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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0628-z) contains supplementary material, which is available to authorized users.
Highlights
We evaluated the safety of current treatment regimens for patients with rheumatoid arthritis (RA) and hepatitis B virus (HBV) in a large US cohort
Biologic agents and oral glucocorticoids alter host immune responses to HBV infection, which may increase HBV replication with resultant hepatocyte necrosis, a clinical phenomenon known as HBV
Eligible patients qualified to be in the cohort after they had at least one diagnosis of RA (International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code: 714.X) from a rheumatology provider between October 1, 1997 and December 31, 2011 and a prescription for at least one biologic or nonbiologic disease-modifying antirheumatic drug (DMARD) between October 1, 2001 and September 30, 2011
Summary
We evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort. Treatment for rheumatoid arthritis (RA) may present unique risks to patients who are chronically infected with hepatitis B virus (HBV). Biologic agents and oral glucocorticoids alter host immune responses to HBV infection, which may increase HBV replication with resultant hepatocyte necrosis, a clinical phenomenon known as HBV. The sparse literature regarding the safety of current treatments for RA in patients with HBV yields conflicting results. Several case reports document fulminant hepatic failure in RA patients with HBV who were prescribed biologic agents, as well as in patients prescribed traditional disease-modifying antirheumatic drugs (DMARDs) [4,5,6]. Small prospective Asian studies demonstrate increased risk for HBV reactivation with
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