Safety and efficacy of abatacept in eight rheumatoid arthritis patients with chronic hepatitis B.

OBJECTIVE

There are no previous studies on the use of abatacept in patients with chronic hepatitis B. This medical record review assessed the safety and efficacy of abatacept in 8 patients with rheumatoid arthritis (RA) and chronic hepatitis B.

METHODS

A retrospective analysis of patients with RA and chronic hepatitis B treated with abatacept was conducted. The primary outcome was the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) at each followup visit along with markers of hepatitis B reactivation, including aspartate aminotransferase, alanine aminotransferase, and hepatitis B viral load.

RESULTS

A total of 47 visit data points were recorded. The mean ± SD duration of followup of patients receiving abatacept was 19.1 ± 12.7 months (range 3-33 months). Analysis was limited to 18 months of followup (included 77% of all visits [36 of 47]). Four patients were started on antiviral prophylaxis for hepatitis B with the initiation of abatacept, while 4 patients were not. Among the 4 patients who received antiviral prophylaxis, RA improved as evidenced by a statistically significant decrease in DAS28-ESR scores, and none had reactivation of hepatitis B. In the 4 patients without antiviral prophylaxis, there was no significant decrease in the DAS28-ESR scores and all 4 experienced reactivation of hepatitis B. There were no adverse events other than the hepatitis B reactivation.

CONCLUSION

Use of abatacept in patients with RA and chronic hepatitis B appears feasible if antiviral prophylaxis for hepatitis B is given concurrently. In these patients there were no non-hepatitis-related adverse effects. These data are encouraging and should lead to initiation of controlled trials of abatacept in hepatitis B.