TABLE 2.
Treatment effect comparisons on CRSwNP disease control, airway function, and sense of smell at Week 24 in patients with CRSwNP with and without NSAID‐ERD (SINUS‐24 and SINUS‐52 pooled)
|
Characteristics/ Parameters |
Patients with CRSwNP with NSAID‐ERD | Patients with CRSwNP without NSAID‐ERD | Overall interaction p‐value in patients with CRSwNP with/without NSAID‐ERD b |
|---|---|---|---|
| LS mean difference versus placebo (95% CI), p‐value versus placebo a | LS mean difference versus placebo (95% CI), p‐value versus placebo a | ||
| NPS score, range 0–8 |
–1.89 (–2.30, –1.49) < .0001 |
–1.92 (–2.20, –1.64) < .0001 |
.9786 |
| NC score, range 0–3 |
–1.17 (–1.39, –0.95) < .0001 |
–0.77 (–0.92, –0.63) < .0001 |
.0044 |
| LMK‐CT score, range 0–24 |
–6.33 (–7.39, –5.27) < .0001 |
–6.04 (–6.69, –5.40) < .0001 |
.5637 |
| SNOT‐22 score, range 0–110 |
–24.35 (–29.54, –19.17) < .0001 |
–16.80 (–19.91, –13.69) < .0001 |
.0313 |
| TSS, range 0–9 |
–3.01 (–3.53, –2.49) < .0001 |
–2.32 (–2.70, –1.95) < .0001 |
.0425 |
| Rhinosinusitis (VAS), range 0–10 |
–3.59 (–4.30, –2.87) < .0001 |
–2.84 (–3.32, –2.37) < .0001 |
.2354 |
| UPSIT score, range 0–40 |
10.17 (7.95, 12.39) < .0001 |
10.69 (9.32, 12.07) < .0001 |
.8548 |
| Daily loss of smell score, range 0–3 |
–1.01 (–1.23, –0.79) < .0001 |
–1.05 (–1.20, –0.89) < .0001 |
.9338 |
| SNOT‐22 decreased smell/taste score |
–2.12 (–2.54, –1.70) < .0001 |
–1.92 (–2.18, –1.66) < .0001 |
.5352 |
| FEV1,c L |
0.26 (0.15, 0.36) < .0001 |
0.19 (0.08, 0.30) .001 |
.3434 |
| ACQ‐6 score,c range 0–6 |
–0.97 (–1.22, –0.72) < .0001 |
–0.72 (–0.92, –0.52) < .0001 |
.1630 |
| PNIF, L/min |
52.05 (39.71, 64.40) < .0001 |
33.11 (25.48, 40.74) < .0001 |
.0123 |
Abbreviations: ACQ‐6, six‐item Asthma Control Questionnaire; ANCOVA, analysis of covariance; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; FEV1, forced expiratory volume in 1 second; LMK‐CT, Lund–Mackay computed tomography; LS, least squares; MI, multiple imputation; NC, nasal congestion; NPS, nasal polyp score; NSAID‐ERD, non‐steroidal anti‐inflammatory drug‐exacerbated disease; PNIF, peak nasal inspiratory flow; SNOT‐22, 22‐item Sinonasal Outcome Test; TSS, Total Symptom Score; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale; WOCF, worst observation carried forward.
Each of the imputed complete data was analyzed by fitting an ANCOVA model with change from baseline at the corresponding visit as the response variable, and the corresponding baseline value, treatment group, prior surgery history, region, and study indicator (SINUS‐52 = 0 and SINUS‐24 = 1) as covariates. Analysis was based on the same imputed dataset using WOCF/MI from primary analysis of the endpoint in each of the two studies (SINUS‐52 and SINUS‐24).
Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, NSAID‐ERD status, prior surgery history, region, NSAID‐ERD status‐by‐treatment interaction, and study indicator (SINUS‐52 = 0 and SINUS‐24 = 1) as covariates.
Analyzed in patients with asthma only.