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Risk of hepatitis B reactivation low in patients with RA treated with rituximab
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Patients with rheumatoid arthritis and resolved hepatitis B virus infection who underwent treatment with rituximab did not experience reactivation of the infection, according to results of a multicenter Italian study.
Researchers retrospectively studied data from 306 consecutive patients with rheumatoid arthritis (RA) who received treatment with rituximab (Rituxan, Genentech/Biogen Idec). Complete serological screening for prior infection with hepatitis B virus (HBV) was available for 216 patients and included tests for negativity to the hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antigen (anti-HBc), anti-hepatitis B envelope antigen (anti-HBe) and serum HBV DNA prior to treatment with rituximab. Thirty-nine patients (18%) were negative for HBsAg and positive for anti-HBc, six of whom received prior treatment with lamivudine and were excluded. Twenty-eight patients had protective anti-HBs titers and two had chronic hepatitis C virus infections at baseline.
Patients received at least three injections of 1,000-mg rituximab on day 1 and day 15 every 6 months and were followed with clinical and laboratory examinations, including measurements of serum HBsAg and HBV DNA.
No patients had reactivation of HBV or seroreversion of HBsAg during the median 34 months of rituximab treatment, but a decrease of more than 50% of anti-HBs levels occurred in 21% of patients, two of whom became negative for anti-HBs. Low serum HBV DNA was detected in one anti-HBe-negative patient at 6 months following initiation of rituximab without seroreversion of HBsAg or an increase in alanine transferase (ALT) and was successfully treated with lamivudine. Four of 29 patients with normal ALT levels at baseline had an increase above the upper limit of normal. The effects were transient in three patients while one patient experienced the increased levels until rituximab was discontinued. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
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