Evidence map›Paper›PMID 26929445›Full record

Trial reportRheumatology (Oxford, England)2016

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

Vibeke Strand, Ronald F van Vollenhoven, Eun Bong Lee, Roy Fleischmann, Samuel H Zwillich, David Gruben, Tamas Koncz, Bethanie Wilkinson, Gene Wallenstein

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 7 pooled it
8.7field-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.

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

50 citing papers in PubMed, 7 syntheses or guidelines pooled it, 78 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

9 authors at 4 institutions in 3 countries.

Vibeke StrandPrivate residence, CA, USA.
Ronald F van VollenhovenDepartment of Medicine, Karolinska Institute, Stockholm, Sweden.
Eun Bong LeeDepartment of Internal Medicine, Seoul National University, Seoul, Republic of Korea.
Roy FleischmannRheumatology Department, Metroplex Clinical Research Center, Dallas, TX.
Samuel H ZwillichMedicines Development Group, Pfizer Inc, Groton, CT and.
David GrubenMedicines Development Group, Pfizer Inc, Groton, CT and.
Tamas KonczMedicines Development Group, Pfizer Inc, New York, NY, USA.
Bethanie WilkinsonMedicines Development Group, Pfizer Inc, Groton, CT and.
Gene WallensteinMedicines Development Group, Pfizer Inc, Groton, CT and gene.wallenstein@pfizer.com.
Pfizer (United States) · USKarolinska Institutet · SEMetroplex Clinical Research Center · USSeoul National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.

methodsIn this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).

resultsAt month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.

conclusionPatients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.

Indexed as

Patient Reported Outcome MeasuresAdalimumabAdultAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHumansMaleMethotrexateMiddle AgedPiperidinesPyrimidinesPyrrolesQuality of LifeSeverity of Illness IndexAdalimumabAntirheumatic AgentsMethotrexatePiperidinesPyrimidinesPyrrolestofacitinibJanus kinasepatient-reported outcomesphase 3rheumatoid arthritistofacitinib

Identifiers

PMID26929445
PMCPMC4870388
OpenAlexW2329207709

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.