Table 2.
Demographic and Baseline Characteristics. a
| Variable |
RESOLVE14,15 |
RESOLVE II 16 |
Pooled analysis b |
|||
|---|---|---|---|---|---|---|
| Treatment (n = 53) | Control (n = 47) | Treatment (n = 201) | Control (n = 99) | Treatment (n = 246) | Control (n = 129) | |
| Age (years) | 47.8 ± 12.6 | 51.6 ± 13.1 | 50.5 ± 12.9 | 47.9 ± 12.4 | 50.0 ± 12.9 | 48.7 ± 12.4 |
| Male subjects, n (%) | 29 (54.7) | 31 (66.0) | 127 (63.2) | 56 (56.6) | 152 (61.8) | 77 (59.7) |
| Ethnicity, n (%) | ||||||
| Not Hispanic or Latino | 49 (92.5) | 46 (97.9) | 190 (94.5) | 92 (92.9) | 232 (94.3) | 121 (93.8) |
| Hispanic or Latino | 4 (7.5) | 1 (2.1) | 11 (5.5) | 7 (7.1) | 14 (5.7) | 8 (6.2) |
| Race, n (%) | ||||||
| White | 47 (88.7) | 44 (93.6) | 164 (81.6) | 80 (80.8) | 204 (82.9) | 107 (82.9) |
| Black or African American | 6 (11.3) | 2 (4.3) | 27 (13.4) | 13 (13.1) | 32 (13.0) | 15 (11.6) |
| Asian | 0 | 1 (2.1) | 4 (2.0) | 4 (4.0) | 4 (1.6) | 5 (3.9) |
| Other | 0 | 0 | 6 (3.0) | 2 (2.0) | 6 (2.4) | 2 (1.6) |
| CRS history, n (%) | ||||||
| Confirmed CRSwNP diagnosis | 53 (100) | 47 (100) | 201 (100) | 99 (100) | 246 (100) | 129 (100) |
| CRS symptoms despite ongoing use of INCS | ||||||
| Nasal obstruction, blockage or congestion | 48 (90.6) | 40 (85.1) | 185 (92.0) | 90 (90.9) | 226 (91.9) | 118 (91.5) |
| Postnasal discharge | 48 (90.6) | 44 (93.6) | 182 (90.5) | 83 (83.8) | 222 (90.2) | 112 (86.8) |
| Altered sense of smell | 42 (79.2) | 39 (83.0) | 174 (86.6) | 89 (89.9) | 210 (85.4) | 115 (89.1) |
| Facial pain, pressure, or fullness | 42 (79.2) | 32 (68.1) | 77 (38.3) | 44 (44.4) | 112 (45.5) | 64 (49.6) |
| ESS history, n (%) | ||||||
| Prior bilateral total ethmoidectomy | 53 (100) | 47 (100) | 201 (100) | 99 (100) | 246 (100) | 129 (100) |
| Number of prior ESS | ||||||
| 1 | 22 (41.5) | 16 (34.0) | 83 (41.3) | 41 (41.4) | 102 (41.5) | 51 (39.5) |
| 2 | 12 (22.6) | 15 (31.9) | 57 (28.4) | 36 (36.4) | 66 (26.8) | 43 (33.3) |
| 3 | 9 (17.0) | 8 (17.0) | 32 (15.9) | 7 (7.1) | 41 (16.7) | 13 (10.1) |
| 4 and more | 10 (18.9) | 8 (17.0) | 29 (14.4) | 15 (15.2) | 37 (15.0) | 22 (17.1) |
| Medical history, n (%) c | ||||||
| Asthma | 33 (62.3) | 31 (66.0) | 148 (73.6) a | 61 (61.6) | 179 (72.8) | 83 (64.3) |
| Allergic rhinitis | 41 (77.4) | 37 (78.7) | 155 (77.1) | 79 (79.8) | 189 (76.8) | 102 (79.1) |
| Aspirin intolerance/allergy | 15 (28.3) | 11 (23.4) | 46 (22.9) | 23 (23.2) | 60 (24.4) | 33 (25.6) |
| AERD | 11 (20.8) | 9 (19.1) | 30 (14.9) | 17 (17.2) | 40 (16.3) | 25 (19.4) |
Abbreviations: AERD, aspirin-exacerbated respiratory disease; CRS, chronic rhinosinusitis; CRSwNP, chronic rhinosinusitis with nasal polyps; ESS, endoscopic sinus surgery; INCS, intranasal corticosteroid spray; NP, nasal polyps; RESS, revision ESS; SD, standard deviation.
a
Values are means ± SD or as indicated. Treatment groups did not differ significantly, except in incidence of asthma in RESOLVE II (P = .0336).
b
Analysis of the pooled data from RESOLVE and RESOLVE II for patients with NP grade ≥ 2 on each side at screening and confirmed candidacy for RESS.
c
Medical history based on physician diagnosis as recorded in patient medical records.