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 Winthrop, John W. Baddley

Research output: Contribution to journalArticle

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Abstract

Introduction: We evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort. Methods: We 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) 100 IU/mL. Results were reported as the cumulative incidence of treatment episodes achieving hepatotoxicity at 3, 6 and 12 months post biologic exposure. Results: Five 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. Conclusions: Among 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.

Original languageEnglish (US)
Article number136
JournalArthritis Research and Therapy
Volume17
Issue number1
DOIs
StatePublished - May 22 2015

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Antirheumatic Agents
Veterans
Virus Diseases
Hepatitis B virus
Rheumatoid Arthritis
Cohort Studies
Retrospective Studies
Safety
Drug Therapy
Alanine Transaminase
Veterans Health
Therapeutics
United States Department of Veterans Affairs
Antibodies
DNA
Surface Antigens
Observation
Incidence
Infection
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

Safety of biologic and nonbiologic disease-modifying antirheumatic drug therapy in veterans with rheumatoid arthritis and hepatitis B virus infection : A retrospective cohort study. / Burton, Mary Jane; Curtis, Jeffrey R.; Yang, Shuo; Chen, Lang; Singh, Jasvinder A.; Mikuls, Ted R.; Winthrop, Kevin; Baddley, John W.

In: Arthritis Research and Therapy, Vol. 17, No. 1, 136, 22.05.2015.

Research output: Contribution to journalArticle

Burton, Mary Jane ; Curtis, Jeffrey R. ; Yang, Shuo ; Chen, Lang ; Singh, Jasvinder A. ; Mikuls, Ted R. ; Winthrop, Kevin ; Baddley, John W. / Safety of biologic and nonbiologic disease-modifying antirheumatic drug therapy in veterans with rheumatoid arthritis and hepatitis B virus infection : A retrospective cohort study. In: Arthritis Research and Therapy. 2015 ; Vol. 17, No. 1.
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abstract = "Introduction: We evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort. Methods: We 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) 100 IU/mL. Results were reported as the cumulative incidence of treatment episodes achieving hepatotoxicity at 3, 6 and 12 months post biologic exposure. Results: Five 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. Conclusions: Among 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.",
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AU - Burton, Mary Jane

AU - Curtis, Jeffrey R.

AU - Yang, Shuo

AU - Chen, Lang

AU - Singh, Jasvinder A.

AU - Mikuls, Ted R.

AU - Winthrop, Kevin

AU - Baddley, John W.

PY - 2015/5/22

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N2 - Introduction: We evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort. Methods: We 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) 100 IU/mL. Results were reported as the cumulative incidence of treatment episodes achieving hepatotoxicity at 3, 6 and 12 months post biologic exposure. Results: Five 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. Conclusions: Among 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.

AB - Introduction: We evaluated the safety of current treatment regimens for patients with RA and HBV in a large US cohort. Methods: We 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) 100 IU/mL. Results were reported as the cumulative incidence of treatment episodes achieving hepatotoxicity at 3, 6 and 12 months post biologic exposure. Results: Five 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. Conclusions: Among 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.

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