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.