Safety of genetically engineered biological drugs in patients with immune-inflammatory rheumatological diseases in relation to tuberculosis infection: data from a retrospective study
Panova E.A., Mordyk A.V., Bagisheva N.V., Arbuzova Yu.V.
Background: Patients with rheumatological diseases receiving genetically engineered biological drugs (GEBD) are more likely to develop tuberculosis infection than individuals with immune-inflammatory diseases receiving other treatment options.
Objective: Determination of the incidence of tuberculosis infection in rheumatological patients receiving genetically engineered biological therapy (GEBT), depending on the type of drug.
Materials and methods: A retrospective analysis of 306 outpatient records of patients receiving therapy in 2020–2025 was conducted. The median age was Me (25; 75) 52 (40; 61) years; 140 men and 166 women. Diagnostic examination included immunological tests, chest x-rays, chest multislice computed tomography (CHMSCT), sputum analysis, and other laboratory tests when indicated. Descriptive statistics and nonparametric analysis were used to process the data.
Results: Tuberculosis infection (TI) was diagnosed in 15 of 306 patients (4.9% [95% CI: 3.0–7.9%]). The highest proportion of TI cases was observed among patients receiving JAK inhibitors (10.4%). This indicator was 5.6% for TNF-α inhibitors, 3.3% for IL-17A inhibitors, and 1.5% for IL-6 inhibitors. No statistically significant differences were found between the development of TI and the class of the drug used, gender, or age category of patients. All patients diagnosed with TI were prescribed preventive anti-tuberculosis therapy. Cases of active tuberculosis were not registered in the study group.
Conclusion: Among rheumatological patients receiving GIBT, the incidence of tuberculosis infection was 4.9%. The differences identified between therapeutic subgroups are descriptive in nature and require further verification in studies with a larger sample size.
For citations: Panova E.A., Mordyk A.V., Bagisheva N.V., Arbuzova Yu.V. Safety of genetically engineered biological drugs in patients with immune-inflammatory rheumatological diseases in relation to tuberculosis infection: data from a retrospective study. Pharmateca. 2026;33(6):125-130. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.6.125-130
Authors’ contribution: Study concept and design – E.A. Panova, A.V. Mordyk. Data collection and processing – Yu.V. Arbuzova, E.A. Panova. Statistical analtsis – E.A. Panova. Writing – E.A. Panova, N.V. Bagisheva. Analysis of the material, editing, and approval of the final version of the article – N.V. Bagisheva, A.V. Mordyk.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The study was conducted without any sponsorship.
Patient Consent for Publication: The retrospective design of the study did not require informed consent from patients for statistical processing of anonymized data for subsequent publication.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
Keywords
tuberculosis infection
rheumatological diseases
genetically engineered biological therapy
risk factors
About the Authors
Elizaveta A. Panova, Applicant at the Department of Phthisiology, Pulmonology, and Infectious Diseases, Omsk State Medical University; General Practitioner, City Polyclinic No. 3, Omsk, Russia; elis-panova@yandex.ru (corresponding author)Anna V. Mordyk, Dr. Sci. (Med.), Professor, Head of the Department of Phthisiology, Pulmonology, and Infectious Diseases, Omsk State Medical University, Omsk, Russia; amordik@mail.ru, ORCID: https://orcid.org/0000-0001-6196-7256
Natalya V. Bagisheva, Dr. Sci. (Med.), Associate Professor, Professor at the Department of Phthisiology, Pulmonology, and Infectious Diseases, Omsk State Medical University; TB specialist, Omsk Central District Hospital, Omsk, Russia; ppi100@mail.ru, ORCID: https://orcid.org/0000-0003-3668-1023
Yulia V. Arbuzova, Rheumatologist, Head of the Rheumatology Department, Regional Clinical Hospital, Omsk, Russia; elis-panova@yandex.ru
Similar Articles
