Surgery Subgroup: SNOT-22

February 10, 2023

By Fingerpaint Devs

Post hoc subgroup analysis

Improvement in SNOT-22 in patients with or without prior sinus surgery

Reduction in SNOT-22 score at Week 16 in the subgroups of patients with or without prior sinus surgery¹

A post hoc analysis of a pooled population from NAVIGATE I and NAVIGATE II analyzed improvement in SNOT-22 score in the subgroup of patients who had sinus surgery and those without sinus surgery prior to study entry¹
Patients were excluded from the studies if they had a history of sinus or nasal surgery within 6 months before screening^2,3

The following results are descriptive and should be interpreted with caution.

Post hoc analysis of NAVIGATE I and II
Pooled subgroup data (n=481)

with prior sinus surgery

without prior sinus surgery

with and without prior sinus surgery

Baseline grade: EDS-placebo, 3.7; XHANCE 186 mcg BID, 3.8; XHANCE 372 mcg BID, 3.7.^1-3

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.

Please see additional Important Safety Information and full Prescribing Information, including Instructions for Use.

References:

Data on file. OptiNose US, Inc.
Leopold DA, Elkayam D, Messina JC, et al. NAVIGATE II: randomized double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol. 2019;143(1):126-134.
Sindwani R, Han JK, Soteres DF, et al. NAVIGATE I: randomized, placebo-controlled, double-blind trial of the Exhalation Delivery System with fluticasone for chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2019;33(1):69-82.

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INDICATIONS

XHANCE is a corticosteroid indicated for the treatment of chronic rhinosinusitis with or without nasal polyps in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:
Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.
Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
Assess for decrease in bone mineral density initially and periodically thereafter.

ADVERSE REACTIONS:

Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥ 3%) are epistaxis, headache, and nasopharyngitis.
Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

DRUG INTERACTIONS:
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS:
Hepatic impairment. Monitor patients for signs of increased drug exposure.

Please see Full Prescribing Information pdf opensfull Prescribing Information, including Instructions for Use.