Evidence map›Paper›PMID 31113455›Full record

Trial reportArthritis research & therapy2019

Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study.

Min-Chan Park, Hiroaki Matsuno, Jinseok Kim, Sung-Hwan Park, Sang-Heon Lee, Yong-Beom Park, Yun Jong Lee, Sang-Il Lee, Won Park, Dong Hyuk Sheen and 22 more

Registry-linked trialAbstract 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. It is linked to trial NCT02715908 (A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate), which is not on this map. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT02715908 phase3completednot on this map

A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002

TypeinterventionalSponsorLG Life SciencesRan2016 to 2018Enrolled148ConditionsRheumatoid ArthritisArmsLBEC0101
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  12. Targeting ectromelia virus and TNF/NF-κB or STAT3 signaling for effective treatment of viral pneumonia.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  13. Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019
    Review
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

32 authors.

Min-Chan ParkDivision of Rheumatology, Yonsei University College of Medicine, Seoul, South Korea.
Hiroaki MatsunoInstitute of Medical Science, Tokyo Medical University, Tokyo, Japan.
Jinseok KimDivision of Rheumatology, Jeju National University Hospital, Jeju, South Korea.
Sung-Hwan ParkDivision of Rheumatology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
Sang-Heon LeeDivision of Rheumatology, Konkuk University Medical Center, Seoul, South Korea.
Yong-Beom ParkDivision of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Yun Jong LeeDivision of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea.
Sang-Il LeeDivision of Rheumatology, Gyeongsang National University Hospital, Jinju, South Korea.
Won ParkDivision of Rheumatology, Inha University School of Medicine, Incheon, South Korea.
Dong Hyuk SheenDivision of Rheumatology, Eulji University School of Medicine, Daejeon, South Korea.
Jung-Yoon ChoeDivision of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South Korea.
Chan-Bum ChoiDivision of Rheumatology, Hanyang University Hospital, Seoul, South Korea.
Seung-Jae HongDivision of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea.
Chang-Hee SuhDepartment of Rheumatology, Ajou University Hospital, Suwon, South Korea.
Shin-Seok LeeDivision of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, South Korea.
Hoon-Suk ChaDepartment of Medicine, Samsung Medical Center, Seoul, South Korea.
Bin YooDivision of Rheumatology, Asan Medical Center, Seoul, South Korea.
Jin-Wuk HurDepartment of Internal Medicine, Eulji University College of Medicine, Eulji Hospital, Seoul, South Korea.
Geun-Tae KimDivision of Rheumatology, Kosin University Gospel Hospital, Busan, South Korea.
Wan-Hee YooDivision of Rheumatology, Chonbuk National University Hospital, Jeonju, South Korea.
Han Joo BaekDepartment of Medicine, Division of Rheumatology, Gachon University Gil Medical Center, Incheon, South Korea.
Kichul ShinDivision of Rheumatology, Seoul Metropolitan Government-Seoul National University, Boramae Medical Center, Seoul, South Korea.
Seung Cheol ShimDivision of Rheumatology, Chungnam National University Hospital, Daejeon, South Korea.
Hyung-In YangDivision of Rheumatology, Kyung Hee University Hospital at Gangdong, Oriental Hospital, Seoul, South Korea.
Hyun Ah KimDivision of Rheumatology, Hallym University Sacred Heart Hospital, Kyunggi, South Korea.
Kyung-Su ParkDivision of Rheumatology, The Catholic University of Korea, St. Vincent's Hospital, Seoul, South Korea.
In Ah ChoiDivision of Rheumatology, Chungbuk National University Hospital, Cheongju, South Korea.
Jisoo LeeDivision of Rheumatology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.
Masato TomomitsuMochida Pharmaceutical Co., Ltd, Tokyo, Japan.
Seonghye ShinLG Chem Ltd., Seoul, South Korea.
Jiyoon LeeLG Chem Ltd., Seoul, South Korea.
Yeong Wook SongDivision of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Jongno-gu, Seoul, 03080, South Korea. ysong@snu.ac.kr.ORCID 0000-0002-5384-3437

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA).

methodsThis multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100.

resultsA total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively).

conclusionsAdministration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.

trial registrationClinicalTrials.gov, NCT02715908 . Registered 22 March 2016.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsDouble-Blind MethodEtanerceptFemaleHumansImmunoglobulin GMaleMiddle AgedReceptors, Tumor Necrosis FactorTherapeutic EquivalencyTimeTreatment OutcomeAntirheumatic AgentsBiosimilar PharmaceuticalsEtanerceptImmunoglobulin GLBEC0101Receptors, Tumor Necrosis FactorBiosimilarEtanerceptLBEC0101Rheumatoid arthritisSwitch

Identifiers

PMID31113455
PMCPMC6528252

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.