Evidence map›Paper›PMID 37353788›Full record

Observational studyArthritis research & therapy2023

Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: results from the PsABio real-world study.

Laure Gossec, Stefan Siebert, Paul Bergmans, Kurt de Vlam, Elisa Gremese, Beatríz Joven-Ibáñez, Tatiana V Korotaeva, Frederic Lavie, Wim Noël, Michael T Nurmohamed and 4 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Arthritis research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02627768 (Assessment of STELARA®), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 28% 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.

NCT02627768 completednot on this map

Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort

TypeobservationalSponsorJanssen Pharmaceutica N.V., BelgiumRan2015 to 2020Enrolled991ConditionsPsoriatic ArthritisArmsNo Intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
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 at 12 institutions in 10 countries.

Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France. laure.gossec@aphp.fr.
Stefan SiebertUniversity of Glasgow, Glasgow, UK.
Paul BergmansJanssen-Cilag BV, Breda, The Netherlands.
Kurt de VlamUniversity Hospitals Leuven, Leuven, Belgium.
Elisa GremeseFondazione Policlinico A Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Beatríz Joven-IbáñezUniversity Hospital, 12 de Octubre, Madrid, Spain.
Tatiana V KorotaevaVA Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
Frederic LavieThe Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France.
Wim NoëlJanssen Pharmaceutica NV, Beerse, Belgium.
Michael T NurmohamedReade and VU University Medical Center, Amsterdam, The Netherlands.
Petros P SfikakisNational and Kapodistrian University of Athens Medical School, Athens, Greece.
Mohamed SharafJohnson and Johnson MEA, Dubai, United Arab Emirates.
Elke TheanderJanssen, Solna, Sweden.
Josef S SmolenMedical University of Vienna, Vienna, Austria.
Istituti di Ricovero e Cura a Carattere Scientifico · ITJanssen (Belgium) · BEJanssen (France) · FRJanssen (Netherlands) · NLLund University · SEMedical University of Vienna · ATNational and Kapodistrian University of Athens · GRPitié-Salpêtrière Hospital · FRReade · NLResearch Institute Hospital 12 de Octubre · ESUniversity of Glasgow · GBVA Nasonova Scientific Research Institute of Rheumatology · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years.

methodsIn PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0-10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA).

resultsIn 437 patients (mean age 49.1 years, 47.8% female), at 3 years, ustekinumab and TNFi treatment led to comparable improvements in EQ-5D VAS; mean change from baseline (95% confidence intervals [CI]) was 11.0 (6.5; 15.4) and 18.9 (14.0; 23.9), respectively. Both groups improved PsAID-12 after 3 years; mean change from baseline (95% CI) was -2.9 (-3.2; -2.5) and -3.5 (-3.9; -3.2), respectively. At baseline, due to their PsA, TNFi-treated patients had lower work productivity compared to ustekinumab-treated patients; mean productivity reduction (95% CI) was 58.8 [52.4; 65.2] and 43.3 [35.6; 51.1]. Over 3 years, TNFi-treated patients had a greater improvement in work productivity compared to ustekinumab-treated patients, ultimately leaving work productivity to be comparable between groups; mean improvement (95% CI) was 44.5% (38.4; 50.6) and 24.9% (15.8; 34.0), respectively. A similar trend was observed in activity impairment. Patients in both treatment groups who achieved effectiveness endpoints, cDAPSA LDA/remission, MDA, and VLDA had greater improvement in PROs and WPAI than patients who did not achieve these endpoints.

conclusionsAt 3 years, improvements in PROs following ustekinumab or TNFi treatment were generally comparable; however, TNFi-treated patients achieved a greater improvement in work productivity, although this group started from a lower baseline. Achievement of effectiveness endpoints, independent of treatment group, also improved PROs.

trial registrationClinicalTrials.gov, NCT02627768. Registered on 11 December 2015.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresProspective StudiesSeverity of Illness IndexTreatment OutcomeTumor Necrosis Factor InhibitorsUstekinumabAntirheumatic AgentsTumor Necrosis Factor InhibitorsUstekinumabPatient-reported outcomesPsoriatic arthritisReal-world evidenceTumour necrosis factor inhibitorUstekinumab

Identifiers

PMID37353788
PMCPMC10288720
OpenAlexW4381804255

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.