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Infectious Risks Associated with Biologic Therapies in Autoimmune, Rheumatologic and Dermatologic Diseases: A
Stefania Capuccio1,2, Francesco Romano3, Joan R Rello4
1Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy.
Microorganisms
|June 26, 2026
Summary
Biologic and targeted synthetic DMARDs control autoimmune diseases but increase infection risks. Proactive screening, vaccination, and prophylaxis are crucial for managing these infectious complications.
Area of Science:
- Immunology
- Rheumatology
- Infectious Diseases
Background:
- Biologic and targeted synthetic DMARDs offer significant advancements in managing autoimmune diseases (ADs).
- These immunomodulatory therapies, however, elevate the risk of various infections.
- Understanding and mitigating these infection risks is critical for patient safety.
Purpose of the Study:
- To review infectious risks associated with biologic DMARDs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) in AD patients.
- To characterize infection profiles by drug class and identify risk factors.
- To provide evidence-based recommendations for infection screening, prevention, and management.
Main Methods:
- A narrative review synthesizing evidence from literature searches (PubMed, Embase, Cochrane Library) up to March 2026.
- Prioritization of data from major international registries (BSRBR-RA, DANBIO, RABBIT) and guidelines (ACR, EULAR, IDSA).
- Analysis focused on infection-related outcomes linked to bDMARDs and tsDMARDs.
Main Results:
- TNF-α inhibitors and rituximab showed higher serious infection rates; IL-17 and IL-23 inhibitors had lower profiles.
- Patient-related risk factors included steroid use, older age, and prior serious infections.
- An integrated framework for risk stratification across different drug classes and ADs was developed.
Conclusions:
- bDMARDs and tsDMARDs are innovative, effective AD treatments with favorable benefit-risk ratios when combined with prevention strategies.
- Systematic prevention, including universal screening for tuberculosis and viral hepatitis, parasitic screening, vaccination, and prophylaxis, can mitigate infectious complications.
- Integrated risk stratification and proactive management are key to safe and effective use of these therapies.
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