Risk of tuberculosis in children with rheumatologic diseases treated with biological agents: A cross-sectional cohort study

Abstract

Objectives: This study aimed to evaluate the risk of tuberculosis (TB) disease in children receiving biological agents for rheumatologic diseases, focusing on appropriate screening tests in a high-priority country for TB control.

Patients and methods: One hundred nine children (56 females, 53 males; range, 3.4 to 16.2 years) who received any biological agent for rheumatologic diseases for more than two years between May 2012 and October 2021 were included in this retrospective study. Patients were screened for TB infection using tuberculin skin test (TST) or interferon-gamma release assay (IGRA). Following the initial evaluation, patients were clinically examined for TB every three months by a comprehensive medical history and physical examination, and every 12 months using TST or IGRA.

Results: At the initiation of the biological agent, the patients’ mean age was 12.4±4.5 years. The average follow-up duration was 3.6±1.3 years (range, 2.6 to 10.2 years) for patients treated with biological agents. Each patient had a documented Bacillus Calmette-Guérin vaccination. Before the initiating of therapy, TST was performed alone in 45 (41.3%) patients and in combination with IGRA in 64 (58.7%) patients. In the 64 patients who underwent both TST and IGRA, IGRA revealed nine (14.1%) positive results. Six (66.7%) of these nine patients, however, had negative baseline TST. Four (7.3%) of the 55 individuals whose initial IGRA results were negative also had positive TST results. Overall, no TB disease was observed after a follow-up period.

Conclusion: This study reveals that biological agents were not associated with an increased risk of TB disease in closely monitored children. Additionally, the concomitant use of TST and IGRA for screening of TB is reasonable in patients receiving biological agents.

Citation: Bayram N, Altuğ Gücenmez Ö, Makay B, Kıymet E, Böncüoğlu E, Şahinkaya Ş, et al. Risk of tuberculosis in children with rheumatologic diseases treated with biological agents: A cross-sectional cohort study. Arch Rheumatol 2023;38(4):549-555. doi: 10.46497/ ArchRheumatol.2023.9900.

The study protocol was approved by the University of Health Sciences, Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Ethics Committee (date: 17.12.2020, no: 2020/17-09). The study was conducted in accordance with the principles of the Declaration of Helsinki.

A written informed consent was obtained from the parents of the patients.

Conceptualization and methodology: N.B., ‹.D.; Data collection: E.K., E.B., .., A.A.K., K.Ö.A., B.M., Ö.A.G.; Writing: N.B., E.B., Y.S., ‹.D.; Editing: N.B., E.K., Ö.A.G., B.M.; All authors read and approved the final manuscript.

The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

The authors received no financial support for the research and/or authorship of this article.

The data that support the findings of this study are available from the corresponding author upon reasonable request.