Evidence map›Paper›PMID 27002108›Full record

Trial reportAnnals of the rheumatic diseases2016

Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques.

Philip G Conaghan, Mikkel Østergaard, Michael A Bowes, Chunying Wu, Thomas Fuerst, Désirée van der Heijde, Fedra Irazoque-Palazuelos, Oscar Soto-Raices, Pawel Hrycaj, Zhiyong Xie and 5 more

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 NCT01164579 (An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib), which is not on this map. Cited by 58 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 7 pooled it
14.4field-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.

NCT01164579 phase2completednot on this map

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled109ConditionsRheumatoid ArthritisArmsTasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, Placebo tofacitinib plus Methotrexate
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 7 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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  5. Efficacy of methotrexate in reducing the risk of bone erosion in patients with rheumatoid arthritis: a systematic review of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
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  18. Effect ofFrontiers in pharmacology · 2024
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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

15 authors at 6 institutions in 5 countries.

Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.
Mikkel ØstergaardCopenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Michael A BowesImorphics Ltd, Manchester, UK.
Chunying WuBioClinica Inc., Newark, California, USA.
Thomas FuerstBioClinica Inc., Newark, California, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Fedra Irazoque-PalazuelosCentro de Investigación y Tratamiento Reumatológico SC.CINTRE, México City, México.
Oscar Soto-RaicesMindful Rheumatix, San Juan, Puerto Rico.
Pawel HrycajDepartment of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland.
Zhiyong XiePfizer Inc, Groton, Connecticut, USA.
Richard ZhangPfizer Inc, Groton, Connecticut, USA.
Bradley T WymanPfizer Inc, Groton, Connecticut, USA.
John D BradleyPfizer Inc, Groton, Connecticut, USA.
Koshika SomaPfizer Inc, Groton, Connecticut, USA.
Bethanie WilkinsonPfizer Inc, Groton, Connecticut, USA.
Pfizer (United States) · USBioClinica (United States) · USLeiden University Medical Center · NLPoznan University of Medical Sciences · PLUniversity of Copenhagen · DKUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo explore the effects of tofacitinib-an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)-with or without methotrexate (MTX), on MRI endpoints in MTX-naive adult patients with early active RA and synovitis in an index wrist or hand.

methodsIn this exploratory, phase 2, randomised, double-blind, parallel-group study, patients received tofacitinib 10 mg twice daily + MTX, tofacitinib 10 mg twice daily + placebo (tofacitinib monotherapy), or MTX + placebo (MTX monotherapy), for 1 year. MRI endpoints (Outcome Measures in Rheumatology Clinical Trials RA MRI score (RAMRIS), quantitative RAMRIS (RAMRIQ) and dynamic contrast-enhanced (DCE) MRI) were assessed using a mixed-effect model for repeated measures. Treatment differences with p<0.05 (vs MTX monotherapy) were considered significant.

resultsIn total, 109 patients were randomised and treated. Treatment differences in RAMRIS bone marrow oedema (BME) at month 6 were -1.55 (90% CI -2.52 to -0.58) for tofacitinib + MTX and -1.74 (-2.72 to -0.76) for tofacitinib monotherapy (both p<0.01 vs MTX monotherapy). Numerical improvements in RAMRIS synovitis at month 3 were -0.63 (-1.58 to 0.31) for tofacitinib + MTX and -0.52 (-1.46 to 0.41) for tofacitinib monotherapy (both p>0.05 vs MTX monotherapy). Treatment differences in RAMRIQ synovitis were statistically significant at month 3, consistent with DCE MRI findings. Less deterioration of RAMRIS and RAMRIQ erosive damage was seen at months 6 and 12 in both tofacitinib groups versus MTX monotherapy.

conclusionsThese results provide consistent evidence using three different MRI technologies that tofacitinib treatment leads to early reduction of inflammation and inhibits progression of structural damage. TRIAL REGISTRATION NUMBER: NCT01164579.

Indexed as

Magnetic Resonance ImagingAdultAntirheumatic AgentsArthritis, RheumatoidBone DensityBone MarrowBone Marrow DiseasesDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationEdemaFemaleHandHumansMaleMethotrexateAntirheumatic AgentsMethotrexatePiperidinesPyrimidinesPyrrolestofacitinibDMARDs (synthetic)InflammationMagnetic Resonance ImagingMethotrexateRheumatoid Arthritis

Identifiers

PMID27002108
PMCPMC4893111
OpenAlexW2254470680

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.