Format

Send to:

Choose Destination
See comment in PubMed Commons below
Mod Rheumatol. 2013 Jul;23(4):694-704. doi: 10.1007/s10165-012-0709-7. Epub 2012 Jul 18.

Association of hepatitis B with antirheumatic drugs: a case-control study.

Author information

  • 1The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan. 0-oshima@umin.ac.jp

Abstract

BACKGROUND:

Though concern of hepatitis B virus (HBV) reactivation by antirheumatic agents has limited therapeutic opportunities in HBV-infected rheumatoid arthritis (RA) patients, the relative risks (RR) among such agents have not been clarified.

OBJECTIVE:

We compared the reporting of antirheumatic-agent-associated hepatitis B.

PATIENTS:

We assessed 92 hepatitis B cases and 98,069 controls from a population of 98,161 RA patients registered into the US Food and Drug Administration's (FDA's) adverse event database between 2004 and 2010.

MEASUREMENTS:

A reporting odds ratio (ROR), a signal suggesting a risk for hepatitis B among antirheumatic agents, was measured.

RESULTS:

Treatment with corticosteroids [ROR 2.3 (95% confidence interval 1.3-4.0)], methotrexate [4.9 (3.9-6.0)], rituximab [7.2 (5.3-9.9)], tacrolimus [4.2 (1.5-11.9)], or reporting from Japan [2.2 (1.1-4.2)] were associated with higher signal, whereas adalimumab had a lower ROR [0.2 (0.1-0.4)].

LIMITATIONS:

There are known limitations of spontaneous reporting, such as underreporting, the Weber effect, reporting bias, indication bias, and limited clinical information such as HBV status.

CONCLUSIONS:

Adalimumab's low reporting rate is most likely be due to notoriety. However, the possibility that adalimumab might suppress reactivation of HBV cannot be denied. Until the possibility is clarified in well-designed clinical studies, physicians should use adalimumab cautiously in patients with HBV.

PMID:
22802011
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Informa Healthcare
    Loading ...
    Write to the Help Desk