Evidence map›Paper›PMID 27113415›Full record

ArticleAnnals of the rheumatic diseases2016

Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis.

Jeffrey R Curtis, Fenglong Xie, Huifeng Yun, Sasha Bernatsky, Kevin L Winthrop

Registry-linked trialOpen access · bronzeAbstract readComparative Study
In one paragraph

Article in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03016884 (Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation), which is not on this map. Cited by 114 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 6 pooled it
21.2field-weighted citation impact, top 1% 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.

NCT03016884 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation

TypeinterventionalSponsorHaEmek Medical Center, IsraelRan2017 to 2020Enrolled87ConditionsHerpes ZosterArmsZostavax vaccine
3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 6 syntheses or guidelines pooled it, 283 citations in OpenAlex.

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  19. Neutrophil diversity and function in health and disease.Signal transduction and targeted therapy · 2024
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54 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 2 countries.

Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Fenglong XieDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Huifeng YunDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Sasha BernatskyDivision of Clinical Epidemiology McGill University Health Centre, Montreal, Quebec, Canada.
Kevin L WinthropDivisions of Infectious Diseases, Public Health, and Preventive Medicine, Oregon Health & Science University, Portland, Oregon, USA.
University of Alabama at Birmingham · USMcGill University Health Centre · CAOregon Health & Science University · US

Funding

Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)UM1AR065705 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CURTIS, JEFFREY R., WINTHROP, KEVIN LORING · 2014 to 2019
$3.1M
NIAMS NIH HHS UM1 AR065705
6 · The paper itself

Abstract

objectiveTo evaluate the risks of herpes zoster (HZ) and herpes simplex virus (HSV) infection associated with tofacitinib compared with biologic agents among patients with rheumatoid arthritis (RA).

methodsUsing health plan data from 2010 to 2014, patients with RA initiating tofacitinib or biologics with no history of HZ or HSV were identified, as were incident cases of HZ or HSV. Crude incidence rates were calculated by drug exposure. Cox proportional hazards models evaluated the adjusted association between tofacitinib and HZ, and a composite outcome of HZ or HSV.

resultsA total of 2526 patients initiating tofacitinib were compared with initiations of other biologics: anti-tumour necrosis factor (TNF) (n=42 850), abatacept (n=12 305), rituximab (n=5078) and tocilizumab (n=6967). Patients receiving tofacitinib were somewhat younger (mean age 55 years) versus those on other biologics, and somewhat less likely to use concomitant methotrexate (MTX) (39% vs 43%-56%, depending on drug). Crude incidence of HZ associated with tofacitinib was 3.87/100 patient-years (py). After multivariable adjustment, HZ risk was significantly elevated, HR 2.01 (95% CI 1.40 to 2.88) compared with abatacept. Rates and adjusted HRs for all other RA biologics were comparable with each other and abatacept. Older age, female sex, prednisone >7.5 mg/day, prior outpatient infection and greater number of hospitalisations were also associated with increased HZ risk. Incidence rates for the combined outcome were greatest for tofacitinib (7.61/100 py) and also significantly elevated after adjustment (HR=1.40, 95% CI 1.09 to 1.81).

conclusionsThe rate of zoster associated with tofacitinib was approximately double that observed in patients using biologics.

Indexed as

AdultAgedAge FactorsAntirheumatic AgentsArthritis, RheumatoidBiological ProductsFemaleHerpes SimplexHerpesviridae InfectionsHerpes ZosterHumansIncidenceMaleMiddle AgedPiperidinesProportional Hazards ModelsAntirheumatic AgentsBiological ProductsPiperidinesPyrimidinesPyrrolestofacitinibInfectionsRheumatoid ArthritisVaccination

Identifiers

PMID27113415
PMCPMC5553444
OpenAlexW2343866616

What OpenQuestion holds

Textmetadata
LicenceTDM
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.