Evidence map›Paper›PMID 31138316›Full record

Trial reportArthritis research & therapy2019

Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study.

Janusz Jaworski, Marco Matucci-Cerinic, Hendrik Schulze-Koops, Maya H Buch, Eugeniusz J Kucharz, Yannick Allanore, Arthur Kavanaugh, Philip Young, Goran Babic

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 6 pooled it
1.2field-weighted citation impact, top 21% 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

9 citing papers in PubMed, 6 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  7. Trial
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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

9 authors at 7 institutions in 6 countries.

Janusz JaworskiReumatika-Centrum Reumatologii, 02-691, Warsaw, Poland. januszjaworski@ymail.com.
Marco Matucci-CerinicDepartment of Experimental and Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Florence, Italy.
Hendrik Schulze-KoopsDivision of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians-University, Munich, Germany.
Maya H BuchLeeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK.
Eugeniusz J KucharzDepartment of Internal Medicine, Rheumatology and Clinical Immunology, Medical University of Silesia, Katowice, Poland.
Yannick AllanoreCochin Hospital, Rheumatology A department, Paris Descartes University, Paris, France.
Arthur KavanaughUC San Diego School of Medicine, La Jolla, CA, USA.
Philip YoungHexal AG, a Sandoz company, Holzkirchen, Germany.
Goran BabicHexal AG, a Sandoz company, Holzkirchen, Germany.
Hexal (Germany) · DEDélégation Paris 5 · FRLudwig-Maximilians-Universität München · DEMedical University of Silesia · PLNIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversity of California, San Diego · USUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSandoz etanercept (SDZ ETN; GP2015) is an etanercept biosimilar with equivalent efficacy and comparable safety and immunogenicity to reference etanercept (ETN) in patients with moderate-to-severe chronic plaque-type psoriasis.

methodsEQUIRA was a phase III, double-blind study conducted in patients with moderate-to-severe rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs. Eligible patients were randomized 1:1 to receive subcutaneous 50 mg SDZ ETN or ETN, once-weekly, for 24 weeks. At week 24, patients with at least moderate EULAR response in the SDZ ETN group continued SDZ ETN treatment, and those in the ETN group were switched to receive 50 mg SDZ ETN, for up to 48 weeks. Patients received concomitant methotrexate at a stable dose (10-25 mg/week) and folic acid (≥ 5 mg/week). Equivalence between SDZ ETN and ETN for change from baseline in disease activity score including 28 joint count C-reactive protein (DAS28-CRP) at week 24 (primary endpoint) and comparable safety and immunogenicity profile of SDZ ETN and ETN have previously been demonstrated at week 24. Herein, we present the 48-week results of the study after a single switch from ETN to its biosimilar at week 24.

resultsThe least squares mean (standard error) change in DAS28-CRP from baseline up to week 48 was comparable between "continued SDZ ETN" (- 2.90 [0.12], n = 148) and "switched to SDZ ETN" (- 2.78 [0.13], n = 131) groups. The proportion of patients achieving EULAR good/moderate responses based on DAS28-erythrocyte sedimentation rate and ACR20/50/70 response rates were comparable between the two groups. The proportion of patients with at least one treatment-emergent adverse event was 42.9% in the "continued SDZ ETN" and 38.0% in the "switched to SDZ ETN" groups. Serious adverse events occurred in 4 patients in each of the two groups. After week 24, none of the patients in the switched group developed anti-drug antibodies (ADAs), while 4 patients in the continued SDZ ETN group had single-event, very low titer, non-neutralizing ADAs detected.

conclusionsThe 48-week results from the EQUIRA study demonstrate that switch from ETN to SDZ ETN in patients with moderate-to-severe rheumatoid arthritis does not impact the efficacy, safety, or immunogenicity of etanercept.

trial registrationEudraCT number 2012-002009-23 , Registered 19 April 2012-prospectively registered.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsDouble-Blind MethodDrug SubstitutionEtanerceptFemaleHumansMaleMiddle AgedTherapeutic EquivalencyTreatment OutcomeAntirheumatic AgentsBiosimilar PharmaceuticalsEtanerceptGP2015BiosimilarEtanerceptRheumatoid arthritisSDZ ETNSwitchTumor necrosis factor inhibitor

Identifiers

PMID31138316
PMCPMC6540397
OpenAlexW2947535112

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.