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Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a type 2 inflammatory disease of nasal and paranasal sinuses often associated with other atopic/allergic diseases and a negative impact on health-related quality of life. To better understand the prevalence and association of atopic comorbidities and biomarkers of inflammation in a population with more severe CRSwNP, we conducted a post hoc analysis of baseline data acquired in a phase 2a study of dupilumab (NCT01920893). Dupilumab is approved by the US FDA for treatment of adults with moderate-to-severe atopic dermatitis.
METHODS:
60 adult CRSwNP patients refractory to intranasal corticosteroids were randomized (1:1) to 16 weeks of weekly subcutaneous 300 mg dupilumab or placebo, with daily mometasone furoate nasal spray. Comorbidities were evaluated by reviewing patient-reported medical histories at the screening visit along with baseline levels of inflammation biomarkers in the blood.
RESULTS:
Most frequent comorbidities (>10%) were history of asthma (58.3%), allergic rhinitis (56.7%), aspirin and/or nonsteroidal anti-inflammatory drug hypersensitivity (31.7%), allergic conjunctivitis (28.3%), food allergy and/or intolerance (16.7%), hives (13.3%), and atopic dermatitis (11.7%). In patients with history of atopic disease (n=43/60), baseline type 2 biomarkers were numerically higher vs patients without (n=17/60) (mean blood eosinophils, 0.47 vs 0.31 Giga/L; thymus and activation-regulated chemokine, 483.20 vs 396.07 pg/mL; plasma eotaxin-3, 65.54 vs 55.39 pg/mL; serum total IgE, 183.00 vs 125.36 IU/mL).
CONCLUSIONS:
Type 2-mediated atopic diseases are frequent comorbidities in patients with CRSwNP refractory to intranasal corticosteroids, and patients with these comorbidities experience numerically higher baseline levels of type 2 biomarkers.