Evidence map›Paper›PMID 26001631›Full record

ArticleArthritis research & therapy2015

Safety of biologic and nonbiologic disease-modifying antirheumatic drug therapy in veterans with rheumatoid arthritis and hepatitis B virus infection: a retrospective cohort study.

Mary Jane Burton, Jeffrey R Curtis, Shuo Yang, Lang Chen, Jasvinder A Singh, Ted R Mikuls, Kevin L Winthrop, John W Baddley

Abstract read
In one paragraph

Article in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Article
  4. Article
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.

Mary Jane BurtonG.V. Sonny Montgomery VA Medical Center, 1500 E Woodrow Wilson Avenue, Jackson, MS, 39216, USA. Mary.burton2@va.gov.
Jeffrey R CurtisBirmingham VAMC, 700 19th Street S, Birmingham, AL, 35233, USA. jcurtis@uab.edu.
Shuo YangBirmingham VAMC, 700 19th Street S, Birmingham, AL, 35233, USA. shouyang@uab.edu.
Lang ChenBirmingham VAMC, 700 19th Street S, Birmingham, AL, 35233, USA. langchen@uab.edu.
Jasvinder A SinghBirmingham VAMC, 700 19th Street S, Birmingham, AL, 35233, USA. jassingh@uab.edu.
Ted R MikulsOmaha VAMC; UNMC, 4101 Woolworth Avenue, Omaha, NE, 68105, USA. tmikuls@unmc.edu.
Kevin L WinthropOregon Health Sciences University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA. winthrop@ohsu.edu.
John W BaddleyBirmingham VAMC, 700 19th Street S, Birmingham, AL, 35233, USA. jbaddley@uab.edu.

Funding

Multicenter Osteoarthritis Study (MOST) Second Renewal - UAB Clinical CenterU01AG018947 · NIA · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI LEWIS, CORA E · 2001 to 2020
$13.2M
The Effects of Urate Lowering Therapy on Inflammation, Endothelial function, andP50AR060772 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, KENNETH G · 2012 to 2021
$12.8M
UAB Deep South Arthritis and Musculoskeletal CERTsU19HS021110 · AHRQ · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, KENNETH G · 2011 to 2015
$4.1M
ACOSOG Community Clinical Oncology Program (CCOP) Research BaseU10CA149950 · NCI · MAYO CLINIC ROCHESTER · PI NELSON, HEIDI, SLOAN, JEFF A. · 2011 to 2014
$3.9M
Longitudinal Comparative Effectiveness & Safety of Biologics in AutoimmunityR01HS018517 · AHRQ · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CURTIS, JEFFREY R. · 2009 to 2013
$2.2M
Effectiveness of DiscontinuinG bisphosphonatEs Study (EDGE)U34AR062891 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, KENNETH G · 2013 to 2014
$647k
AHRQ HHS R01 HS018517AHRQ HHS U19 HS021110NCI NIH HHS U10 CA149950NIAMS NIH HHS P50 AR060772NIAMS NIH HHS U34 AR062891NIA NIH HHS U01 AG018947
6 · The paper itself

Abstract

introductionWe evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort.

methodsWe identified biologic and nonbiologic treatment episodes of RA patients using 1997 to 2011 national data from the US Veterans Health Administration. Eligible episodes had evidence of HBV infection (HBV surface antigen, HBV core antibody, HBV e-antibody and/or HBV DNA) and had a baseline alanine aminotransferase (ALT) <1.5 times the upper limit of laboratory normal within 90 days prior to initiation of a new biologic or nonbiologic DMARD. The main outcome of interest was hepatotoxicity, defined as ALT elevation >100 IU/mL. Results were reported as the cumulative incidence of treatment episodes achieving hepatotoxicity at 3, 6 and 12 months post biologic exposure.

resultsFive hundred sixty-six unique RA patients with HBV contributed 959 treatment episodes. Mean age was 62.1 ± 10.3 years; 91.8% were male. Hepatotoxicity was uncommon, with 26 events identified among 959 episodes (2.7%) within 12 months. Hepatotoxicity was comparable between biologic and nonbiologic DMARDs (2.6% vs. 2.8%, P = 0.87). The median time between HBV screening and starting a new RA drug was 504 days (IQR 144, 1,163). Follow-up HBV testing occurred among 14 hepatotoxicity episodes (53.8%) at a median of 202 days (IQR 82, 716) from the date of ALT elevation. A total of 146 (15.2%) treatment episodes received at least one test for HBV DNA at any point in the observation period.

conclusionsAmong US veterans with RA and HBV the risk of hepatotoxicity is low (2.7%), and comparable between biologic and nonbiologic DMARDS (2.8% vs. 2.6%, P = 0.87). HBV testing associated with DMARD initiation or hepatotoxicity was infrequent.

Indexed as

AgedAntirheumatic AgentsArthritis, RheumatoidChemical and Drug Induced Liver InjuryCohort StudiesFemaleHepatitis BHumansIncidenceMaleMiddle AgedRetrospective StudiesVeteransAntirheumatic Agents

Identifiers

PMID26001631
PMCPMC4489034

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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.