Safety of abatacept in rheumatoid arthritis with serological evidence of past or present hepatitis B virus infection.

OBJECTIVE: Rheumatoid arthritis (RA) with concomitant hepatitis B virus (HBV) infection represents a therapeutic challenge due to the risk of HBV reactivation under immunosuppressive treatment. To date there are few data concerning the HBV reactivation following treatment with abatacept coming from anecdotal case reports. This observational retrospective study was aimed to assess the safety profile of abatacept in this particular clinical setting. METHODS: Eleven Italian rheumatologic centres provided data from patients with RA and positive HBV serology treated with intravenously abatacept. HBV markers, clinical and laboratory data were checked at follow up visits every 3 months. RESULTS: In total 72 patients were included in the study, 47 inactive carrier, 21 occult carries and 4 chronic active carriers for HBV. At baseline all of the patients had normal liver function tests and low or undetectable HBV DNA levels except for those with chronic active hepatitis. 13 patients received prophylaxis with lamivudine and 4 treatment with adefovir or tenofovir. At the end of 24 months period of follow up, 49 patients were being treated. Data from 316 follow up visits showed that abatacept was safe. No patients experienced reactivation of hepatitis B. Treatment withdrawals (23 patients) were due to lack of efficacy, subject decision/lost at follow up or adverse events not related to HBV infection. CONCLUSIONS: Our study provides reassuring data about the safety profile of abatacept in RA with concomitant HBV infection also without universal antiviral prophilaxys. Further prospective studies are needed to confirm these preliminary results. This article is protected by copyright. All rights reserved.