The goals of this trial were to evaluate the effectiveness and safety of hepatitis B vaccination in patients with rheumatoid arthritis (RA) who were on conventional and/or biological disease-modifying antirheumatic medicines (DMARDs). A longitudinal open-label investigation was carried out. Of the 46 RA patients, 33 got just conventional synthetic DMARDs, 13 received both conventional synthetic DMARDs and biological DMARDs, and 9 healthy age- and sex-matched control individuals were immunized at weeks 0, 4, and 24 with 20 g recombinant hepatitis B vaccine. Surface antibody levels for Hepatitis B were evaluated 8 weeks following the last dose of immunization. A hepatitis B surface antibody titer of 10 mIU/mL or above was considered to be seroprotective. At each visit, adverse occurrences were noted. Seroprotection in RA patients was lower than in controls. When compared to the control group, patients on biological and conventional DMARDs showed a lower proportion of seroprotection. Responders were younger than nonresponders among RA patients, with mean ages of 57.5 and 64.9 years, respectively, and were less likely to be treated with rituximab. The Hepatitis B vaccine was generally well tolerated. The risk of RA flare-up did not increase following hepatitis B immunization.

When compared to control participants, patients with RA on DMARDs showed a lower humoral response to hepatitis B immunization. Aging and the use of rituximab were linked to a poor response to hepatitis B immunization. In RA patients, the hepatitis B vaccine is safe and well-tolerated.