The Efficacy and Safety of Hepatitis A Vaccine in Children and Young Adults With an Autoinflammatory Diseases on Canakinumab and Tocilizumab Treatments: A Prospective Observational Controlled Study.

INTRO

In this prospective interventional study, we aimed to assess the efficacy and safety of the hepatitis A vaccine in patients with autoinflammatory diseases undergoing canakinumab and tocilizumab treatments.

METHODS

A total of 24 patients with autoinflammatory diseases on canakinumab and tocilizumab treatments and 39 healthy children who were seronegative for hepatitis A were included in the study. All participants were vaccinated with 2 doses of inactivated hepatitis A vaccine at 6-month intervals. One month after the last vaccination, venous blood samples were collected from each participant, and the anti-HAV IgM and IgG titers were measured.

RESULTS

The patient group consisted of 19 patients with systemic juvenile idiopathic arthritis (sJIA) and 5 patients with cryopyrin-associated periodic fever. The mean age of the patient group and the healthy controls were 14.1 ± 3.7 and 12.4 ± 3.2 years, respectively. All patients with cryopyrin-associated periodic fever and 52.6% (10/19) of the patients with sJIA were on canakinumab. The remaining 9 patients (47.3%) with sJIA were using tocilizumab. Among sJIA patients, 15 were also on methotrexate, and 14 were on prednisolone. All of the participants were negative for hepatitis A serology. After two doses of hepatitis A vaccine, all the patients with autoinflammatory diseases (24/24) and 84.6% (33/39) of the healthy controls were detected as positive for anti-HAV IgG (p = 0.04). The mean anti-HAV Ig G titers of the patient group and the control group one month after the last dose of vaccination were 5.25 ± 1.49 IU/L and 10.5 ± 7.02 IU/L, respectively (p < 0.001). Neither disease flares nor adverse effects related to vaccination were observed within the study period.

CONCLUSION

Hepatitis A vaccine is effective and safe in children with autoinflammatory diseases on biologic therapy. Long-term follow-up data, including larger patient cohorts, are needed to draw a solid conclusion about the safety of hepatitis A vaccine in patients receiving canakinumab and tocilizumab therapy.

© 2025 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.