Evidence map›Paper›PMID 26672064›Full record

Trial reportAnnals of the rheumatic diseases2016

Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study.

Tsutomu Takeuchi, Yoshiya Tanaka, Manabu Iwasaki, Hiroaki Ishikura, Satoshi Saeki, Yuichiro Kaneko

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01649999 (Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients), which is not on this map. Cited by 80 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 11 pooled it
9.4field-weighted citation impact, top 2% 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.

NCT01649999 phase2completednot on this map

Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients

TypeinterventionalSponsorAstellas Pharma IncRan2012 to 2013Enrolled281ConditionsArthritis, RheumatoidArmspeficitinib, Placebo
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 11 syntheses or guidelines pooled it, 145 citations in OpenAlex.

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20 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

6 authors at 4 institutions in 1 country.

Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Manabu IwasakiDepartment of Computer and Information Science, Seikei University, Tokyo, Japan.
Hiroaki IshikuraAstellas Phama Inc., Tokyo, Japan.
Satoshi SaekiAstellas Phama Inc., Tokyo, Japan.
Yuichiro KanekoAstellas Phama Inc., Tokyo, Japan.
Astellas Pharma (Japan) · JPKeio University · JPSeikei University · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy, safety and dose response of a novel oral Janus kinase inhibitor, peficitinib (ASP015K), as monotherapy in Japanese patients with moderate to severe rheumatoid arthritis (RA).

methodsIn a 12-week, double-blind study, 281 adult patients with RA with active disease not on concomitant disease-modifying antirheumatic drug therapy were randomised equally to once-daily placebo or peficitinib 25, 50, 100 and 150 mg. The primary endpoint was American College of Rheumatology (ACR) 20 response in the peficitinib treatment groups versus placebo at week 12.

resultsMean age was 53.0 years, 81.1% were female and 25.3% had previously used antitumour necrosis factor therapy. Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64.3%) and peficitinib 25, 50, 100 and 150 mg groups (70.9%, 64.9%, 52.7% and 67.2%, respectively). TEAEs occurring more frequently in the peficitinib group compared with the placebo group included nasopharyngitis, increased blood creatine phosphokinase and diarrhoea. No cases of serious infections were reported. Herpes zoster occurred in four patients (two each in peficitinib 25 and 100 mg).

conclusionsTreatment with peficitinib as monotherapy for 12 weeks in Japanese patients with moderate to severe RA is efficacious and showed acceptable safety profile. These findings support further developments of peficitinib for RA treatment. TRIAL REGISTRATION NUMBER: NCT01649999; Results.

Indexed as

AdamantaneAdultAntirheumatic AgentsArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansJanus KinasesJapanMaleMiddle AgedNiacinamideSeverity of Illness IndexTreatment OutcomeAdamantaneAntirheumatic AgentsJanus KinasesNiacinamidepeficitinibDMARDs (synthetic)Rheumatoid ArthritisTreatment

Identifiers

PMID26672064
PMCPMC4893099
OpenAlexW2200225893

What OpenQuestion holds

Textmetadata
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.