2018 Section 5 - Rhinology and Allergic Disorders

Forwith et al.

0

30

60

90

120

150

180

5

0

-5

-10

-15

*

-20

*

*

*

-25

Change from baseline on 100mm VAS

*

*

*

-30

-35

Treatment

Control

FIGURE 4. Change from baseline in ethmoid sinus obstruction evaluated using 100-mm visual analogue scale (VAS) during 6 months following sinus implant placement (treatment) or sham procedure (control) showing significant treatment effect at all time points. Means and p value obtained from analysis of covariance with baseline values as covariate and the site and treatment group as fixed effects. * p < 0.05 vs control.

[n = 40] vs control − 0.38 ± 1.05 [n = 27]; p = 0.049). In this subset, the change from baseline in percent ethmoid sinus obstruction experienced by the treatment group was also statistically significantly greater than the control group ( − 19.9 ± 19.3 vs − 8.6 ± 20.3; p = 0.011). Patient-reported outcomes The treatment group improved symptomatically over 6 months. The change from baseline to 6 months in the mean NOSE score was − 25.6 ± 28.2 in the treatment group compared to − 12.2 ± 23.9 in the control ( p = 0.021, Fig. 5). At 6 months, the treatment group experienced greater than 2-fold reduction in nasal obstruction and con- gestion score compared to the control group ( − 1.06 ± 1.4 vs − 0.44 ± 1.4; p = 0.124; Fig. 6). Although this 2-fold reduction in nasal obstruction and congestion score was ob- served consistently from month 1 to 6, the differences did not achieve statistical significance because of higher than expected variability in this measure (SD ranged from 1.2 to 1.6). Medical and surgical interventions At 6 months, 31% (16/52) of treatment patients were no longer indicated for repeat ESS, compared to 11% (5/46) of controls. An odds ratio was calculated to assess the as- sociation between treatment group and indication for re- peat ESS. Control patients were at 3.6 times higher risk of remaining indicated for ESS at 6 months compared to

treatment patients. Between month 3 and 6, one control patient elected to undergo revision surgery.

Safety assessments There was 1 serious adverse event reported in the control group. A patient was hospitalized for depression and suici- dal ideation between month 3 and 6. The overall incidence of adverse events through 6 months was similar between the treatment and control group (72% vs 77%), with sinusitis (MedDRA System Organ Class: infections and infestations) being most common (36% vs 55%). Other adverse events were infrequent and balanced between the groups (in order of decreasing frequency: upper respiratory tract infection, epistaxis, nasopharyngitis, asthma, headache, and presyn- cope.) Discussion This study was the first multicenter, randomized, con- trolled, blinded clinical trial to assess the safety and efficacy of office-based insertion of a steroid-eluting sinus implant in CRSwNP patients. The 3-month results reported previ- ously by Han et al. 15 were shown to be sustained longer term through 6 months. The localized, controlled delivery of 1350 µ g of mometasone furoate from the implant was shown to be effective in reducing polyposis and its associ- ated hallmark symptomatology over a 6-month timeframe. With only 2 mild implant-related adverse events (nasal dis- comfort and nasal odor) and absence of ocular changes during the initial 3-month follow-up timeframe, 15 and no

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

228