Evidence map›Paper›PMID 31350270›Full record

Trial reportAnnals of the rheumatic diseases2019

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3).

Yoshiya Tanaka, Tsutomu Takeuchi, Sakae Tanaka, Atsushi Kawakami, Manabu Iwasaki, Yeong Wook Song, Yi-Hsing Chen, James Cheng-Chung Wei, Sang-Heon Lee, Mitsuhiro Rokuda and 6 more

Registry-linked trialOpen 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02308163 (Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs), which is not on this map. Cited by 63 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 9 pooled it
13.1field-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.

NCT02308163 phase3completednot on this map

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

TypeinterventionalSponsorAstellas Pharma IncRan2014 to 2017Enrolled509ConditionsRheumatoid ArthritisArmsPeficitinib, Placebo, Etanercept
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 9 syntheses or guidelines pooled it, 105 citations in OpenAlex.

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

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

16 authors at 10 institutions in 3 countries.

Yoshiya Tanaka *University of Occupational and Environmental Health, Japan, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.ORCID 0000-0002-0807-7139
Tsutomu Takeuchi *Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0003-1111-8218
Sakae TanakaUniversity of Tokyo, Tokyo, Japan.
Atsushi KawakamiNagasaki University, Graduate School of Biomedical Sciences, Nagasaki, Japan.
Manabu IwasakiYokohama City University, Yokohama, Japan.
Yeong Wook SongSeoul National University Hospital, Seoul, Republic of Korea.
Yi-Hsing ChenTaichung Veterans General Hospital, Taichung, Taiwan.
James Cheng-Chung WeiDepartment of Medicine, Chung Shan Medical University Hospital, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.
Sang-Heon LeeKonkuk University School of Medicine, Seoul, Republic of Korea.
Mitsuhiro RokudaAstellas Pharma, Inc, Tokyo, Japan.
Hiroyuki IzutsuAstellas Pharma, Inc, Tokyo, Japan.ORCID 0000-0002-2193-8327
Satoshi UshijimaAstellas Pharma, Inc, Tokyo, Japan.
Yuichiro KanekoAstellas Pharma, Inc, Tokyo, Japan.
Rio AkazawaAstellas Pharma, Inc, Tokyo, Japan.
Teruaki ShiomiAstellas Pharma, Inc, Tokyo, Japan.
Emi YamadaAstellas Pharma, Inc, Tokyo, Japan.
Astellas Pharma (Japan) · JPChina Medical University · TWKeio University · JPKonkuk University · KRNagasaki University · JPSeoul National University Hospital · KRTaichung Veterans General Hospital · TWThe University of Tokyo · 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

objectivesTo investigate the efficacy and safety of peficitinib, an oral Janus kinase inhibitor, in patients with rheumatoid arthritis (RA).

methodsIn this double-blind phase III study, patients with RA and an inadequate response to prior disease-modifying anti-rheumatic drugs (DMARDs) were randomised to peficitinib 100 mg once daily, peficitinib 150 mg once daily, placebo or open-label etanercept for 52 weeks' treatment; placebo-treated patients were switched at week 12 to peficitinib 100 or 150 mg once daily. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12/early termination (ET). Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements.

resultsIn total, 507 patients received treatment. ACR20 response rates at week 12/ET were significantly higher in the peficitinib 100 mg (57.7%) and 150 mg (74.5%) groups versus placebo (30.7%) (p<0.001). ACR50/70 response rates were also higher for both peficitinib doses versus placebo. Improvements in ACR response were maintained until week 52. Changes from baseline in DAS28-C-reactive protein/erythrocyte sedimentation rate and the ACR core set were significantly greater for both peficitinib doses versus placebo at week 12/ET (p<0.001). AE incidence was similar across treatment arms. Incidence of serious infection and herpes zoster-related disease was higher with peficitinib versus placebo, but with no clear dose-dependent increase.

conclusionsIn patients with RA and inadequate response to DMARDs, peficitinib 100 mg once daily or 150 mg once daily was efficacious in reducing RA symptoms and was well tolerated compared with placebo. TRIAL REGISTRATION NUMBER: NCT02308163.

Indexed as

AdamantaneAdultAgedAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationC-Reactive ProteinDouble-Blind MethodDrug SubstitutionFemaleHerpes ZosterHumansImmunosuppressive AgentsInfectionsJanus Kinase InhibitorsJapanAdamantaneAntirheumatic AgentsC-Reactive ProteinImmunosuppressive AgentsJanus Kinase InhibitorsNiacinamidepeficitinibDAS28disease activitydmards (synthetic)rheumatoid arthritistreatment

Identifiers

PMID31350270
PMCPMC6788921
OpenAlexW2965006635

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.