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Review
. 2024 Nov 16:62:101533.
doi: 10.1016/j.nmni.2024.101533. eCollection 2024 Dec.

Risk of tuberculosis disease in patients receiving TNF-α antagonist therapy: A meta-analysis of randomized controlled trials

Fatemeh Khelghati  1 , Mohammad Rahmanian  1 , Elaheh Eghbal  2 , Zahra Sadat Seghatoleslami  3 , Mehdi Goudarzi  1 , Aliasghar Keramatinia  4 , Catherine Wm Ong  5 , Delia Goletti  6 , Lia D'Ambrosio  7 , Rosella Centis  8 , Mohammad Javad Nasiri  1 , Giovanni Battista Migliori  8
Affiliations
Review

Risk of tuberculosis disease in patients receiving TNF-α antagonist therapy: A meta-analysis of randomized controlled trials

Fatemeh Khelghati et al. New Microbes New Infect. .

Abstract

Introduction: Tuberculosis (TB) risk associated with tumor necrosis factor-alpha (TNF-α) antagonist therapy in patients with autoimmune diseases is a significant concern. This study aims to evaluate the risk of TB disease associated with TNF-α antagonist therapy.

Methods: An extensive search of PubMed/MEDLINE, EMBASE, and the Cochrane CENTRAL databases was conducted to identify randomized controlled trials (RCTs) assessing TB disease risk in patients receiving TNF-α antagonist therapy available until November 1, 2024. The pooled statistic used was the weighted odds ratio (OR) and a corresponding 95 % confidence interval (CI). Statistical analysis was performed using Comprehensive Meta-Analysis software, version 3.0 (Biostat Inc., Englewood, NJ, USA).

Results: Fifty-six RCTs, totaling 22,212 adult patients, met the specified eligibility criteria. Pooled analysis revealed an increased risk of TB disease associated with TNF-α antagonist therapy (OR 1.52, 95 % CI 1.03-2.26, p = 0.03). Subgroup analyses indicated a higher risk in patients with rheumatoid arthritis (RA) (OR 2.25, 95 % CI 1.13-4.45, p = 0.02), while no significant associations were found in patients with ankylosing spondylitis (AS) or psoriasis (Ps). Analyses by specific TNF-α antagonist drugs did not yield significant associations with risk of TB disease.

Conclusion: Our study highlights an increased risk of TB disease associated with TNF-α antagonist therapy, particularly in patients with RA. However, the absence of significant associations in AS or Ps patients suggests disease-specific variations in risk of TB disease. Further research is needed to elucidate the long-term safety profile of TNF-α antagonist drugs and their associations with risk of TB disease in different patient populations.

Keywords: Adalimumab; Autoimmune diseases; Certolizumab pegol; Etanercept; Golimumab; Infliximab; Rheumatoid arthritis; TNF-α antagonist therapy; Tuberculosis.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flow chart of study selection for inclusion in the systematic review and meta-analysis.
Fig. 2
Fig. 2
Pooled OR of TB disease risk associated with TNF-α antagonists.
Fig. 3
Fig. 3
Funnel plot of included studies.
See this image and copyright information in PMC

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