Arthritis-Related Adverse Reactions of Dupilumab in Treatment of Chronic Rhinosinusitis.

OBJECTIVE

To investigate the incidence and risk factors for dupilumab-associated-arthritis (DAA) in chronic rhinosinusitis with nasal polyps (CRSwNP) and compare DAA prevalence across asthma and atopic dermatitis (AD) using the FDA Adverse Event Reporting System (FAERS).

METHODS

We queried FAERS from January 2020 to June 2024. Reports were stratified by treatment indication (CRSwNP, asthma, AD). DAA events included arthralgia, arthritis, tenosynovitis, and related musculoskeletal conditions. Multivariable logistic regression assessed associations between DAA and sex, age, and indication. Disproportionality analysis (DPA) via OpenVigil-FDA evaluated whether DAA was more frequently reported compared with other drugs.

RESULTS

Among 207,370 dupilumab-associated reports, 5055 (2.4%) were DAA-related. Prevalence was highest in CRSwNP (11.2%), followed by asthma (8.7%) and AD (4.7%). Logistic regression revealed increased DAA odds in CRSwNP (OR 1.81, p < 0.001) and asthma (OR 1.27, p < 0.001), and decreased odds in AD (OR 0.87, p = 0.01). Adults ≥ 50 exhibited elevated risk across all groups. DPA demonstrated DAA was more commonly reported in CRSwNP (ROR 1.92) and asthma (ROR 1.49) compared to all other drugs. AD and CRSwNP patients exhibited elevated risk (OR 3.21, p < 0.001).

CONCLUSION

DAA is more frequent in patients treated for CRSwNP and asthma compared to AD. Older age and coexisting type-2 inflammatory conditions are associated with increased risk. Clinicians should counsel patients regarding musculoskeletal symptoms and monitor for joint-related AEs during dupilumab therapy, particularly in CRSwNP treatment. Limitations of FAERS include the presence of reporting bias causing the potential for DAA to be underreported, as well as the inability to calculate its incidence.