2018 Section 5 - Rhinology and Allergic Disorders

Forwith et al.

with improvements in patient-reported outcomes. The dif- ferences between groups in the change from baseline in NOSE score reached statistical significance at 6 months, and a 2-fold improvement for treatment patients com- pared to controls in nasal obstruction/congestion score was observed from month 1 to 6. We observed higher than expected variability in this latter measure, which explains why these differences did not achieve statistical significance. The improvements observed in our study are compelling, especially considering that both groups received mometa- sone furoate nasal spray (Nasonex) once daily throughout the study follow-up period. In 2 randomized placebo- controlled studies evaluating the use of Nasonex for nasal polyps, change from baseline in bilateral polyp grade through 4 months was − 0.78 and − 1.15, respectively, with once-daily dosing, and change from baseline in nasal con- gestion/obstruction through day 30 was − 0.42 and − 0.47, respectively. 6,7 However, it is important to note that intranasal sprays predominantly target the nasal cavity, rather than the sinuses, and these studies did not include post-ESS revision candidates with recalcitrant polyposis, whereas our study did. This may explain why our control group did not improve by objective endoscopic exami- nation. Bilateral polyp grade, as judged by investigators, was essentially unchanged in the control group over the 6-month follow-up period, whereas the treatment group ex- perienced significant reduction ranging from 0.71 to 1.43. Given that all patients enrolled in the study were con- sidered to be candidates for revision surgery, the study re- sults are quite promising. Nearly 31% of patients in the treatment group were no longer considered to be surgical candidates by the end of the study compared to 11% in the active control group, meaning control patients were at 3.6 times higher risk of still requiring surgery compared to treated patients. The observed level of improvement among some of the control patients was not surprising given that they were maintained on mometasone furoate nasal spray at daily dose of 200 µ g, which has been shown to be ef- fective for treating allergic rhinitis and in reducing nasal polyposis. 6,7,19 Further, patient noncompliance with top- ical steroid use is well known, and so it is likely that the symptomatic improvements observed in the control group were due to better dosing compliance while on the study protocol. A study limitation described previously by Han et al. 15 was that the clinical investigators performing endoscopic grading were not blinded to the treatment assignment. This limitation was mitigated in 2 ways. First, we attempted to minimize the potential for bias in these assessments by requiring instantaneous grading at each study visit, where investigators referred to the standardized grading scales and were not permitted to review their grading from prior vis- its. Second, video-endoscopies from baseline and 3 months were provided to an independent panel of 3 sinus surgeons who were not aware of treatment assignments. The results of the grading by the independent panel corroborated the

endoscopic improvements reported by clinical investiga- tors, providing additional confidence in the robustness of the study conclusions. Finally, the study entry criteria required patients to be surgical revision candidates while concurrently allowing for 1 sinus side to have only grade 1 polyposis. This may have resulted in enrollment of some patients with less opportu- nity for improvement from baseline. The subset analysis in patients with at least a grade 2 polyposis in each nasal cavity suggests that the implant treatment effect may be greater in more diseased CRSwNP patients, and whose revision candidacy may be less debatable. Conclusion The observed symptomatic and endoscopic improvements support the efficacy of the steroid-eluting implant for in- office treatment of CRSwNP after ESS. These longer-term 6-month results demonstrate that the steroid-eluting im- plant represents a durable, safe, and effective treatment strategy for this patient population. Acknowledgement The sponsor (Intersect ENT) provided funding for the in- vestigation as well as administrative and logistical support in coordinating the study across the study sites. We thank the research staff at the study clinical sites for their time, effort and contribution to the RESOLVE Study: William Brown, MD (Primary Investigator), Stephanie Ramos, and Christina Capetillo of South Florida ENT Associates, Miami, FL; Randall Ow, MD (Primary Investigator) and Bryan K. Hughes, CCRC, CRCP, of Sacramento ENT, CA; Steven Miller, MD (Primary Investigator) and Holly Featherstone, CCRP, of Intermountain ENT Specialists, Salt Lake City, UT; Nithin Adappa, MD (Primary In- vestigator) and Laurel Doghramji, RN, of University of Pennsylvania, Philadelphia, PA; Anisa Daftari, PA-C, MPH, of ENT of Georgia, Atlanta, GA; Kathleen Sheeley, RRT, CCRC, of Advanced ENT and Allergy, Louisville, KY; Laura Stone, RN, BSN, CCRC, of Eastern Virginia Medical School, Norfolk, VA; Lisa M. Yen, RN, MSN, CRNP, of Bethlehem ENT Associates, PA; David Poetker, MD (Primary Investigator) and Christy Erbe of Medical College of Wisconsin, Milwaukee, WI; Donna Harakal, RN, CCRC, and Sherrie Wolfe, RN, CCRC, of Northwest- ern University, Chicago, IL; Lewis Romett, MD (Primary Investigator) and Deborah A. Bothwell, CCRC, of Col- orado ENT and Allergy, Colorado Springs, CO; Nathan Sautter, MD (Primary Investigator) and Jess C. Mace, MPH, CCRP, of Oregon Health and Science University, Portland, OR; Rodney Schlosser, MD (Primary Investi- gator), Matthew Newsome, and Tina Storck of Medical University of South Carolina, Charleston, SC; Winton Vaughan, MD (Primary Investigator) and Sharareh (Sherry) Derakhshandeh, PA-C, of CA Sinus Center, Atherton, CA; Todd Schaeffer, MD (Primary Investigator) and

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