Evidence map›Paper›PMID 29334721›Full record

Trial reportThe Korean journal of internal medicine2019

Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis.

Han Joo Baek, Mie Jin Lim, Won Park, Sung Hwan Park, Seung-Cheol Shim, Dae-Hyun Yoo, Hyun Ah Kim, Soo Kon Lee, Yun Jong Lee, Young Eun Park and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Korean journal of internal medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 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.

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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  14. Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.Joint Commission journal on quality and patient safety · 2019
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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

12 authors.

Han Joo BaekDivision of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
Mie Jin LimDivision of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Won ParkDivision of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Sung Hwan ParkDivision of Rheumatology, Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
Seung-Cheol ShimDivision of Rheumatology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.
Dae-Hyun YooDivision of Rheumatology, Department of Internal Medicine, Hanyang University Seoul Hospital, Seoul, Korea.
Hyun Ah KimDivision of Rheumatology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Soo Kon LeeDivision of Rheumatology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Yun Jong LeeDivision of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Young Eun ParkDivision of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Hoon-Suk ChaDivision of Rheumatology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Yeong-Wook SongDivision of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTo investigate the efficacy and safety of tocilizumab (TCZ) humanized anti-interleukin-6 receptor monoclonal antibody, in Korean patients with active rheumatoid arthritis (RA) refractory to conventional disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX).

methodsThe main study was a 24-week, randomized, double-blind, controlled trial that was followed by a 48-week, open-labeled, extension phase. TCZ (8 mg/kg) or placebo was intravenously administered every 4 weeks.

resultsThose treated with TCZ showed more favorable outcomes in terms of 20% according to the American College of Rheumatology response criteria (ACR20) and ACR50 responses, individual parameters of ACR core set, disease activity score in 28 joints (DAS28) remission, and European League Against Rheumatism (EULAR) response at week 24. These improvements were maintained or increased during the extension period. DAS28 remission at week 72 was associated with EULAR good response at week 12. The patients who experienced any adverse event (AE) were more frequent in the TCZ group compared to the placebo group. Most AEs were mild or moderate in intensity, although TCZ therapy had possible AEs including serious infection, abnormal liver function, and atherogenic lipid profile.

conclusionTCZ infusion add-on is highly efficacious and well-tolerated in Korean patients with active RA refractory to conventional DMARDs including MTX. EULAR good response at week 12 could predict DAS28 remission at week 72.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHumansJointsMaleMiddle AgedRecovery of FunctionRemission InductionRepublic of KoreaTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentstocilizumabArthritis, rheumatoidKoreanTocilizumab

Identifiers

PMID29334721
PMCPMC6610180

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.