Evidence map›Paper›PMID 29191819›Full record

Trial reportAnnals of the rheumatic diseases2018

Efficacy and safety of tocilizumab in patients with refractory Takayasu arteritis: results from a randomised, double-blind, placebo-controlled, phase 3 trial in Japan (the TAKT study).

Yoshikazu Nakaoka, Mitsuaki Isobe, Syuji Takei, Yoshiya Tanaka, Tomonori Ishii, Shumpei Yokota, Akira Nomura, Seitaro Yoshida, Norihiro Nishimoto

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 148 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 13 pooled it
27.2field-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

148 citing papers in PubMed, 13 syntheses or guidelines pooled it, 373 citations in OpenAlex.

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88 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 3 countries.

Yoshikazu NakaokaDepartment of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan.
Mitsuaki IsobeDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Syuji TakeiFaculty of Medicine, School of Health Sciences, Kagoshima University, Kagoshima, Japan.
Yoshiya TanakaFirst 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.
Shumpei YokotaLaboratory of Pediatric Research, Institute of Tokyo Medical School, Tokyo, Japan.
Akira NomuraChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Seitaro YoshidaChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Norihiro NishimotoDepartment of Molecular Regulation for Intractable Disease, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan.
Chugai Pharma (United States) · USTokyo Medical University · JPKagoshima University · JPNational Cerebral and Cardiovascular Center · JPTohoku University Hospital · JPTokyo Medical and Dental University · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

methodsPatients with TAK who had relapsed within the previous 12 weeks were induced into remission with oral glucocorticoid therapy. In this double-blind, placebo-controlled trial, patients were randomly assigned 1:1 to receive weekly tocilizumab 162 mg or placebo subcutaneously, and oral glucocorticoids were tapered 10 %/week from week 4 to a minimum of 0.1 mg/kg/day until 19 patients relapsed. The primary endpoint was time to relapse of TAK, defined as ≥2 of the following: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms or ischaemic symptoms.

resultsThe intent-to-treat and safety populations included 18 tocilizumab-treated and 18 placebo-treated patients. The per-protocol set (PPS) included 16 tocilizumab-treated and 17 placebo-treated patients. HRs for time to relapse of TAK were 0.41 (95.41% CI 0.15 to 1.10; p=0.0596) in the intent-to-treat population (primary endpoint) based on relapse in eight tocilizumab-treated and 11 placebo-treated patients and 0.34 (95.41% CI 0.11 to 1.00; p=0.0345) in the PPS. The secondary endpoints, time to relapse assessed by Kerr's definition and clinical symptoms only, were consistent with the primary endpoint. Serious adverse events were reported in one tocilizumab-treated and two placebo-treated patients. There were no serious infections and no deaths.

conclusionAlthough the primary endpoint was not met, the results suggest favour for tocilizumab over placebo for time to relapse of TAK without new safety concerns. Further investigation is warranted to confirm the efficacy of tocilizumab in patients with refractory TAK. TRIAL REGISTRATION NUMBER: JapicCTI-142616.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleGlucocorticoidsHumansIntention to Treat AnalysisJapanKaplan-Meier EstimateMaleMiddle AgedReceptors, Interleukin-6Remission InductionTakayasu ArteritisAntibodies, Monoclonal, HumanizedGlucocorticoidsReceptors, Interleukin-6tocilizumabcorticosteroids

Identifiers

PMID29191819
PMCPMC5867398
OpenAlexW2773804470

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.