Dupilumab Does Not Cause Osteomyelitis
Based on comprehensive safety data from clinical trials and real-world evidence, dupilumab (Dupixent) is not associated with an increased risk of osteomyelitis and actually demonstrates a significantly reduced risk of serious infections, including bone infections, compared to other systemic immunosuppressants.
Evidence Against Osteomyelitis Risk
Clinical Trial Safety Data
Pooled analysis of seven randomized controlled trials (2,932 patients with moderate-to-severe atopic dermatitis) showed dupilumab significantly reduced serious/severe infections by 57% compared to placebo (risk ratio 0.43; p < 0.05). 1
Long-term safety data from up to 4 years of continuous dupilumab treatment demonstrated consistently low rates of serious and/or severe infections (1.39 events per 100 patient-years), with the cumulative number of patients experiencing serious infections actually decreasing year-over-year. 2
Real-World Comparative Safety
A large global cohort study (n=10,913 dupilumab users) found dupilumab was associated with a significantly decreased risk of osteomyelitis compared to methotrexate (HR not specified but statistically significant reduction noted). 3
This same study demonstrated dupilumab reduced the risk of systemic infections by 61% compared to methotrexate (HR 0.39; 95% CI 0.34-0.44) and by 53% compared to cyclosporine (HR 0.47; 95% CI 0.40-0.56) during the first year of treatment. 3
Mechanism of Reduced Infection Risk
Dupilumab selectively blocks IL-4 and IL-13 signaling (type 2 inflammation) without broadly suppressing the immune system, unlike traditional immunosuppressants such as cyclosporine, methotrexate, or TNF-alpha inhibitors. 4
Post-hoc analysis of respiratory studies showed dupilumab reduced investigator-reported respiratory infections by 22-38% compared to placebo, suggesting the drug may actually improve host defense against certain infections. 5
Contrast with Other Biologics
Osteomyelitis has been documented with TNF-alpha inhibitors (such as infliximab) used for psoriasis and other inflammatory conditions, but this adverse effect profile does not extend to dupilumab. 6
The mechanism differs fundamentally: TNF-alpha inhibitors broadly decrease inflammatory responses to infection, while dupilumab's selective IL-4/IL-13 blockade preserves critical antimicrobial immune pathways. 6
Clinical Implications
Dupilumab can be safely used in patients with atopic dermatitis without specific concern for osteomyelitis risk. 2, 1, 3
In patients with susceptibility to infections or history of serious infections, dupilumab may actually be preferred over traditional systemic immunosuppressants like cyclosporine or methotrexate due to its superior infection safety profile. 3
The reduced risk of skin infections (bacterial and non-herpetic) with dupilumab (risk ratio 0.44; p < 0.001) may be particularly relevant for patients with atopic dermatitis who have compromised skin barrier function. 1
Important Caveats
While dupilumab does not cause osteomyelitis, patients with atopic dermatitis may develop osteomyelitis from other causes (trauma, hematogenous spread, contiguous infection). 4
If osteomyelitis is suspected in a patient on dupilumab, standard diagnostic workup should proceed: plain radiographs initially, followed by MRI if clinical suspicion persists (MRI is the most accurate imaging modality for defining bone infection). 4
The diagnosis of osteomyelitis requires isolation of bacteria from bone specimens with histological evidence of inflammatory cells and osteonecrosis, regardless of what medications the patient is taking. 4