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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 MJ, Curtis JR, Yang S, Chen L, Singh JA, Mikuls TR, Winthrop KL, Baddley JW - Arthritis Res. Ther. (2015)

Bottom Line: Mean age was 62.1 ± 10.3 years; 91.8% were male.The median time between HBV screening and starting a new RA drug was 504 days (IQR 144, 1,163).A total of 146 (15.2%) treatment episodes received at least one test for HBV DNA at any point in the observation period.

View Article: PubMed Central - PubMed

Affiliation: G.V. Sonny Montgomery VA Medical Center, 1500 E Woodrow Wilson Avenue, Jackson, MS, 39216, USA. Mary.burton2@va.gov.

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) <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.

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.

No MeSH data available.


Related in: MedlinePlus

Testing of HBV markers before the index date. Distribution of days (x-axis) between the testing of any HBV laboratory marker (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B e antigen, HBV DNA) prior initiation of a new DMARD (index date), stratified by the presence or absence of hepatotoxicity. (ALT>100 IU/mL). Y axis represents a probability density function that any hepatitis B laboratory marker was ordered at each time point.
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Fig2: Testing of HBV markers before the index date. Distribution of days (x-axis) between the testing of any HBV laboratory marker (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B e antigen, HBV DNA) prior initiation of a new DMARD (index date), stratified by the presence or absence of hepatotoxicity. (ALT>100 IU/mL). Y axis represents a probability density function that any hepatitis B laboratory marker was ordered at each time point.

Mentions: The median time between a preceding test for any HBV laboratory markers and DMARD initiation was 504 days (IQR 144, 1,163) (Figure 2). Following drug initiation, testing for any HBV laboratory markers occurred infrequently, with no observable difference between patients who experienced hepatotoxicity and those who did not (Figure 3). Among 26 episodes of hepatotoxicity, ordering of any HBV laboratory testing occurred in 14 cases (53.8%), at a median of 202 days (IQR 82, 716) from the date of hepatotoxicity to the date the first HBV test was ordered. In patients who did not experience hepatotoxicity, ordering of any HBV laboratory testing occurred in 342 episodes (36.7%), with a median of 494 days (IQR 162, 991) between DMARD initiation and HBV laboratory monitoring. Of the entire cohort, paired testing of HBV DNA occurred prior to DMARD initiation and during follow-up in only 35 instances (3.6%). A total of 146 (15.2%) treatment episodes received at least one test for HBV DNA at any point in the observation period.Figure 2


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 MJ, Curtis JR, Yang S, Chen L, Singh JA, Mikuls TR, Winthrop KL, Baddley JW - Arthritis Res. Ther. (2015)

Testing of HBV markers before the index date. Distribution of days (x-axis) between the testing of any HBV laboratory marker (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B e antigen, HBV DNA) prior initiation of a new DMARD (index date), stratified by the presence or absence of hepatotoxicity. (ALT>100 IU/mL). Y axis represents a probability density function that any hepatitis B laboratory marker was ordered at each time point.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4489034&req=5

Fig2: Testing of HBV markers before the index date. Distribution of days (x-axis) between the testing of any HBV laboratory marker (hepatitis B surface antigen, hepatitis B core antibody, hepatitis B e antigen, HBV DNA) prior initiation of a new DMARD (index date), stratified by the presence or absence of hepatotoxicity. (ALT>100 IU/mL). Y axis represents a probability density function that any hepatitis B laboratory marker was ordered at each time point.
Mentions: The median time between a preceding test for any HBV laboratory markers and DMARD initiation was 504 days (IQR 144, 1,163) (Figure 2). Following drug initiation, testing for any HBV laboratory markers occurred infrequently, with no observable difference between patients who experienced hepatotoxicity and those who did not (Figure 3). Among 26 episodes of hepatotoxicity, ordering of any HBV laboratory testing occurred in 14 cases (53.8%), at a median of 202 days (IQR 82, 716) from the date of hepatotoxicity to the date the first HBV test was ordered. In patients who did not experience hepatotoxicity, ordering of any HBV laboratory testing occurred in 342 episodes (36.7%), with a median of 494 days (IQR 162, 991) between DMARD initiation and HBV laboratory monitoring. Of the entire cohort, paired testing of HBV DNA occurred prior to DMARD initiation and during follow-up in only 35 instances (3.6%). A total of 146 (15.2%) treatment episodes received at least one test for HBV DNA at any point in the observation period.Figure 2

Bottom Line: Mean age was 62.1 ± 10.3 years; 91.8% were male.The median time between HBV screening and starting a new RA drug was 504 days (IQR 144, 1,163).A total of 146 (15.2%) treatment episodes received at least one test for HBV DNA at any point in the observation period.

View Article: PubMed Central - PubMed

Affiliation: G.V. Sonny Montgomery VA Medical Center, 1500 E Woodrow Wilson Avenue, Jackson, MS, 39216, USA. Mary.burton2@va.gov.

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) <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.

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.

No MeSH data available.


Related in: MedlinePlus