Table 3.
Efficacy Outcomes.
| Outcome |
RESOLVE14,15,a |
RESOLVE II 16 |
Pooled Analysis b |
|||
|---|---|---|---|---|---|---|
| Treatment (n = 53) | Control (n = 47) | Treatment (n = 201) | Control (n = 99) | Treatment (n = 246) | Control (n = 129) | |
| NO/C | ||||||
| Baseline | ||||||
| Mean ± SD | 3.63 ± 1.176 | 3.48 ± 1.092 | 2.36 ± 0.488 | 2.35 ± 0.479 | 2.39 ± 0.580 | 2.35 ± 0.645 |
| Change from baseline to day 90 | ||||||
| n (%) | 43 (81.1) | 31 (66.0) | 177 (88.1) | 89 (89.9) | 244 (99.2) | 126 (97.7) |
| Mean ± SD | −1.40 ± 1.380 | −0.52 ± 1.379 | −0.93 ± 0.798 | −0.69 ± 0.791 | −0.98 ± 0.856 | −0.69 ± 0.942 |
| Treatment effect estimate (95% CI) c | −0.88 (−1.26 to −0.09) | −0.27 (−0.48 to −0.07) | −0.24 (−0.42 to −0.06) | |||
| P c | .0254 | .0248 d | .0095 | |||
| BPG | ||||||
| Baseline | ||||||
| Mean ± SD | 5.24 ± 0.649 | 5.42 ± 0.825 | 5.48 ± 1.132 | 5.43 ± 1.009 | 5.40 ± 1.107 | 5.34 ± 1.076 |
| Change from baseline to day 90 | ||||||
| n (%) | 40 (75.5) | 27 (57.4) | 195 (97.0) | 97 (98.0) | 238 (96.7) | 127 (98.4) |
| Mean ± SD | −0.80 ± 0.812 | −0.38 ± 1.049 | −0.56 ± 1.059 | −0.15 ± 0.907 | −0.60 ± 1.021 | −0.19 ± 0.950 |
| Treatment effect estimate (95% CI) c | −0.42 (−0.87 to −0.00) | −0.35 (−0.60 to −0.09) | −0.37 (−0.59 to −0.16) | |||
| P c | .0490 | .0073 | .0008 | |||
| ESO | ||||||
| Baseline | ||||||
| Mean ± SD | 70.59 ± 18.20 | 62.74 ± 25.673 | 69.16 ± 19.869 | 67.03 ± 18.552 | 69.94 ± 19.415 | 68.91 ± 19.097 |
| Change from baseline to day 90 | ||||||
| n (%) | 52 (98.1) | 47 (100) | 195 (97.0) | 97 (98.0) | 239 (97.2) | 127 (98.4) |
| Mean ± SD | −17.05 ± 19.361 | −5.57 ± 18.279 | −11.28 ± 18.108 | −1.87 ± 14.364 | −12.71 ± 18.619 | −2.96 ± 16.208 |
| Treatment effect estimate (95% CI) c | −9.83 (−17.2 to −2.43) | −7.96 (−12.1 to −3.83) | −8.97 (−12.7 to −5.22) | |||
| P c | .0099 | .0007 d | <.0001 | |||
| Proportion of patients indicated for RESS | ||||||
| Baseline n (%) | 53 (100.0) | 47 (100.0) | 201 (100) | 99 (100) | 246 (100.0) | 129 (100.0) |
| Day 90 n (%) | 25 (48.1) | 36 (78.3) | 78 (39.0) | 62 (63.3) | 100 (41.0) | 88 (69.3) |
| P e | .0022 | .0004 d | <.0001 | |||
| Odds ratio (95% CI) | 3.9 (1.6–9.4) | 2.7 (1.6–4.4) | 3.2 (2.1–5.1) | |||
Abbreviations: ANCOVA, analysis of covariance; BPG, bilateral polyp grade; CI, confidence interval; ESO, ethmoid sinus obstruction; ESS, endoscopic sinus surgery; MF, mometasone furoate; NO/C, nasal obstruction/congestion; NP, nasal polyps; RESS, revision ESS; SD, standard deviation; VAS, visual analog scale.
To allow comparison across the studies and with the pooled analysis results, the RESOLVE results for NO/C score (scale 0–5) and BPG by panel (scale 0–8) are presented for the subset of patients with NP grade ≥ 2 on each side, as reported by Han et al. 15 and Forwith et al. 14
Analysis of the pooled data from RESOLVE and RESOLVE II for patients with NP grade ≥ 2 on each side and confirmed candidacy for RESS at screening and 4 prespecified end points: NO/C score (scale 0–3) by patients using a reflective questionnaire, BPG (scale 0–8) based on a centralized, blinded video-endoscopy review by an independent panel of 3 sinus surgeons, ESO (VAS 0–100) by the panel, and proportion of patients indicated for RESS based on study criteria. (see “End points” section for details).
Based on the ANCOVA model with baseline value as a covariate and study, site, and treatment group as fixed effects. Values are adjusted for steroid and surgical interventions.
Prespecified secondary end point in RESOLVE II with P adjusted for multiplicity. NO/C score (scale 0–3) based on a daily diary, as reported by Kern et al. 16
Based on the Cochran–Mantel–Haenszel test with study and site as stratification variables.