2018 Section 5 - Rhinology and Allergic Disorders

RESOLVE 6-month outcomes

Bilateral Polyp Grade vs. Time (days)

0

30

60

90

120

150

180

0.00 0.00

-1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0

*

*

*

* *

*

Change from baseline

*

Treatment

Control

FIGURE 3. Change from baseline in mean bilateral polyp grade during 6 months following sinus implant placement (treatment) or sham procedure (control) showing significant treatment effect at all time points. Means and p values obtained from analysis of covariance with baseline values as covariate and the site and treatment group as fixed effects. * p < 0.05 vs control.

Efficacy endpoints Endoscopic measures

All patients underwent at least 1 prior ESS for medically refractory CRSwNP, and the majority of patients in each group had more than 1 prior ESS (58% treatment, 66% control). All patients were considered to be candidates for revision ESS per study criteria; 87% of them were previ- ously offered revision ESS but 69% declined, 16% were undecided, and only 2% were considering it. The study re- quired bilateral polyposis with a minimum grade 2 on one side. Among 25 patients with grade 1 polyp on one side (8 treatment, 17 control), the majority (68%) reported per- sistent nasal obstruction/congestion symptoms of grade 3 and higher. The study criteria for revision ESS required at least 1 course of oral steroids in the preceding 6 months; 98% of patients received at least 1 course of oral steroids (2 patients refused it because of side effects), 70% received at least 2 courses, and 45% received at least 3 courses of oral steroids since recurrence of symptoms. The study cri- teria for revision ESS also required that patients had been using topical intranasal steroid irrigation or spray daily prior to enrollment. There were 99% of patients who used topical intranasal steroid irrigation or spray daily; 30% for 1 month, 8% for 1 to 6 months, 12% for 6 to 12 months, and 49% for more than 1 year. There were 94% of patients who had sinus infection requiring treatment with antibi- otics within 2 years prior to enrollment; 7% had 1 episode, 15% had 2 episodes, 41% had 3 to 4 episodes, and 31% more than 4 episodes. After the baseline procedure, medication use was tracked and assessed on a standardized case report form. In both groups, patient compliance with Nasonex dosing was 100% at all time points through day 60. At day 90, dosing compliance was 100% in the treatment group and 94% (44/47 patients) in the control group. At 6 months, dos- ing compliance was 94% and 89%, in the treatment and control groups, respectively.

At 6 months, the treatment group experienced a signifi- cantly greater reduction in bilateral polyp grade ( − 0.71 ± 1.53 vs 0.02 ± 1.16; p = 0.018; Fig. 3) and percent eth- moid obstruction on 100-mm VAS ( − 16.5 ± 27.80 vs 4.96 ± 21.96; p < 0.001; Fig. 4) compared to the control group according to clinical investigator judgment. A statis- tically significant difference between groups was observed in both measures through the entire 6-month study pe- riod. A 1-grade reduction in bilateral polyp burden, which has been defined as clinically significant in prior clinical trials, 7 was experienced by 50% of treatment patients com- pared to 28% of controls. A 2-grade reduction was expe- rienced by 27% of the treatment patients compared to 7% of controls. Odds ratios were calculated to assess the asso- ciation between treatment group and changes in bilateral polyp grade. Treated patients were 1.8 and 4.1 times more likely to experience 1-point and 2-point reductions from baseline in bilateral polyp grade, respectively, compared to controls. Endoscopic grading by the independent panel corrob- orated the previously reported findings by the clinical investigators. 15 According to the independent panel, at 3 months the treatment group experienced a significantly greater reduction in percent ethmoid sinus obstruction on 100-mm VAS compared to the control group ( − 17.1 ± 19.4 vs − 5.6 ± 18.3; p = 0.010). The treatment group also experienced a 2-fold reduction in bilateral polyp grade compared to the control group, although this difference did not reach statistical significance ( − 0.76 ± 0.88 vs − 0.38 ± 1.00; p = 0.099). The reduction in bilateral polyp grade reached statistical significance in a subset of patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel − 0.80 ± 0.81

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

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