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

Arthritis Care Res (Hoboken). 2012 Aug;64(8):1265-8. doi: 10.1002/acr.21654.

Abstract

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.

MeSH terms

  • Abatacept
  • Aged
  • Antirheumatic Agents / administration & dosage*
  • Antirheumatic Agents / adverse effects
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Arthritis, Rheumatoid / complications*
  • Arthritis, Rheumatoid / drug therapy*
  • Comorbidity
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Hepatitis B, Chronic / complications*
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Immunoconjugates / administration & dosage*
  • Immunoconjugates / adverse effects
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors

Substances

  • Antirheumatic Agents
  • Antiviral Agents
  • Immunoconjugates
  • Tumor Necrosis Factor-alpha
  • Abatacept