Evidence map›Paper›PMID 31734899›Full record

ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2020

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry.

Hyoun-Ah Kim, Eunyoung Lee, Sun-Kyung Lee, Yong-Beom Park, Young Nam Lee, Hee Jung Kang, Kichul Shin

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01965132 (Korean College of Rheumatology Biologics and Targeted Therapy Registry), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT01965132 recruitingnot on this map

Korean College of Rheumatology Biologics and Targeted Therapy Registry

Typeobservational_patient_registrySponsorSeoul National University HospitalRan2012 to 2030Enrolled10,000ConditionsRheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic ArthritisArmsBiologic or targeted synthetic DMARD
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

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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

7 authors at 4 institutions in 1 country.

Hyoun-Ah KimDepartment of Rheumatology, Ajou University School of Medicine, Suwon, Republic of Korea.ORCID http://orcid.org/0000-0003-2609-3367
Eunyoung LeeDepartment of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea.
Sun-Kyung LeeDivision of Rheumatology, Seoul Metropolitan Government-Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea.
Yong-Beom ParkDepartment of Internal Medicine (Division of Rheumatology), Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea.
Young Nam LeeCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.ORCID http://orcid.org/0000-0003-2776-4708
Hee Jung KangCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
Kichul ShinDivision of Rheumatology, Seoul Metropolitan Government-Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea. kideb1@gmail.com.ORCID http://orcid.org/0000-0002-6749-7598
Ajou University · KRCelltrion (South Korea) · KRSeoul Metropolitan Government · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry.

methodsPatients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up.

resultsData from 199 RA patients (CT-P13: n = 147; reference infliximab: n = 52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p = 0.84) and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab.

conclusionLong-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile. CLINICALTRIALS. GOV IDENTIFIER: NCT01965132.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsBlood SedimentationDrug SubstitutionFemaleHumansInfliximabMaleMiddle AgedRegistriesRepublic of KoreaRheumatologySeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsBiosimilar PharmaceuticalsCT-P13Infliximab

Identifiers

PMID31734899
PMCPMC6985057
OpenAlexW2985442862

What OpenQuestion holds

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LicenceCC BY-NC
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.