Evidence map›Paper›PMID 27565000›Full record

Trial reportArthritis care & research2017

Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.

Vibeke Strand, Joel M Kremer, David Gruben, Sriram Krishnaswami, Samuel H Zwillich, Gene V Wallenstein

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis care & research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
5.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 77 citations in OpenAlex.

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  19. Development of a Patient-Reported Outcome (PRO) Measure to Assess Emotional Impact of Treatment for Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  20. Development of a sensitive biochemical assay for the detection of tofacitinib adherence.Analytical methods : advancing methods and applications · 2023
    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

6 authors at 3 institutions in 1 country.

Vibeke StrandStanford University School of Medicine, Palo Alto, California.
Joel M KremerAlbany Medical College, Albany, New York.
David GrubenPfizer Inc, Groton, Connecticut.
Sriram KrishnaswamiPfizer Inc, Groton, Connecticut.
Samuel H ZwillichPfizer Inc, Groton, Connecticut.
Gene V WallensteinPfizer Inc, Groton, Connecticut.
Pfizer (United States) · USAlbany Medical Center Hospital · USPalo Alto University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs).

methodsIn a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]).

resultsAt month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID).

conclusionPatients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo.

Indexed as

Patient Reported Outcome MeasuresAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolesRecovery of FunctionRemission InductionTime FactorsAntirheumatic AgentsPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID27565000
PMCPMC5413813
OpenAlexW2512318275

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.