Evidence map›Paper›PMID 25880658›Full record

Trial reportArthritis research & therapy2015

Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry.

Ryoko Sakai, Soo-Kyung Cho, Toshihiro Nanki, Kaori Watanabe, Hayato Yamazaki, Michi Tanaka, Ryuji Koike, Yoshiya Tanaka, Kazuyoshi Saito, Shintaro Hirata and 15 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04115423 (A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT04115423 unknown statusnot on this mapstarted 2020, after this paper: background citation

A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database

TypeobservationalSponsorSungkyunkwan UniversityRan2020 to 2021Enrolled9,508ConditionsInfection, Rheumatoid ArthritisArmsTocilizumab, Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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  15. Adverse Effects of Immunosuppression: Infections.Handbook of experimental pharmacology · 2022
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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

25 authors at 12 institutions in 2 countries.

Ryoko SakaiDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. sakai.phv@tmd.ac.jp.
Soo-Kyung ChoDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. aushalten@naver.com.
Toshihiro NankiDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. nanki.rheu@tmd.ac.jp.
Kaori WatanabeDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. watanabe.rheu@tmd.ac.jp.
Hayato YamazakiDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. yamazaki.rheu@tmd.ac.jp.
Michi TanakaDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. tanaka.phv@tmd.ac.jp.
Ryuji KoikeDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. koike.rheu@tmd.ac.jp.
Yoshiya TanakaThe First Department of Internal medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Kitakyushu Yahatanishi-ku, Fukuoka, 807-0804, Japan. tanaka@med.uoeh-u.ac.jp.
Kazuyoshi SaitoThe First Department of Internal medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Kitakyushu Yahatanishi-ku, Fukuoka, 807-0804, Japan. kazu-s@med.uoeh-u.ac.jp.
Shintaro HirataThe First Department of Internal medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Kitakyushu Yahatanishi-ku, Fukuoka, 807-0804, Japan. s-hirata@med.uoeh-u.ac.jp.
Koichi AmanoDepartment of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe-shi, Saitama, 350-8550, Japan. amanokoi@saitama-med.ac.jp.
Hayato NagasawaDepartment of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe-shi, Saitama, 350-8550, Japan. nagasawa@saitama-med.ac.jp.
Takayuki SumidaDivision of Clinical Immunology, Doctoral Program in Clinical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, Ibaraki, 305-0006, Japan. tsumida@md.tsukuba.ac.jp.
Taichi HayashiDivision of Clinical Immunology, Doctoral Program in Clinical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, Ibaraki, 305-0006, Japan. taichi8.th@gmail.com.
Takahiko SugiharaDepartment of Rheumatology, Tokyo Metropolitan Geriatric Hospital, 35-2, Sakaecho, Itabashi-ku, Tokyo, 173-0015, Japan. takahiko_sugihara@tmghig.jp.
Hiroaki DobashiDepartment of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan. hdobashi@med.kagawa-u.ac.jp.
Shinsuke YasudaDivision of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Kita 15. Nishi 7, Kita-ku, Sapporo, 060-8638, Japan. syasuda@med.hokudai.ac.jp.
Tetsuji SawadaDepartment of Rheumatology, Tokyo Medical University, Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo, 160-0023, Japan. tsawada@tokyo-med.ac.jp.
Kazuhiko EzawaDepartment of Internal Medicine, Kurashiki Kousai Hospital, 3542-1, Nakasho, Kurashiki-shi, Okayama, 710-0016, Japan. wakoukai@po.harenet.ne.jp.
Atsuhisa UedaDepartment of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. aueda@med.yokohama-cu.ac.jp.
Takao FujiiDepartment of the Control for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Yoshidakonoecho, Sakyo-ku, Kyoto, 606-8501, Japan. takfujii@kuhp.kyoto-u.ac.jp.
Kiyoshi MigitaDepartment of Rheumatology, National Hospital Organization Nagasaki Medical Center, 2-1001-1, Kubara, Omura, Nagasaki, 856-8562, Japan. migita@nagasaki-mc.com.
Nobuyuki MiyasakaDepartment of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. miya.rheu@tmd.ac.jp.
Masayoshi HarigaiDepartment of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. mharigai.mpha@tmd.ac.jp.
REAL Study Group
Tokyo Medical and Dental University · JPUniversity of Occupational and Environmental Health Japan · JPSaitama Medical University · JPUniversity of Tsukuba · JPHokkaido University · JPKagawa University · JPKurashiki Central Hospital · JPKyoto University · JPNagasaki Medical Center · JPTokyo Medical University · JPTokyo Metropolitan Geriatric Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice.

methodsThis prospective cohort study included RA patients starting TCZ [TCZ group, n=302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n=304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis.

resultsPatients in the TCZ group had longer disease duration (P<0.001), higher disease activity (P=0.019) and more frequently used concomitant corticosteroids (P<0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37).

conclusionsThe adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.

Indexed as

RegistriesAntibodies, Monoclonal, HumanizedArthritis, RheumatoidFemaleFollow-Up StudiesHumansIncidenceJapanMaleMiddle AgedProspective StudiesRisk FactorsTime FactorsTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, Monoclonal, HumanizedtocilizumabTumor Necrosis Factor-alpha

Identifiers

PMID25880658
PMCPMC4384380
OpenAlexW2147335241

What OpenQuestion holds

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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.