2018 Section 5 - Rhinology and Allergic Disorders

Forwith et al.

C urrent treatment options for chronic sinusitis patients with recurrence of sinonasal polyps after endoscopic sinus surgery (ESS) are limited to systemic steroids or repeat ESS with polypectomy. 1–5 Although mometasone furoate topical nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the treatment of allergic rhinitis and nasal polyposis, it has not been studied in post-ESS patients with recalcitrant disease. 6,7 Because only about 30% of corticosteroid delivered via intranasal spray is de- posited in the nasal passage, 8 and even less reaches the sinus anatomy, a more effective route of administration is of great clinical interest. Bioabsorbable, mometasone furoate–eluting sinus im- plants have been developed to maintain the results of sinus surgery by preventing inflammation and stenosis of the sinus openings during the postoperative healing pe- riod. The sustained, localized release of corticosteroid ex- pedites the wound healing process and decreases mucosal edema in the perioperative setting. Current FDA-approved steroid-eluting sinus implants significantly reduce the need for post-ESS interventions through localized, controlled de- livery of 370 µ g of mometasone furoate for 1 month. 9–11 In-office placement of this implant has been shown to be feasible, safe, and effective in reducing inflammation and chronic rhinosinusitis (CRS) symptoms. 12 In-office place- ment of another steroid-eluting sinus implant with higher corticosteroid content releasing 1350 µ g over 3 months has been shown to reduce inflammation and reestablish patency of sinuses reobstructed by polyps beyond the perioperative period, 13 without risk of systemic exposure. 14 The safety and efficacy of in-office placement of the implant with 1350 µ g of mometasone furoate have been assessed further in a multicenter, randomized, parallel group, controlled, blinded clinical study. 15 Previously reported 3-month re- sults demonstrated a symptomatic improvement and sta- tistically significant reduction in both the polyp grade and ethmoid sinus obstruction as judged endoscopically by clin- ical investigators. 15 We report herein 3-month endoscopic outcomes by an independent panel of surgeons corroborating previ- ously reported findings by clinical investigators, as well as longer-term endoscopic and patient-reported outcomes at 6 months, to demonstrate sustained therapeutic effect of the steroid-eluting implant for in-office treatment of CRS patients with nasal polyposis (CRSwNP).

FIGURE 1. Steroid-eluting sinus implant with controlled release of 1350 µ g of mometasone furoate over 90 days for in-office treatment of re- current ethmoid sinus obstruction after ESS. ESS = endoscopic sinus surgery. ethmoid sinus cavity and to be self-retaining in the cavity as polypoid tissue recedes. The polymer matrix contains 1350 µ g of mometasone furoate and provides gradual re- lease of the drug over 3 months. The onset of action of the implant is immediate by creating and maintaining an opening in the obstructed middle meatus and ethmoid si- nus. This restores ventilation and drainage, reducing the sensation of nasal blockage and congestion, which is the hallmark symptom of CRSwNP. 3,4 Study design This was a prospective, randomized, controlled, parallel group, blinded clinical trial that enrolled 100 patients at 18 clinical centers across the United States. Patients had confirmed diagnosis of CRS 16 and were candidates for re- vision ESS based upon recurrent symptoms and bilateral polyposis (minimum grade 2 on one side). The participating clinical sites obtained institutional review board approval for the protocol and written informed consent from all pa- tients prior to study entry. The study was registered on ClinicalTrials.gov under identifier NCT01732536. The study patients and procedures have been described. 15 In summary, the study included adult patients (18 years or older) with CRS who were considered candidates for re- vision sinus surgery because of recurrent post-ESS bilat- eral ethmoid sinus obstruction due to polyposis despite repeated aggressive corticosteroid therapy (ongoing topi- cal intranasal steroid irrigation or spray together with re- peated courses of treatment with oral steroids and/or sinus steroid irrigations within 6 months prior to enrollment). Surgical candidacy was determined between clinician and patient based on clinical judgment, patient medical history, symptom burden, disease stage, objective findings using

Patients and methods Implant description

The steroid-eluting sinus implant used in this study was provided by Intersect ENT (Menlo Park, CA) for investiga- tional use. The implant is made of a bioabsorbable polymer and has a self-expanding, non-obstructive design (Fig. 1), which allows it to adjust to fit in a previously-operated eth- moid sinus cavity. The implant has an arched shape, which gives it sufficient radial strength to dilate an obstructed

International Forum of Allergy & Rhinology, Vol. 6, No. 6, June 2016

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