Evidence map›Paper›PMID 34449981›Full record

ArticleACR open rheumatology2021

Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study.

Franz Thiele, Ariane Klein, Anton Hospach, Daniel Windschall, Sonja Mrusek, J Michael Ruehlmann, Gerd Horneff

Open access · goldAbstract read
In one paragraph

Article in ACR open rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. 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

7 authors at 6 institutions in 3 countries.

Franz ThieleAsklepios Clinic Sankt Augustin, Sankt Augustin, Germany.ORCID https://orcid.org/0000-0001-6689-8827
Ariane KleinAsklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of Cologne, Cologne, Germany.ORCID https://orcid.org/0000-0001-9771-8710
Anton HospachKlinikum Stuttgart, Olgahospital Stuttgart, Stuttgart, Germany.ORCID https://orcid.org/0000-0001-5656-9165
Daniel WindschallNorthwest German Rheumatology Center, St. Josef Stift, Sendenhorst, Germany.ORCID https://orcid.org/0000-0003-3156-5103
Sonja MrusekPractice for Paediatric Rheumatology, Baden-Baden, Germany.
J Michael RuehlmannPractice for Paediatric Rheumatology, Goettingen, Germany.
Gerd HorneffAsklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of Cologne, Cologne, Germany.ORCID https://orcid.org/0000-0001-5491-7832
University of Cologne · DEAsklepios Klinik Sankt Augustin · DECenter for Rheumatology · USNephrologisches Zentrum Goettingen · DEOlgahospital · DEVoestalpine (Brazil) · BR

Funding

AbbVie DeutschlandMerck Sharp and DohmePfizerRoche
6 · The paper itself

Abstract

objectiveAnalysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety.

methodsPatients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar after January 1, 2017, were selected from the German BIKER registry (Biologics in Paediatric Rheumatology Registry). Furthermore, patients who started therapy with the originator and switched to a biosimilar during the course of therapy were identified. For both patient groups, disease activity and safety were examined and compared separately.

resultsAfter January 1, 2017, 348 patients started treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). Another 57 patients switched to a biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups. The safety profiles were comparable, and frequencies and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently under biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient-years was comparable before (26.4) and after (32.1) the switch.

conclusionIn patients with JIA who require treatment with etanercept, the originator is still used much more frequently. However, our study highlights the equivalence of etanercept biosimilars for therapy for JIA. Increased use of these biosimilars in pediatric patients can therefore be recommended without hesitation.

Identifiers

PMID34449981
PMCPMC8593791
OpenAlexW3193529706

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.