Evidence map›Paper›PMID 37950790›Full record

ArticleAdvances in therapy2024

Real-World Effectiveness and Safety of SDZ ETN, an Etanercept Biosimilar, in Patients with Rheumatic Diseases: Final Results from Multi-Country COMPACT Study.

Marc Schmalzing, Herbert Kellner, Ayman Askari, Javier De Toro Santos, Julio Cesar Vazquez Perez-Coleman, Rosario Foti, Sławomir Jeka, Boulos Haraoui, Yannick Allanore, Peter Peichl and 8 more

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Observational
  3. 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

18 authors at 10 institutions in 7 countries.

Marc SchmalzingDepartment of Internal Medicine II, University Hospital, Rheumatology/Clinical Immunology, Würzburg, Germany. Schmalzing_M@ukw.de.ORCID 0000-0002-3289-2299
Herbert KellnerCenter for Rheumatology and Gastroenterology, Hospital Neuwittelsbach, Munich, Germany.
Ayman AskariRobert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Shropshire, UK.
Javier De Toro SantosUniversity Hospital Coruña, A Coruña, Spain.
Julio Cesar Vazquez Perez-ColemanRheumatology Department, University Hospital Complex of Ferrol, Ferrol, Spain.
Rosario FotiRheumatology Unit, Policlinico G. Rodolico-S. Marco Hospital, Catania, Italy.
Sławomir JekaClinic and Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum UM K, Bydgoszcz, Poland.
Boulos HaraouiInstitut de Rhumatologie de Montréal, Montréal, Canada.
Yannick AllanoreRheumatology Department, Cochin Hospital, Université de Paris, Paris, France.
Peter PeichlEvangelisches Krankenhaus Vienna, Vienna, Austria.
Martin OehriRheuma-und Schmerzzentrum Frauenfeld, Frauenfeld, Switzerland.
Masiur RahmanSandoz Hexal AG, Holzkirchen, Germany.
Fabricio FurlanSandoz Hexal AG, Holzkirchen, Germany.
Elisa RomeroSandoz Hexal AG, Holzkirchen, Germany.
Sohaib HachaichiSandoz Hexal AG, Holzkirchen, Germany.
Charlotte BothSandoz Hexal AG, Holzkirchen, Germany.
Ines BrueckmannSandoz Hexal AG, Holzkirchen, Germany.
Tom SheeranUniversity of Wolverhampton, New Cross Hospital, Wolverhampton, UK.
Hexal (Germany) · DEBarmherzige Schwestern Krankenhaus Wien · ATComplejo Hospitalario Universitario de Ferrol · ESKantonsspital Frauenfeld · CHMontreal Clinical Research Institute · CARobert Jones and Agnes Hunt Orthopaedic Hospital · GBUniversidade da Coruña · ESUniversitätsklinikum Würzburg · DEUniversité Paris Cité · FRUniversity of Wolverhampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCOMPACT, a non-interventional study, evaluated the persistence, effectiveness, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with SDZ ETN (etanercept [ETN] biosimilar) in Europe and Canada.

methodsPatients (aged ≥ 18 years) who have been treated with SDZ ETN were categorised on the basis of prior treatment status (groups A-D): patients in clinical remission or with low disease activity under treatment with reference ETN or biosimilar ETN and switched to SDZ ETN; patients who received non-ETN targeted therapies and switched to SDZ ETN; biologic-naïve patients who started SDZ ETN after conventional therapy failure; or disease-modifying anti-rheumatic drug (DMARD)-naïve patients with RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. The primary endpoint was drug persistence, defined as time from study enrolment until discontinuation of SDZ ETN treatment.

resultsOf the 1466 patients recruited, 844 (57.6%) had RA, 334 (22.8%) had axSpA and 288 (19.6%) had PsA. Patients had an ongoing SDZ ETN treatment at the time of enrolment for an observed average of 138 days (range 1-841); 22.7% of patients discontinued SDZ ETN through 12 months of study observation. Overall, all the patients receiving SDZ ETN showed good treatment persistence at 12 months with discontinuation rates of 15.2%, 25.7% and 27.8% in groups A, B and C, respectively. Across all patient groups, no major differences were observed in the disease activity and PRO scores between baseline and month 12. Injection-site reactions were low across the treatment groups.

conclusionThese results support the effectiveness and safety of SDZ ETN treatment in patients with RA, axSpA or PsA in real-life conditions. The treatment persistence rates observed were consistent with previously published reports of patients treated with reference or other biosimilar ETN. No new safety signals were identified.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticArthritis, RheumatoidAxial SpondyloarthritisBiosimilar PharmaceuticalsRheumatic DiseasesEtanerceptHumansTreatment OutcomeAntirheumatic AgentsBiosimilar PharmaceuticalsEtanerceptBiosimilarCOMPACTEffectivenessNon-interventionalPersistencePROReal-worldRheumatic diseasesSafetySDZ ETN

Identifiers

PMID37950790
PMCPMC10796424
OpenAlexW4388598609

What OpenQuestion holds

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Registered trials

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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.