The investigators assessed the safety and antibody response of immunization with a recombinant DNA hepatitis B vaccine in patients with rheumatoid arthritis (RA).
Previously, HBV infection and vaccination against it have been implicated in the potential triggering or flare of some autoimmune diseases, including RA.
However, the safety of hepatitis B vaccination in patients with pre-existing RA is not known.
A total of 44 patients with RA were included in the study.
Of these, 22 received 3 doses (the second and third dose being given after 1 and 6 months) of a recombinant DNA hepatitis B vaccine (study group) and 22 did not receive the vaccine (control group).
Both groups had comparable proportions of women and similar mean age (51 years).
Clinical assessment was conducted before, and 2 and 7 months after the first immunization. It included evaluation of daytime pain with a 10 cm visual analogue scale, duration of morning stiffness, and number of tender and swollen joints.
| HBV vaccination produces antibodies in 68% of RA patients.
| Annals of the Rheumatic Diseases |
In addition, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) were measured at each visit.
A commercial enzyme linked immunosorbent assay (ELISA) test kit determined antibodies to hepatitis B surface antigen (HBsAg).
It was found that hepatitis B vaccination was not associated with an appreciable deterioration in any clinical or laboratory measure of disease.
The measures of disease activity of the patients and controls did not differ significantly during the study period.
Some 15 of the 22 patients responded to vaccination, with an antibody level against HBsAg of 10 IU/l after 7 months.
The authors discovered that lack of response was associated with older age and higher scores of daytime pain.
Dr O. Elkayam, of the Tel Aviv Medical Centre, University of Tel Aviv, concluded on behalf of fellow colleagues, "Hepatitis B vaccination is safe in RA and is found to produce antibodies in 68% of the patients."