Research AppraisalSystematic Review

Impact of IL-4/IL-13 Blockade with Dupilumab on the Microbiome in Type 2 Inflammatory Diseases: A Systematic Review

Current allergy and asthma reportsMari, Pier-Valerio, Carriera, Lorenzo, Saviano, Angela et al.16 May 2026DOI

Clinical Snapshot

65CEBM
Evidence: ModerateSystematic Review

PICO Framework

P — PopulationPatients with type 2 inflammatory diseases (primarily atopic dermatitis, chronic rhinosinusitis with nasal polyps, NSAID-exacerbated respiratory disease)
I — InterventionDupilumab (IL-4/IL-13 blockade)
C — ComparatorPre-treatment baseline or control groups
O — OutcomesMicrobiome changes across anatomical sites (skin, sinonasal tract, gut) including microbial diversity, specific taxa abundance, and metabolic pathways

Bottom Line

This systematic review of 15 studies demonstrates that dupilumab produces compartment-specific microbiome changes in type 2 inflammatory diseases. The strongest evidence comes from skin studies showing consistent reductions in pathogenic Staphylococcus aureus and increased microbial diversity in atopic dermatitis patients. Sinonasal studies suggest beneficial shifts toward healthier microbial communities, while gut microbiome evidence remains limited. These findings support dupilumab's therapeutic mechanism through IL-4/IL-13 blockade and restoration of microbial homeostasis. However, the evidence is primarily observational and lacks quantitative synthesis. While promising for understanding drug mechanisms, microbiome changes are not yet ready for clinical biomarker use. Australian clinicians can be reassured that dupilumab's benefits extend beyond symptom control to include restoration of healthy microbial communities, particularly in skin and sinonasal sites.

Evidence: Moderate

Key Findings

  • P Value: Not reported in abstract

  • Effect Size: Consistent reduction in Staphylococcus aureus and increased microbial diversity in skin studies

  • Primary Outcome: Compartment-specific microbiome changes with dupilumab treatment

  • Nnt Or Sensitivity: Microbiome signatures as potential biomarkers require further validation

  • Confidence Interval: Not reported in abstract

Clinical Application

Microbiome monitoring not routinely available in clinical practice; research findings support dupilumab's mechanism of action Dupilumab PBS-listed for severe atopic dermatitis and asthma; findings support therapeutic rationale and may inform future biomarker development Australian patients with atopic dermatitis, chronic rhinosinusitis with nasal polyps, and NSAID-exacerbated respiratory disease receiving dupilumab

Abstract

PURPOSE OF REVIEW: To systematically review current evidence on microbiota changes associated with dupilumab treatment across different anatomical sites in type 2 inflammatory diseases. RECENT FINDINGS: Fifteen studies were included, comprising two randomized trials and thirteen observational studies, mostly in atopic dermatitis, with fewer data in chronic rhinosinusitis with nasal polyps and NSAID-exacerbated respiratory disease. The skin was the most frequently investigated site, followed by the sinonasal tract and gut. Across skin studies, dupilumab was consistently associated with reduced Staphylococcus aureus, increased microbial diversity, and enrichment of commensal taxa. Sinonasal studies suggested shifts toward more eubiotic microbial communities. Gut evidence was limited, although one study suggested modulation of tryptophan metabolism-related pathways.  Dupilumab appears to exert compartment-specific and disease-dependent effects on the microbiome. The strongest evidence concerns the skin and sinonasal compartments, whereas gut microbiota changes remain poorly defined. Further prospective studies are needed to assess microbiota signatures as potential biomarkers of response.

References

  1. 1.Mari, P. V., Carriera, L., Saviano, A., Ricci, A., Coppola, A., Ielo, S., Lipsi, R., Dodaj, M., Gennari, F., Gullà, M., Stivalini, D., Pellegrino, M. G., Migneco, A., De Corso, E., & Ojetti, V. (2026). Impact of IL-4/IL-13 blockade with dupilumab on the microbiome in type 2 inflammatory diseases: A systematic review. Current Allergy and Asthma Reports. https://doi.org/10.2147/CCID.S393406
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