Evidence map›Paper›PMID 31951279›Full record

Trial reportRheumatology (Oxford, England)2020

Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.

Yoshikazu Nakaoka, Mitsuaki Isobe, Yoshiya Tanaka, Tomonori Ishii, Seido Ooka, Hiroaki Niiro, Naoto Tamura, Shogo Banno, Hajime Yoshifuji, Yasushi Sakata and 15 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
10.5field-weighted citation impact, top 1% 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

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Pooled it
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  8. Article
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  11. Management of Takayasu Arteritis - A 2026 Update.Current rheumatology reports · 2026
    Review
  12. Article
  13. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 1 country.

Yoshikazu NakaokaDepartment of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Suita Japan.
Mitsuaki IsobeSakakibara Heart Institute, Tokyo Japan.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu Japan.
Tomonori IshiiClinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai Japan.
Seido OokaDivision of Rheumatology and Allergology, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki Japan.
Hiroaki NiiroDepartment of Medical Education, Faculty of Medical Sciences, Kyushu University, Fukuoka Japan.
Naoto TamuraDepartment of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo Japan.
Shogo BannoDivision of Nephrology and Rheumatology, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute Japan.
Hajime YoshifujiDepartment of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto Kyoto, Japan.
Yasushi SakataDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka Japan.
Atsushi KawakamiDepartment of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki Japan.
Tatsuya AtsumiDivision of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo Japan.
Shunsuke FurutaDepartment of Allergy and Clinical Immunology, Chiba University Hospital, Chiba Japan.
Hitoshi KohsakaDepartment of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo Japan.
Katsuya SuzukiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo Japan.
Ryoki HaraDepartment of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama Japan.
Yasuhiro MaejimaDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo Japan.
Hiroshi TsukamotoDepartment of Rheumatology, Shin-Kokura Hospital, Kitakyushu Japan.
Yoshinari TakasakiJuntendo University Koshigaya Hospital, Juntendo University Faculty of Medicine, Saitama Japan.
Katsuhisa YamashitaChugai Pharmaceutical Co., Ltd, Tokyo Japan.
Norihiro OkadaChugai Pharmaceutical Co., Ltd, Tokyo Japan.
Shinji YamakidoChugai Pharmaceutical Co., Ltd, Tokyo Japan.
Syuji TakeiPediatrics and Developmental Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima Japan.
Shumpei YokotaPediatric Rheumatology, Fuji Toranomon Orthopedics Hospital, Shizuoka, Japan.
Norihiro NishimotoDepartment of Molecular Regulation for Intractable Diseases, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.
Osaka University · JPTokyo Medical and Dental University · JPAichi Medical University · JPChiba University Hospital · JPDokkyo Medical University Saitama Medical Center · JPHokkaido University · JPJuntendo University · JPKagoshima University · JPKeio University · JPKyoto University · JPKyushu University · JPNagasaki University · JPSakakibara Hospital · JPShinKokura Hospital · JPSt. Marianna University School of Medicine · JPTohoku University Hospital · JPTokyo Medical University · JPToranomon Hospital · JPUniversity of Occupational and Environmental Health Japan · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the long-term efficacy and safety of the IL-6 receptor antibody tocilizumab in patients with Takayasu arteritis (TAK).

methodsPatients completing the randomized, double-blind, placebo-controlled period of the TAKT (Takayasu arteritis Treated with Tocilizumab) trial were followed up during open-label extended treatment with weekly s.c. tocilizumab 162 mg for up to 96 weeks or longer, with oral glucocorticoid tapering performed at the investigators' discretion. Endpoints of the extension analysis included steroid-sparing effects of tocilizumab, imaging data, patient-reported outcomes (36-Item Short Form Health Survey) and safety.

resultsAll 36 patients enrolled in the double-blind period entered the open-label extension; 28 patients received tocilizumab for 96 weeks. The median glucocorticoid dose was 0.223 mg/kg/day at the time of relapse before study entry, 0.131 mg/kg/day (interquartile range 0.099, 0.207) after 48 weeks and 0.105 mg/kg/day (interquartile range 0.039, 0.153) after 96 weeks. Overall, 46.4% of patients reduced their dose to <0.1 mg/kg/day, which was less than half the dose administered at relapse before study entry (mean difference -0.120 mg/kg/day; 95% CI -0.154, -0.087). Imaging evaluations indicated that most patients' disease was improved (17.9%) or stable (67.9%) after 96 weeks compared with baseline. Mean 36-Item Short Form Health Survey physical and mental component summary scores and 7 of 8 domain scores were clinically improved from baseline and maintained over 96 weeks of tocilizumab treatment. No unexpected safety issues were reported.

conclusionThese results in patients with Takayasu arteritis provide evidence of a steroid-sparing effect and improvements in well-being during long-term treatment with once-weekly tocilizumab 162 mg, with no new safety concerns.

trial registrationJAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-142616.

Indexed as

Time FactorsAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Therapy, CombinationFemaleGlucocorticoidsHumansInduction ChemotherapyMaleRecurrenceTakayasu ArteritisTreatment OutcomeAntibodies, Monoclonal, HumanizedGlucocorticoidstocilizumabbiological therapiesimmunosuppressantsquality of lifeTakayasu arteritisvasculitis

Identifiers

PMID31951279
PMCPMC7449811
OpenAlexW2999068470

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.