Evidence map›Paper›PMID 31673419›Full record

Trial reportRMD open2019

Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial.

Vibeke Strand, Eduardo Mysler, Robert J Moots, Gene V Wallenstein, Ryan DeMasi, David Gruben, Koshika Soma, Noriko Iikuni, Josef S Smolen, Roy Fleischmann

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

Trial report in RMD open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02187055 (A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT02187055 phase4completednot on this map

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2016Enrolled1,152ConditionsRhematoid ArthritisArmsTofacitinib with methotrexate, Tofacitinib without methotrexate, Adalimumab with methotrexate
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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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

10 authors at 5 institutions in 3 countries.

Vibeke StrandDivision of Immunology/Rheumatology, Stanford University, Palo Alto, California, USA.
Eduardo MyslerReumatólogo en Organización Médica de Investigación, Buenos Aires, Argentina.
Robert J MootsDepartment of Musculoskeletal Biology, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.ORCID 0000-0001-7019-6211
Gene V WallensteinPfizer Inc, Groton, Connecticut, USA.
Ryan DeMasiPfizer Inc, Collegeville, Pennsylvania, USA.
David GrubenPfizer Inc, Groton, Connecticut, USA.
Koshika SomaPfizer Inc, Groton, Connecticut, USA.
Noriko IikuniPfizer Inc, New York, New York, USA.
Josef S SmolenDivision of Rheumatology, Medical University of Vienna, Vienna, Austria.
Roy FleischmannRheumatology Division, Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-6630-1477
Pfizer (United States) · USMedical University of Vienna · ATMetroplex Clinical Research Center · USStanford University · USUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR). Methods: ORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores. Results: Substantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points. Conclusion: Treatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning. Trial registration number: NCT02187055.

Indexed as

AdalimumabArthritis, RheumatoidDrug Therapy, CombinationHumansMethotrexateMiddle AgedPiperidinesPyrimidinesPyrrolesSeverity of Illness IndexTreatment OutcomeAdalimumabMethotrexatePiperidinesPyrimidinesPyrrolestofacitinibDMARDs (biologic)DMARDs (synthetic)outcomes researchrheumatoid arthritis

Identifiers

PMID31673419
PMCPMC6802984
OpenAlexW2979131994

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.