Background/Purpose:

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.

Methods:

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.

Results:

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/