Evidence map›Paper›PMID 36418087›Full record

Observational studyRMD open2022

Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry.

Hafsah Nabi, Oliver Hendricks, Dorte Vendelbo Jensen, Anne Gitte Loft, Jens Kristian Pedersen, Søren Andreas Just, Kamilla Danebod, Heidi Lausten Munk, Salome Kristensen, Natalia Manilo and 13 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 31% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024
    Review
  7. 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

23 authors at 15 institutions in 1 country.

Hafsah NabiDANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark hafsah.nabi@regionh.dk.ORCID 0000-0001-6331-7927
Oliver HendricksDanish Hospital for Rheumatic Disease, University Hospital of Southern Denmark, Sønderborg, Syddanmark, Denmark.
Dorte Vendelbo JensenDepartment of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark.
Anne Gitte LoftDepartment of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.
Jens Kristian PedersenRheumatology Section, Department of Medicine M, Svendborg Hospital, Svendborg, Syddanmark, Denmark.
Søren Andreas JustDepartment of Rheumatology, Svendborg Hospital, Svendborg, Syddanmark, Denmark.ORCID 0000-0002-3946-5919
Kamilla DanebodDepartment of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup, Denmark.
Heidi Lausten MunkDepartment of Rheumatology, Odense University Hospital, Odense C, Denmark.ORCID 0000-0002-2212-6283
Salome KristensenDepartment of Rheumatology, Aalborg University Hospital, Aalborg, Denmark.ORCID 0000-0001-5812-5234
Natalia ManiloDepartment of Rheumatology, Frederiksberg Hospital, Copenhagen, Denmark.
Ada ColicDepartment of Rheumatology, Zealand University Hospital, Køge, Denmark.
Asta LinauskasDepartment of Rheumatology, North Denmark Regional Hospital, Hjørring, Denmark.
Pia Høger ThygesenDepartment of Rheumatology, Slagelse Hospital, Slagelse, Denmark.
Louise Brot ChristensenDepartment of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark.
Maren Høgberget KaliszDepartment of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark.
Niels LomborgDepartment of Rheumatology, Vejle Hospital Lillebælt, Vejle, Denmark.
Stavros ChrysidisDepartment of Rheumatology, Esbjerg Hospital, Esbjerg, Denmark.ORCID 0000-0001-8583-6517
Johnny Lillelund RaunDepartment of Rheumatology, Hospital Lillebælt, Fredericia, Kolding, Denmark.
Marlene AndersenDepartment of Rheumatology, North Denmark Regional Hospital, Hjorring, Nordjylland, Denmark.
Frank MehnertDepartment of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Niels Steen KroghZitelab Aps, Copenhagen, Denmark.
Merete Lund Hetland *DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark.ORCID 0000-0003-4229-6818
Bente Glintborg *DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark.ORCID 0000-0002-8931-8482
Herlev Hospital · DKUniversity of Copenhagen · DKNorth Denmark Region · DKUniversity of Southern Denmark · DKAalborg University Hospital · DKAarhus University · DKAarhus University Hospital · DKFrederiksberg Hospital · DKGlostrup Hospital · DKLillebaelt Hospital · DKOdense University Hospital · DKSlagelse Hospital · DKSvendborg Sygehus · DKVejle Sygehus · DKZealand University Hospital Køge · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSuccessful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).

methodsObservational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.

resultsOf 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.

conclusionThis real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.

Indexed as

Arthritis, PsoriaticArthritis, RheumatoidBiosimilar PharmaceuticalsHumansInfliximabRegistriesTreatment OutcomeBiosimilar PharmaceuticalsInfliximabarthritis, psoriaticarthritis, rheumatoidbiosimilar pharmaceuticalsinfliximabspondylitis, ankylosing

Identifiers

PMID36418087
PMCPMC9685195
OpenAlexW4309822138

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.