Session Title: Infection Related Rheumatic Diseases
Session Type: Abstract Submissions (ACR)
B cell-targeted therapy using rituximab (RTX), anti-CD20 monoclonal antibody, is an effective treatment for Rheumatoid arthritis (RA). However, the safety of such therapy in hepatitis B surface antigen (HBsAg) negative/anti-hepatitis B core antigen (anti-HBc) positive recipients is unknown. The aim of this study is to evaluate the risk of HBsAg seroreversion in this kind of patients.
We retrospectively reviewed 306 patients of our multicentre database affected by RA and treated with RTX from August 2006 to December 2011 in 5 italian outpatient rheumatologic Clinics. Complete serological screening for HBV status before the first administration of RTX and adequate post-treatment follow-up were available in 35 HBsAg negative/anti-HBc positive patients who did not undergo antiviral prophylaxis with Lamivudine. All patients (75% female, median age 60 years, median disease duration 8 yrs, 100% serum HBV DNA negative by sensitive PCR assay, 87% anti-HBs positive) has been treated with one or more disease-modifying anti-rheumatic drugs (83% MTX, 26% CYS, 80% PDN, 8% LEF, 6% AZA) and were eligible for RTX therapy according to the international guidelines. RTX was administered for a median of 3 cycles (range: 1-8) and was ongoing in 76% of cases. Clinical and laboratory examinations, including serum HBsAg and serum HBV DNA were assessed every 6 months or in case of alanine aminotransferase (ALT) elevation and at the end of the follow-up period.
During a median follow-up of 45 months (range: 12-80) 27% of patients had anti-HBs titer reduction (2 patient with a complete lost of anti-HBs levels). All patients remained viremic free except one (3%) who had an increase of serum HBV DNA (from undetectable to 24 and 44 IU/mL, 1 week apart) not associated to either HBsAg seroreversion or ALT increase. The mild virological breakthrough occurred 5 months after the first RTX administration and required Lamivudine treatment which successfully suppressed viral replication. Another patient (3%) had an ALT flare which was not related to HBV reactivation.
Conclusion: A retrospectively review of our multicentre experience suggest that in RA patients HBsAg negative/anti-HBc positive treated with RTX, Lamivudine prophylaxis should be avoid using an adequate monitoring of HBsAg or HBV DNA levels.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/low-risk-of-hepatitis-b-virus-surface-antigen-seroreversion-in-hbsag-negativeanti-hbc-positive-carriers-undergoing-rituximab-for-rheumatoid-arthritis/