Biologics and TB: Are You at Risk?
"A new study reveals the tuberculosis risks associated with biologic therapies for immune-mediated diseases, particularly in TB-endemic regions. Find out if you're at risk and what precautions to take."
Biologic therapies have transformed the treatment of immune-mediated diseases like rheumatoid arthritis, IBD, and psoriasis, offering targeted relief where traditional medications fall short. However, these powerful drugs, which suppress parts of the immune system, come with their own set of risks.
One significant concern is the heightened susceptibility to infections, including tuberculosis (TB). While this risk is known, a new study sheds light on the specific extent of this risk in TB-endemic regions like Hong Kong, offering valuable insights for patients and healthcare providers.
This article unpacks the findings of this population-based study, explaining the increased TB risk associated with biologic therapies, particularly infliximab, and providing a clear understanding of what these findings mean for individuals with immune-mediated diseases.
TB Diagnostic Methods and Gaps
Laboratory methods have played a significant role in TB diagnosis, but reported limitations include sensitivity and specificity, prolonged turnaround times, and deficiencies in diagnosing latent TB, TB complicated by other diseases, and drug-resistant TB. A 2026 review also identifies gaps in predicting progression from Mycobacterium tuberculosis infection to TB disease, reliance on sputum, and the lack of universally accessible point-of-care tests. The ECDC handbook’s first version was published in 2011 and was later revised and renamed in 2016, with a subsequent version in 2018.
Understanding the TB Risk with Biologics
The study, conducted in Hong Kong, analyzed data from 2,485 patients with immune-mediated diseases receiving biologic therapies. The results revealed a stark reality: patients on biologics had a more than 10-fold increased risk of developing active TB compared to the general population.
- Overall Increased Risk: Patients on biologics face a significantly higher risk of TB.
- Infliximab Alert: Infliximab carries the highest TB risk among the biologics studied.
- TNF Inhibitors: TNF inhibitors, in general, elevate TB risk compared to non-TNF biologics.
Risk Findings and Study Limitations
One cited report says infliximab has been reported to carry a higher TB reactivation risk than etanercept, which appears to confer relatively lower risk in clinical studies. However, a U.S. analysis of TB cases from 2010–2017 lacked a denominator for all TNF-α inhibitor users and did not include the type of inhibitor or concurrent prednisone use, limiting comparisons of risk between specific therapies. In a pediatric biologic-therapy study, 55.4% of serious infections occurred during the first six months of each treatment period; the snippet notes other cohorts found mean times to first infection of 3–8 months.
Persistent Vaccine and Treatment Challenges
BCG remains the sole WHO-approved TB vaccine despite its limitations, and efforts are underway to improve its effectiveness and develop other candidates. A 2025 review describes drug-resistant Mycobacterium tuberculosis strains as an escalating challenge despite the availability of BCG and therapeutic agents, underscoring the need for more effective vaccines and treatments. Another review describes TB as a continuing global health problem despite widespread BCG use, worsened by HIV co-infection and multidrug-resistant strains.
Biologics and TB Vigilance
Biologics are drugs produced through biological processes rather than chemical synthesis; the listed examples include recombinant proteins, antibodies, peptides, antisense oligonucleotides, therapeutic genes, and recombinant and DNA vaccines. Biologic drugs have transformed treatment for some hematologic, autoimmune, and malignant diseases, but may place patients at risk of TB reactivation or acquisition. The risk is described as highest with TNF-α inhibitors, and the source identifies infliximab, adalimumab, and golimumab among the monoclonal antibodies in that class. A related review advises vigilance for TB because many biologics affect T cells or other cytokines involved in the immune response to TB.
What This Means For You
If you are currently taking or are considering starting biologic therapy for an immune-mediated disease, these findings underscore the importance of discussing TB risk with your doctor. Screening for latent TB infection is crucial before starting a biologic, and ongoing monitoring is also recommended.
Expert Perspectives on Screening
An online questionnaire sought expert insights into screening for and treatment of TB infection in patients treated with biologics. A total of 163 respondents across 27 countries answered at least one question. Separately, a 2024 letter describes baseline and annual latent TB screening as the standard of care for patients using biologics, while noting that annual screening is controversial; its retrospective claims analysis set out to examine screening trends and test positivity rates.
Global Burden and System-Level Needs
A 2026 report estimates that 10.7 million people developed TB in 2024, including approximately 620,000 people living with HIV; it describes Mycobacterium tuberculosis as the leading cause of death from a single infectious pathogen globally. Another source reports that WHO documents over 1 million annual TB fatalities and points to drug-resistant strains as a reason for the need for more effective vaccines and treatments. A 2026 commentary argues that integrating TB control with broader development, health-system strengthening, and social-protection frameworks is essential to reduce inequities, interrupt transmission, and support long-term elimination goals.
While the increased risk is concerning, it's important to remember that biologics can significantly improve the quality of life for many individuals with chronic conditions. Understanding the risk allows for informed decision-making and proactive management.
Ultimately, the goal is to strike a balance between the benefits of biologic therapy and the potential risks, ensuring the best possible outcome for each patient. Staying informed, maintaining open communication with your healthcare provider, and adhering to screening and monitoring guidelines are key steps in this process.