Demographics and baseline characteristics [pooled SINUS-24/-52 studies, subgroup of patients with nasal polyp score (NPS) = 8 and intention-to-treat (ITT) population]
| Characteristic | Patients with NPS = 8(n = 98) | ITT population(n = 724) |
|---|---|---|
| Age, years | 53.8 (13.2) | 51.4 (12.8) |
| Male sex, n (%) | 55 (56) | 437 (60) |
| Region, n (%) | ||
| Asia | 8 (8) | 49 (7) |
| Latin America | 29 (30) | 137 (19) |
| East Europe | 22 (22) | 216 (30) |
| Western countries | 39 (40) | 322 (44) |
| Time since first NP diagnosis, years | 13.5 (10.9) | 11.0 (9.5) |
| Prior NP surgery, n (%) | 58 (59) | 459 (63) |
| Time since most recent surgery, years | 10.1 (6.9) | 7.2 (6.4) |
| Number of previous surgeries, n (%)* | ||
| 1 | 36 (62) | 254 (55) |
| 2 | 8 (14) | 94 (20) |
| ≥ 3 | 14 (24) | 111 (24) |
| SCS use in past 2 years, n (%) | 82 (84) | 538 (74) |
| Asthma, n (%) | 59 (60) | 428 (59) |
| NSAID-ERD, n (%) | 32 (33) | 204 (28) |
| NPS (0–8) | 8.0 (0.0) | 6.0 (1.3) |
| NC score (0–3) | 2.7 (0.4) | 2.4 (0.6) |
| LMK-CT total score (0–24) | 18.9 (3.9) | 18.4 (4.1) |
| LoS score (0–3) | 2.9 (0.3) | 2.7 (0.5) |
| Anterior rhinorrhea (0–3) | 2.4 (0.6) | 2.1 (0.7) |
| Posterior rhinorrhea (0–3) | 2.3 (0.8) | 2.0 (0.8) |
| TSS (0–9) | 8.0 (1.2) | 7.2 (1.4) |
| Rhinosinusitis VAS (0–10) | 8.3 (2.2) | 7.9 (2.1) |
| UPSIT score (0–40) | 11.5 (6.3) | 14.0 (8.2) |
| UPSIT anosmia†, n (%) | 88 (91)‡ | 551 (78)‡ |
| SNOT-22 total score (0–110) | 56.9 (21.6) | 50.9 (20.7) |
| PNIF (L/min) | 33.8 (45.1) | 87.1 (56.1) |
| PNIF group (L/min), n (%) | ||
| < 97.5 | 93 (94.9) | 453 (62.6) |
| ≥ 97.5–< 138.4 | 2 (2.0) | 150 (20.7) |
| ≥ 138.4 | 3 (3.1) | 121 (16.7) |
All data are mean (standard deviation) unless otherwise stated. * Percentages calculated using number of patients with surgery as denominator; † UPSIT < 18; ‡ n = 97 (NPS = 8 population), n = 710 (ITT population). SCS: systemic corticosteroids; NSAID-ERD: nonsteroidal anti-inflammatory drug-exacerbated respiratory disease; NC: nasal congestion/obstruction; LMK-CT: Lund-Mackay computed tomography; LoS: loss of smell; TSS: total symptom score; VAS: visual analog scale; UPSIT: University of Pennsylvania Smell Identification Test; SNOT-22: 22-item Sinonasal Outcome Test; PNIF: peak nasal inspiratory flow