Evidence map›Paper›PMID 32591978›Full record

ArticleClinical drug investigation2020

Investigation of Potential Drug-Drug Interactions between Peficitinib (ASP015K) and Methotrexate in Patients with Rheumatoid Arthritis.

Tong Zhu, Selina Moy, Udaya Valluri, Ying Cao, Wenhui Zhang, Taiji Sawamoto, Vishala Chindalore, Bola Akinlade

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01754805 (A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

NCT01754805 phase1completednot on this map

A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis

TypeinterventionalSponsorAstellas Pharma IncRan2010 to 2010Enrolled15ConditionsRheumatoid ArthritisArmspeficitinib, methotrexate
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
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

8 authors at 2 institutions in 2 countries.

Tong ZhuAstellas Pharma Global Development, Northbrook, IL, USA. tong.zhu@astellas.com.
Selina MoyAstellas Research Institute of America, LLC, Northbrook, IL, USA.
Udaya ValluriAstellas Pharma Global Development, Northbrook, IL, USA.
Ying CaoAstellas Pharma Global Development, Northbrook, IL, USA.
Wenhui ZhangAstellas Pharma Global Development, Northbrook, IL, USA.
Taiji SawamotoAstellas Pharma Inc., Tsukuba, Ibaraki, Japan.
Vishala ChindalorePinnacle Research Group/Anniston Medical Clinic, Anniston, AL, USA.
Bola AkinladeAstellas Pharma Global Development, Northbrook, IL, USA.
Astellas Pharma (United States) · USAstellas Pharma (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMethotrexate is frequently used to treat rheumatoid arthritis. Peficitinib (ASP015K; Smyraf

objectiveThe objective of this study was to investigate potential drug-drug interactions of peficitinib with methotrexate and the short-term safety of coadministration. PATIENTS AND

methodsThis phase I, open-label, single-sequence study included patients with rheumatoid arthritis taking a stable dose of methotrexate. Patients received their prescribed methotrexate dose (Day 1) and then peficitinib (100 mg) twice daily from Day 3 until the morning of Day 9; a second methotrexate dose was coadministered with peficitinib on Day 8. Serial blood samples were collected for methotrexate concentration after dosing on Days 1 (methotrexate alone) and 8 (methotrexate plus peficitinib) and for peficitinib concentration after dosing on Days 7 (peficitinib alone) and 8 (methotrexate plus peficitinib). Pre-dose concentrations of peficitinib were measured (Days 3-8).

resultsPeficitinib concentrations reached steady state on Day 5. Administration of peficitinib did not result in changes to methotrexate area under the concentration-time curve from time zero to infinity or maximum observed concentration following a methotrexate dose (15-25 mg), and there was no significant effect of methotrexate (15-25 mg) on peficitinib area under the concentration-time curve within a 12-hour dosing interval. There were no new tolerability or safety signals after coadministration of peficitinib and methotrexate. One patient experienced two serious adverse events and withdrew from the study without receiving peficitinib.

conclusionsPharmacokinetic results showed no significant interactions between peficitinib and methotrexate. CLINICALTRIALS. GOV IDENTIFIER: NCT01754805.

Indexed as

AdamantaneAdultAntirheumatic AgentsArea Under CurveArthritis, RheumatoidDrug InteractionsFemaleHalf-LifeHumansMaleMethotrexateMiddle AgedNiacinamideAdamantaneAntirheumatic AgentsMethotrexateNiacinamidepeficitinib

Identifiers

PMID32591978
PMCPMC7452880
OpenAlexW3037343889

What OpenQuestion holds

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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.