There is currently no experience with MabThera in patients with RA with
previous hepatitis B.
Based on reported reactivation of hepatitis B in patients with NHL, the US
package insert recommends the screening of patients with a high risk of
hepatitis B infection before starting treatment. Of note, the American College
of Rheumatology also recommends screening patients with RA for hepatitis prior
to MabThera initiation.
In RA clinical trials, no case of hepatitis B reactivation has been observed,
however patients were pre-screened for HBV. One patient with RA developed a de
novo hepatitis B infection 4 months after administration of the first dose of
MabThera. This resolved without complication following treatment with
lamivudine.
In the oncology setting, while both the underlying disease and the concomitant
chemotherapy are confounding factors, very rare cases of hepatitis B
reactivation (including reports of fulminant hepatitis) have been reported in
patients treated with MabThera; the majority of these patients were also
receiving chemotherapy.
References: ACR
hotline, May 2006; Rituxan
Prescribing Information