In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis

Abstract

Background A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients. Methods Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90. Results At day 90, patients receiving implants and MF nasal spray (MFNS) experienced significant improvements in nasal obstruction/congestion (NO/C) score ( P = .0095), bilateral polyp grade (BPG, P = .0008), and ethmoid sinus obstruction ( P < .0001) compared to control using MFNS alone. Fewer treatment than control patients remained candidates for RESS (41.0% vs 69.3%, P < .0001). All subgroups experienced significant treatment effects, except NO/C in smokers ( P = .0509) and patients without altered smell ( P = .1873). Subgroups without asthma and with only 1 prior ESS experienced largest treatment effect on NO/C, and those with recent surgery <24 months and BPG >5 showed largest effect on endoscopic end points and RESS. Control patients with ESS <24 months were at 7 times highest risk for RESS ( P < .0001). One (0.4%) patient experienced implant-related serious adverse event (epistaxis). Conclusion On pooled analysis, MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS < 24 months.

International consensus statement on allergy and rhinology: rhinosinusitis 2021

“…The RCTs utilized bilateral sham procedures as interpatient controls, with both implant and control groups receiving intranasal steroid sprays. At 90 days, 59% of treated patients vs 31% of controls were no longer indicated for revision ESS, although this decreased to 31% of treated patients and 11% of controls at 6 months 1608,1612 . In terms of adverse events, there was no significant increase in intra ocular pressure or cataracts but 1 episode of epistaxis was reported in the larger Phase 3 trial 1606,1607 …”

“…Biodegradeable corticosteroid eluting‐implants provide targeted sustained release of medication into the sinus cavity to reduce nasal polyposis (NP) and obstruction 1605–1608 . Currently, the only steroid‐eluting implant approved by the US FDA to treat adult patients with NP is the Sinuva implant (Intersect ENT, Palo Alto, CA).…”

“…The Sinuva implant has been investigated in 2 RCTs and a pooled analysis (n = 375), which showed significant improvement in endoscopic polyp grade, ethmoid sinus obstruction, and patient‐reported symptoms relative to controls at 90 days 1607,1608,1611 . The RCTs utilized bilateral sham procedures as interpatient controls, with both implant and control groups receiving intranasal steroid sprays.…”

“…For CRSwNP, microdebrider‐assisted polypectomy can be utilized in patients with recurrent polyposis after ESS 1804,1805 . Steroid‐eluting stent placement in the ethmoid cavity is another effective in‐office treatment option for recurrent polyposis after ESS 1606,1608,1806 . In‐office primary ESS and BCD have not been validated in patients with CRSwNP.…”

Update in Rhinology and Allergy

“…Another form of topical steroids, mometasone furoate sinus implants, provided significant improvements in outcomes including nasal obstruction/ congestion score, bilateral polyp grade, and ethmoid sinus obstruction and potentially less need for surgical revision compared to mometasone furoate nasal spray in patients with CRS with nasal polyps. 8 In a systematic review and meta-analysis from Seresirikachorn et al, the combination of leukotriene receptor antagonist plus antihistamine compared to antihistamine alone was more effective in improving nasal symptom score, rhinorrhea, and sneezing in patients with perennial AR. 9 In addition, the authors in this issue of AJRA continue to expand our knowledge in terms of surgical techniques and improving outcomes after surgical intervention.…”