Evidence map›Paper›PMID 31350269›Full record

Trial reportAnnals of the rheumatic diseases2019

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan.

Tsutomu Takeuchi, Yoshiya Tanaka, Sakae Tanaka, Atsushi Kawakami, Manabu Iwasaki, Kou Katayama, Mitsuhiro Rokuda, Hiroyuki Izutsu, Satoshi Ushijima, Yuichiro Kaneko and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized 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 NCT02305849 (Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX), which is not on this map. Cited by 72 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 12 pooled it
14.5field-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.

NCT02305849 phase3completednot on this map

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

TypeinterventionalSponsorAstellas Pharma IncRan2014 to 2017Enrolled519ConditionsRheumatoid ArthritisArmsPeficitinib, Placebo, Methotrexate
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 12 syntheses or guidelines pooled it, 126 citations in OpenAlex.

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12 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

13 authors at 7 institutions in 2 countries.

Tsutomu Takeuchi *Keio University School of Medicine, Tokyo, Japan tsutake@z5.keio.jp.ORCID 0000-0003-1111-8218
Yoshiya Tanaka *University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Sakae TanakaThe University of Tokyo, Tokyo, Japan.
Atsushi KawakamiNagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Manabu IwasakiYokohama City University, Yokohama, Japan.
Kou KatayamaKatayama Orthopedic Rheumatology Clinic, Asahikawa, Japan.
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.
Teruaki ShiomiAstellas Pharma Inc, Tokyo, Japan.
Emi YamadaAstellas Pharma Inc, Tokyo, Japan.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-5781-158X
Astellas Pharma (Japan) · JPKeio University · JPLeiden University Medical Center · NLNagasaki University · JPThe 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

objectiveTo evaluate the efficacy and safety of the oral Janus kinase (JAK) inhibitor peficitinib versus placebo in Japanese patients with rheumatoid arthritis (RA).

methodsIn this multicentre, double-blind, parallel-group, placebo-controlled phase III study, patients with RA and inadequate response to methotrexate (MTX) were randomised 1:1:1 to placebo, peficitinib 100 mg once daily or peficitinib 150 mg once daily with MTX for 52 weeks. Based on baseline randomisation, at week 12, non-responders receiving placebo were switched to peficitinib until the end of treatment; the remaining patients were switched to peficitinib at week 28. Primary efficacy variables were American College of Rheumatology (ACR)20 response rate at week 12/early termination (ET) and change from baseline in van der Heijde-modified total Sharp score (mTSS) at week 28/ET.

results519 patients were randomised and treated. Significantly more (p<0.001) peficitinib (58.6%, 100 mg; 64.4%, 150 mg) than placebo (21.8%) recipients achieved ACR20 response at week 12/ET. Significantly lower (p<0.001) mean changes from baseline in mTSS at week 28/ET occurred in peficitinib (1.62, 100 mg; 1.03, 150 mg) than placebo (3.37) recipients. Peficitinib was associated with haematological and biochemical parameter changes, and increased incidence of serious infections and herpes zoster-related disease. One death from suicide occurred in a patient in the placebo group after switching to peficitinib 100 mg.

conclusionsIn Japanese patients with RA and inadequate response to MTX, peficitinib demonstrated significant superiority versus placebo in reducing RA symptoms and suppressing joint destruction. Peficitinib had an acceptable safety and tolerability profile, with no new safety signals compared with other JAK inhibitors. TRIAL REGISTRATION NUMBER: NCT02305849.

Indexed as

AdamantaneAdultAgedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug SubstitutionFemaleHerpes ZosterHumansImmunosuppressive AgentsInfectionsJanus Kinase InhibitorsJapanMaleMethotrexateAdamantaneAntirheumatic AgentsImmunosuppressive AgentsJanus Kinase InhibitorsMethotrexateNiacinamidepeficitinibDAS28disease activitymethotrexaterheumatoid arthritistreatment

Identifiers

PMID31350269
PMCPMC6788880
OpenAlexW2966824117

What OpenQuestion holds

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LicenceCC BY-NC
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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.