Evidence map›Paper›PMID 32870265›Full record

ArticleInflammatory bowel diseases2021

Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management.

Bruce E Sands, Jean-Frédéric Colombel, Christina Ha, Michel Farnier, Alessandro Armuzzi, Daniel Quirk, Gary S Friedman, Kenneth Kwok, Leonardo Salese, Chinyu Su and 1 more

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT01458574 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

TypeinterventionalSponsorPfizerRan2012 to 2016Enrolled593ConditionsUlcerative ColitisArmsPlacebo, CP690,550, CP-690,550
NCT01458951 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

TypeinterventionalSponsorPfizerRan2012 to 2015Enrolled547ConditionsUlcerative ColitisArmstofacitinib, Placebo
NCT01465763 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

TypeinterventionalSponsorPfizerRan2012 to 2015Enrolled614ConditionsUlcerative ColitisArmstofacitinib, Placebo
NCT01470612 phase3completednot on this map

A multi-center, open-label study of cp-690,550 in subjects with moderate to severe ulcerative colitis

TypeinterventionalSponsorPfizerRan2012 to 2020Enrolled944ConditionsUlcerative ColitisArmsCP-690,550
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  8. [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
    Review
  9. Review
  10. Article
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  20. User's guide to JAK inhibitors in inflammatory bowel disease.Current research in pharmacology and drug discovery · 2022
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jean-Frédéric ColombelDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Christina HaInflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Michel FarnierPEC2, EA 7460, University of Bourgogne-Franche Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France.
Alessandro ArmuzziIBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
Daniel QuirkInflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Gary S FriedmanInflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Kenneth KwokInflammation & Immunology, Pfizer Inc, New York, New York, USA.
Leonardo SaleseInflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Chinyu SuInflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Pam R TaubDivision of Cardiovascular Medicine, University of California, San Diego, California, USA.
Pfizer (United States) · USIcahn School of Medicine at Mount Sinai · USCedars-Sinai Medical Center · USIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversité de Bourgogne · FRUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with ulcerative colitis (UC) are at elevated risk of cardiovascular disease vs the general population, despite a lower prevalence of traditional risk factors, including hyperlipidemia. Mechanistic studies in patients with rheumatoid arthritis and psoriasis suggest that tofacitinib restores serum lipids to preinflammation levels by reversing inflammation-induced cholesterol metabolism changes. We reviewed data on lipid levels and cardiovascular events, alongside recommendations for managing lipid levels during tofacitinib treatment in patients with UC, based on up-to-date expert guidelines.

methodsData were identified from a phase 3/open-label, long-term extension (OLE) tofacitinib UC clinical program (cutoff May 27, 2019). Literature was identified from PubMed (search terms "lipid," "cholesterol," "lipoprotein," "cardiovascular," "inflammation," "atherosclerosis," "tofacitinib," "rheumatoid arthritis," "psoriasis," "inflammatory bowel disease," "ulcerative colitis," "hyperlipidemia," and "guidelines") and author knowledge. Data were available from 4 phase 3 clinical trials of 1124 patients with moderately to severely active UC who received ≥1 dose of tofacitinib 5 or 10 mg twice daily in induction (two identical trials), maintenance, and OLE studies (treatment duration ≤6.8 years; 2576.4 patient-years of drug exposure).

resultsIn the OLE study, tofacitinib treatment was not associated with major changes from baseline in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, total cholesterol/high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol/high-density lipoprotein cholesterol, with lipid levels and ratios generally remaining stable over time. The major adverse cardiovascular events incidence rate was 0.26/100 patient-years (95% confidence interval, 0.11-0.54).

conclusionsLipid levels and ratios remained generally unchanged from baseline in the OLE study after tofacitinib treatment, and major adverse cardiovascular events were infrequent. Long-term studies are ongoing. CLINICALTRIALS.GOV IDENTIFIERS: NCT01465763, NCT01458951, NCT01458574, NCT01470612.

Indexed as

Cardiovascular DiseasesColitis, UlcerativeHeart Disease Risk FactorsArthritis, RheumatoidCholesterolClinical Trials, Phase III as TopicHumansInflammationLipidsLipoproteins, HDLLipoproteins, LDLPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesCholesterolLipidsLipoproteins, HDLLipoproteins, LDLPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibclinical trialslipidstofacitinib

Identifiers

PMID32870265
PMCPMC8128390
OpenAlexW3081791068

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.