Evaluation of the efficacy of various hepatitis B dosage regimens in spondyloarthritis patients undergoing immunomodulatory treatment.

OBJECTIVE

To assess the serologic response to different double-dose hepatitis B vaccination protocols in patients with axial spondyloarthritis receiving biologic therapy.

MATERIALS AND

METHODS

This single-center, retrospective study included patients diagnosed with axial spondyloarthritis (axSpA) according to ASAS classification criteria. Patients receiving biologic therapy who were non-immune to hepatitis B virus were vaccinated with double-dose hepatitis B vaccine (40 µg) using one of three different vaccination schedules: 0-1-6 months, 0-1-2-12 months, or 0-7-21-365 days. A reference group of axSpA patients treated with nonsteroidal anti-inflammatory drugs and/or conventional DMARDs received the standard-dose hepatitis B vaccine (20 µg) according to the conventional schedule. Anti-hepatitis B surface antibody (anti-HBs) levels were measured one month after completion of vaccination, and an anti-HBs level ≥ 10 IU/L was considered indicative of a protective immune response.

RESULTS

Among 103 biologic-treated patients with axSpA, 91 patients (88.3%) achieved a protective anti-HBs response following double-dose hepatitis B vaccination, while 12 patients (11.7%) were classified as non-responders. Serologic response rates did not differ significantly among the three double-dose vaccination protocols. In bivariate analyses, non-response was more frequently observed in patients receiving infliximab and certolizumab pegol; however, no independent predictors of non-response were identified in multivariate logistic regression analysis. All patients in the reference group, consisting of biologic-naïve axSpA patients, achieved protective anti-HBs titers following standard-dose hepatitis B vaccination.

CONCLUSION

Double-dose hepatitis B vaccination is associated with high serologic response rates in patients with axial spondyloarthritis receiving biologic therapy, regardless of the vaccination schedule applied. These findings support the use of intensified hepatitis B vaccination strategies in axSpA patients undergoing biologic treatment. Key Points • In biologic-treated axial spondyloarthritis patients, double-dose (40 µg) hepatitis B vaccination achieved a high seroprotection rate of 88.3%. • Similar immune responses across vaccination schedules indicate that antigen dose, rather than timing, is the main determinant of seroprotection.