Dupilumab (Dupixent) was approved by the US Food and Drug Administration for adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis who have undergone sinonasal surgery or for whom surgery is not advisable. This represents the first US Food and Drug Administration-approved therapy specifically indicated for allergic fungal rhinosinusitis.

Allergic fungal rhinosinusitis (AFRS) is an uncommon subtype of chronic rhinosinusitis driven by an allergic response to fungal organisms colonizing the sinuses. The condition is characterized by the accumulation of thick, tenacious mucus and occurs in up to 8% of patients with chronic sinus inflammation and nasal polyps. It is more prevalent in warm, humid climates and typically presents in adolescent and young adult patients. Disease progression may result in sinus expansion and erosion of adjacent bone, reported in up to 90% of patients, with possible extension into the orbital cavity or intracranial space. These complications may lead to facial deformity, visual impairment, and neurologic sequelae.

The approval was supported by a 52-week clinical study evaluating dupilumab in adult and pediatric patients aged 6 years and older with AFRS. Treatment with dupilumab improved sinus opacification compared with placebo, as assessed by computed tomography using the Lund-Mackay score. Improvements were also observed in nasal polyp size, nasal congestion, and olfactory function. Dupilumab reduced the need for systemic corticosteroids and sinus surgery over 52 weeks compared with placebo. In addition, treatment reduced sinus bone erosion, a complication that distinguishes AFRS from other forms of chronic rhinosinusitis.

The safety profile of dupilumab in this population was consistent with findings from clinical trials and postmarketing experience in patients with chronic rhinosinusitis with nasal polyps. No new safety signals were identified. In pediatric patients aged 6 years to younger than 18 years, efficacy was extrapolated from adult data, supported by similar disease pathophysiology and comparable drug exposure with weight-based dosing. Pediatric safety data were derived from studies in other approved indications.

Dupilumab received priority review designation for this indication. The most common adverse reactions include injection-site reactions, eosinophilia, insomnia, toothache, gastritis, and arthralgia.

Source: US Food and Drug Administration