Tofacitinib may promote HBV reactivation in certain RA patients

Use of tofacitinib for rheumatoid arthritis (RA) may lead to reactivation of hepatitis B virus (HBV), especially among hepatitis B surface antigen-positive (HBsAg+) and HBsAg-negative/hepatitis B core antibody-positive (HBsAg–/HBcAb+) patients, according to a study from Taiwan.

The retrospective study included 98 RA patients receiving treatment with tofacitinib for at least 3 months. All patients were followed up every 3 to 6 months to have their serum HBV DNA levels and serum alanine aminotransferase assessed for HBV reactivation.

Of the patients, eight were HBsAg+ (8.1 percent) and 64 were HBsAg−/HBcAb+ (65.3 percent). In the HBsAg+ RA group, two patients were administered antiviral prophylaxis, and none of them had HBV reactivation or hepatitis flare-up.

HBV reactivation occurred in two out of six patients in the HBsAg+ RA group who did not receive antiviral prophylaxis (33.3 percent). In the HBsAg−/HBcAb+ RA group, two patients had HBV reactivation (3.1 percent).

The corresponding incidence rate of HBV reactivation in the HBsAg+ RA group was 153.8 per 1,000 person-years overall and 250 per 1,000 person-years after excluding patients who had received antiviral prophylaxis. In the HBsAg−/HBcAb+ RA group, the incidence rate was 11.2 per 1,000 person-years.

The present data suggest that HBV reactivation occurrence following tofacitinib use is especially high in the HBsAg+ RA group, and reactivation can be avoided by antiviral prophylaxis. On the other hand, the risk of reactivation is low in the HBsAg−/HBcAb+ RA group, although close monitoring of HBV DNA and alanine aminotransferase is still recommended.