Evidence map›Paper›PMID 38302579›Full record

ArticleScientific reports2024

Detection of novel drug-adverse drug reaction signals in rheumatoid arthritis and ankylosing spondylitis: analysis of Korean real-world biologics registry data.

M Kwon, C I Joung, H Shin, C C Lee, Y S Song, Y J Lee, S Kang, J Y Kim, S Lee

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 48% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

9 authors at 3 institutions in 1 country.

M KwonDepartment of Internal Medicine, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0002-1660-1770
C I JoungDepartment of Internal Medicine, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0002-2204-9214
H ShinHealthcare Data Science Centre, Konyang University Hospital, Daejeon, South Korea.ORCID 0000-0002-1537-0608
C C LeeDepartment of Biomedical Informatics, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0002-1670-6222
Y S SongDepartment of Pathology, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0003-1477-7913
Y J LeeDepartment of Biomedical Informatics, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0003-4479-9136
S KangDepartment of Internal Medicine, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0003-3698-0007
J Y KimDepartment of Biomedical Informatics, School of Medicine, Konyang University, Daejeon, South Korea.ORCID 0000-0003-1230-9307
S LeeDepartment of Computer Engineering, Gachon University, (13120) 1342 Seongnamdaero, Sujeong-gu, Seongnam-si, Gyeonggi-do, South Korea. leesh@gachon.ac.kr.ORCID 0000-0003-0651-6481
Konyang University · KRGachon University · KRKonyang University Hospital · KR

Funding

Konyang University Myung-gok Research Fund 20-06National Research Foundation of Korea 2021R1I1A3044287
6 · The paper itself

Abstract

This study aimed to detect signals of adverse drug reactions (ADRs) associated with biological disease-modifying antirheumatic drugs (DMARDs) and targeted therapies in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients. Utilizing the KOrean College of Rheumatology BIOlogics & Targeted Therapy Registry (KOBIO) data, we calculated relative risks, excluded previously reported drug-ADR pairs, and externally validated remaining pairs using US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and single centre's electronic health records (EHR) data. Analyzing data from 2279 RA and 1940 AS patients, we identified 35 significant drug-ADR pairs in RA and 26 in AS, previously unreported in drug labels. Among the novel drug-ADR pairs from KOBIO, 15 were also significant in the FAERS data. Additionally, 2 significant drug-laboratory abnormality pairs were found in RA using CDM MetaLAB analysis. Our findings contribute to the identification of 14 novel drug-ADR signals, expanding our understanding of potential adverse effects related to biological DMARDs and targeted therapies in RA and AS. These results emphasize the importance of ongoing pharmacovigilance for patient safety and optimal therapeutic interventions.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiological ProductsDrug-Related Side Effects and Adverse ReactionsSpondylitis, AnkylosingHumansPharmaceutical PreparationsRegistriesRepublic of KoreaRoutinely Collected Health DataAntirheumatic AgentsBiological ProductsPharmaceutical Preparations

Identifiers

PMID38302579
PMCPMC10834537
OpenAlexW4391436978

What OpenQuestion holds

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LicenceCC BY
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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.