Evidence map›Paper›PMID 31385441›Full record

ArticleArthritis & rheumatology (Hoboken, N.J.)2019

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long-Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis.

Christina Charles-Schoeman, Ryan DeMasi, Hernan Valdez, Koshika Soma, Lie-Ju Hwang, Mary G Boy, Pinaki Biswas, Iain B McInnes

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in Arthritis & rheumatology (Hoboken, N.J.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
7.0field-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

44 citing papers in PubMed, 73 citations in OpenAlex.

  1. Trial
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  3. Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025
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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

8 authors at 3 institutions in 2 countries.

Christina Charles-SchoemanUniversity of California, Los Angeles.
Ryan DeMasiPfizer Inc, Collegeville, Pennsylvania.
Hernan ValdezPfizer Inc, New York, New York.
Koshika SomaPfizer Inc, Groton, Connecticut.
Lie-Ju HwangPfizer Inc, New York, New York.
Mary G BoyPfizer Inc, Groton, Connecticut.
Pinaki BiswasPfizer Inc, New York, New York.
Iain B McInnesUniversity of Glasgow, Glasgow, UK.
Pfizer (United States) · USUniversity of California, Los Angeles · USUniversity of Glasgow · GB

Funding

Mechanisms Linking Joint Inflammation and Atherosclerosis in Rheumatoid ArthritisR01HL123064 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHARLES-SCHOEMAN, CHRISTINA · 2015 to 2019
$2.7M
NHLBI NIH HHS R01 HL123064Pfizer Inc
6 · The paper itself

Abstract

objectiveTofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). This study was undertaken to evaluate the risk of major adverse cardiovascular events (MACE) in patients with RA receiving tofacitinib.

methodsData were pooled from patients with moderately to severely active RA receiving ≥1 tofacitinib dose in 6 phase III and 2 long-term extension studies over 7 years. MACE (myocardial infarction, stroke, cardiovascular death) were independently adjudicated. Cox regression models were used to evaluate associations between baseline variables and time to first MACE. Following 24 weeks of tofacitinib, changes in variables and time to future MACE were evaluated after adjusment for age, baseline values, and time-varying tofacitinib dose. Hazard ratios and 95% confidence intervals were calculated.

resultsFifty-two MACE occurred in 4,076 patients over 12,873 patient-years of exposure (incidence rate 0.4 patients with events per 100 patient-years). In univariable analyses of baseline variables, traditional cardiovascular risk factors and glucocorticoid and statin use were associated with MACE risk; disease activity and inflammation measures were not. In subsequent multivariable analyses, baseline age, hypertension, and the total cholesterol to high-density lipoprotein (HDL) cholesterol ratio remained significantly associated with risk of MACE. After 24 weeks of treatment, an increase in HDL cholesterol and a decrease in the total to HDL cholesterol were associated with decreased MACE risk; changes in total cholesterol, low-density lipoprotein (LDL) cholesterol, and disease activity measures were not. Increased erythrocyte sedimentation rates trended with increased future MACE risk.

conclusionIn this post hoc analysis, after 24 weeks of tofacitinib treatment, increased HDL cholesterol, but not increased LDL cholesterol or total cholesterol, appeared to be associated with lower future MACE risk. Further data are needed to test the cardiovascular safety of tofacitinib.

Indexed as

AgedArthritis, RheumatoidBlood SedimentationCardiovascular DiseasesCholesterolCholesterol, HDLCholesterol, LDLClinical Trials, Phase III as TopicFemaleHumansIncidenceMaleMiddle AgedMyocardial InfarctionPiperidinesProportional Hazards ModelsCholesterolCholesterol, HDLCholesterol, LDLPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID31385441
PMCPMC6754249
OpenAlexW2937337452

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.