Background/Purpose: In patients with rheumatoid arthritis (RA) concomitant hepatitis B (HBV) represents a therapeutic challenge limiting, DMARD treatment options (conventional and biologics, especially anti-TNFa and rituximab) are limited. About abatacept there are unclear and scant data confined to isolated medical records review and anecdotal case reports. This observational multicenter retrospective study was planned to verify safety of abatacept in this particular setting in a group of italian patients.

Methods: Six rheumatologic centres in different geographical areas of Italy were invited to participate in the study and provided data from patients with RA and positive HBV serology treated with abatacept in recent years. HBV serological markers, RA clinical and laboratory data were assessed by retrieving information from clinical documentation (hospital records, patient folders and clinical charts) provided by each participating centre and stored in a dedicated database. Follow-up data at 3 months intervals,  up to 24 months, were analysed. The dose of Abatacept was given according to the standard guidelines, every two weeks for the first month and then monthly.

Results: 33 patients were included, 5 male and 28 female, mean disease duration 12 ± 5 ys and  baseline active disease (average DAS28 = 5.56 ± 1.5). 22 patients (66.6%) were RF positive and 19 (57%) ACPA positive. Prior biologics were tried unsuccessfully in 15 (2 biologics) and 5 patients (3 biologics) before starting abatacept. In combination with abatacept  patients received methotrexate (18), leflunomide (4), sulphasalazine or hydroxicloroquine (1), corticosteroid alone (8). At baseline 27 patients were categorized as inactive carrier  (one of these was also anti-HCV positive) and 4 patients as occult carries (anti-core positive) for HBV.  Liver function tests were normal and HBV-DNA titer was low or undectable in all patients. Seven patients received antiviral prophylaxis, 5 with lamivudina e 1 with adefovir first and then tenofovir. In the follow-up assessment data were available in 14 patients ongoing at 12 months (DAS28 = 3.99±1.2) and in 5 patients ongoing at 24 months (DAS28 = 2.10 ±1.6) break point of follow-up. No patients experienced reactivation of hepatitis B; liver function tests remained normal and serologic HBV status remained the same as at baseline. Discontinuation of therapy was due to inefficacy (13 primary, 12 secondary), patient’s decision (2), low compliance (1), lost to follow-up (1) and adverse events (4) none of them HBV related. The high rate of withdrawal can be justified by the particular characteristics of the included patients, being long-standing refractory RA with an high rate of previous treatment failure.

Conclusion: Our study – not designed to test efficacy – shows encouraging data about safety of abatacept in patients with concomitant HBV positive serology also in patients without any antiviral prophilaxys. More prospective data are needed to confirm these preliminary results.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-abatacept-in-rheumatoid-arthritis-with-chronic-hepatitis-b-virus-infection/