Evidence map›Paper›PMID 35789257›Full record

Trial reportRheumatology (Oxford, England)2023

Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE.

Philip J Mease, Akihiko Asahina, Dafna D Gladman, Yoshiya Tanaka, William Tillett, Barbara Ink, Deepak Assudani, Christine de la Loge, Jason Coarse, Jason Eells and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT02969525 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 Active Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma S.P.R.L.Ran2016 to 2018Enrolled206ConditionsPsoriatic ArthritisArmsPlacebo, Bimekizumab
NCT03347110 phase2completednot on this map

A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2017 to 2020Enrolled184ConditionsPsoriatic ArthritisArmsBimekizumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Monotherapy or combination therapy in PsA: current aspects.Therapeutic advances in musculoskeletal disease · 2024
    Review
  6. Review
  7. Review
  8. Review
  9. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 5 countries.

Philip J MeaseSwedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.ORCID 0000-0002-6620-0457
Akihiko AsahinaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Dafna D GladmanSchroeder Arthritis Institute, Krembil Research Institute, University Health Network, Institute of Medical Science, University of Toronto, Toronto, Canada.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
William TillettDepartment of Pharmacy and Pharmacology, University of Bath, Bath.ORCID 0000-0001-7531-4125
Barbara InkUCB Pharma, Slough, UK.
Deepak AssudaniUCB Pharma, Slough, UK.
Christine de la LogeUCB Pharma, Braine l'Alleud, France.
Jason CoarseUCB Pharma, Raleigh, NC, USA.
Jason EellsUCB Pharma, Slough, UK.
Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique.
UCB Pharma (United Kingdom) · GBInserm · FRJikei University School of Medicine · JPProvidence College · USUCB Pharma (France) · FRUCB Pharma (United States) · USUniversity Health Network · CAUniversity of Bath · GBUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesEvaluate effects of long-term bimekizumab treatment on patient-reported outcome (PRO) measures, symptoms and the impact of PsA on patients.

methodsPatients with active PsA were enrolled into BE ACTIVE, a 48-week randomised controlled trial (NCT02969525). After Week 48, patients could enter a 104-week open-label extension (NCT03347110), receiving bimekizumab 160 mg every four weeks. PRO measures assessed included arthritis pain visual analogue scale (VAS), PsA Impact of Disease (PsAID)-9, 36-Item Short Form Survey (SF-36) and HAQ-Disability Index (HAQ-DI). Results were analysed as mean (S.E.M.) changes from baseline (CfB) from Week 0 to the end of the open-label extension (3 years) and as percentage of patients reaching patient-acceptable symptom state (PASS) for global impact (PsAID-9 total score ≤4) and normal function (HAQ-DI total score <0.5). Non-responder imputation was applied to missing binary outcomes.

resultsIn 206 patients (mean age 49.3 years, 51.0% male), completion rate was high; 161 (78.2%) patients completed Week 152. Bimekizumab treatment was associated with long-term sustained improvements in pain [arthritis pain VAS CfB; Week 48: -29.9 (1.9); Week 152: -32.0 (1.9)] and fatigue [PsAID-9 fatigue CfB; -2.4 (0.2); -2.7 (0.2)]. High percentages of patients achieved acceptable symptom state (PsAID-9 PASS: 75.2%; 65.0%) and normalised function (HAQ-DI <0.5: 49.0%; 46.1%). Improvements in patient global assessment and SF-36 Physical Component Summary were also sustained.

conclusionsBimekizumab treatment was associated with long-term sustained improvements in pain and fatigue, reducing overall impact of PsA on patients. Physical function and quality of life improved up to 3 years.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT02969525, NCT03347110.

Indexed as

Arthritis, PsoriaticAntibodies, Monoclonal, HumanizedDouble-Blind MethodFatigueFemaleHumansMaleMiddle AgedPainQuality of LifeTreatment OutcomeAntibodies, Monoclonal, Humanizedbimekizumabbimekizumabfatiguepainpatient-reported outcome measuresphysical functionpsoriatic arthritis

Identifiers

PMID35789257
PMCPMC9891423
OpenAlexW4283816671

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.