Evidence map›Paper›PMID 30075534›Full record

Trial reportMedicine2018

Tofacitinib, an oral Janus kinase inhibitor, in patients from Brazil with rheumatoid arthritis: Pooled efficacy and safety analyses.

Andrea B V Lomonte, Sebastião C Radominski, Flora M D Marcolino, Claiton V Brenol, Cristiano A F Zerbini, Erika G García, Ermeg L Akylbekova, Ricardo Rojo, Dario Ponce de Leon

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Observational
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.

Andrea B V LomonteCentro Paulista de Investigação Clínica, São Paulo Universidade Federal do Paraná, Curitiba Faculdade de Medicina da Universidade de São Paulo, São Paulo Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil Pfizer Inc, Collegeville, PA IQVIA, Durham, NC Pfizer Inc, Groton, CT Pfizer Inc, Lima, Peru.
Sebastião C Radominski
Flora M D Marcolino
Claiton V Brenol
Cristiano A F Zerbini
Erika G García
Ermeg L Akylbekova
Ricardo Rojo
Dario Ponce de Leon

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Efficacy and safety of tofacitinib in Brazilian patients from Phase 2 (P2) and Phase 3 (P3) global studies of up to 24 months' duration were evaluated.

methodsData were pooled from Brazilian patients with RA and an inadequate response to conventional synthetic or biologic disease-modifying antirheumatic drugs enrolled in P2/P3 tofacitinib studies who received tofacitinib 5 or 10 mg twice daily (BID), or placebo, as monotherapy or in combination with methotrexate. Efficacy, safety, and patient-reported outcomes were assessed over 24 months.

resultsPatients (226) from Brazil were treated in tofacitinib global P2/P3 studies. At Month 3, there were improvements in American College of Rheumatology 20/50/70 response rates, Disease Activity Score in 28 joints, erythrocyte sedimentation rate, and Health Assessment Questionnaire-Disability Index scores with both tofacitinib doses. Improvements from baseline in pain, fatigue, and health-related quality of life with tofacitinib 5 and 10 mg BID were reported. Efficacy improvements were sustained up to Month 24. The most frequent class of adverse events was infections and infestations. No cases of tuberculosis or other opportunistic infections were reported.

conclusionIn a Brazilian subpopulation of patients with RA, tofacitinib reduced disease signs and symptoms and improved physical function up to Month 24, with a safety profile consistent with findings from global studies.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationBrazilDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansJanus Kinase InhibitorsMaleMethotrexateMiddle AgedPatient Reported Outcome MeasuresPiperidinesAntirheumatic AgentsJanus Kinase InhibitorsMethotrexatePiperidinesPyrimidinesPyrrolestofacitinib

Identifiers

PMID30075534
PMCPMC6081087

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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.