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Lupus, Vol. 16, No. 5, 350-354 (2007)
DOI: 10.1177/0961203307078225

Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus

K.A.M. Kuruma

Rheumatology Division, School of Medicine of São Paulo University, São Paulo, Brazil, reumato{at}usp.br

E.F. Borba

Rheumatology Division, School of Medicine of São Paulo University, São Paulo, Brazil

M.H. Lopes

Infectious Diseases Division, School of Medicine of São Paulo University, São Paulo, Brazil

J.F. de Carvalho

Rheumatology Division, School of Medicine of São Paulo University, São Paulo, Brazil

E. Bonfá

Rheumatology Division, School of Medicine of São Paulo University, São Paulo, Brazil

Hepatitis B virus (HBV) vaccination has been implicated as a potential trigger for autoimmune diseases but there are no prospective studies in lupus. We therefore assessed prospectively the safety and efficacy of immunization with recombinant DNA HBV vaccine (Euvax B®; LG Life Sciences) in systemic lupus erythematosus (SLE) patients. Twenty-eight consecutive inactive SLE patients [Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) <4], age between 18 and 50 years and negative serology for HBV, were selected. Exclusion criteria were prednisone ≥20 mg/day and immunosuppressive drugs. Clinical and laboratorial assessments were obtained at study entry and one month after the three doses. In addition, a previous one year evaluation was performed using a standard electronic protocol. The mean age was 34 ± 7.7 years and disease duration was 10.4 ± 6.7 years. An adequate seroconversion was achieved at the end of the study (93%), although a lower frequency after the first (4%) and second dose (54%) was observed. No significant change in mean SLEDAI score was detected after each dose throughout the study (0.14 ± 0.52 versus 0 versus 0.61 ± 1.66 versus 0.36 ± 1.34, P = 0.11). Reinforcing these findings, the 11% flares during vaccination was similar to the 21% observed in the previous year (P = 0.46). Furthermore, the mean prednisone dose at study entry was comparable to the end of the study (2.86 ± 3.06 versus 4.64 ± 8.25 mg/day, P = 0.32). In addition, the frequency of immunosuppressive therapy during the vaccination period (11%) was alike to the 14% observed in the previous year before entry (P = 0.66). Hepatitis B vaccination was safe in inactive SLE patients with an adequate vaccine response rate. Lupus (2007) 16, 350—354.

Key Words: efficacy • hepatitis B • safety • systemic lupus erythematosus • vaccine


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