Table 2.
Demographic and Clinical Characteristics of Patients with Severe Asthma Enrolled into ISAR or CHRONICLE, Prior to First Biologic, According to Pattern of First Biologic Use
| Biologic Utilisation Group | Continued 2791 | Stopped 356 | Switched 384 | Stoppers vs Continuers: P-valuea | Switchers vs Continuers: P-valuesa |
|---|---|---|---|---|---|
| Demographics | |||||
| Age categories, years | 2776 | 350 | 379 | 0.086 | 0.065 |
| 18–34, n (%) | 312 (11.2) | 54 (15.4) | 50 (13.2) | ||
| 35–54, n (%) | 1054 (38.0) | 121 (34.6) | 164 (43.3) | ||
| 55–79, n (%) | 1352 (48.7) | 165 (47.1) | 157 (41.4) | ||
| ≥80, n (%) | 58 (2.1) | 10 (2.9) | 8 (2.1) | ||
| Sex | 2787 | 356 | 383 | 0.916 | 0.154 |
| Male | 1002 (36.0) | 129 (36.2) | 152 (39.7) | ||
| Female | 1785 (64.0) | 227 (63.8) | 231 (60.3) | ||
| Ethnicity | 2724 | 355 | 378 | 0.701 | 0.310 |
| Caucasian, n (%) | 2147 (78.8) | 280 (78.9) | 283 (74.9) | ||
| Asian, n (%) | 73 (2.7) | 9 (2.5) | 13 (3.4) | ||
| African, n (%) | 221 (8.1) | 34 (9.6) | 39 (10.3) | ||
| Mixed/Other/Unknown, n (%) | 283 (10.4) | 32 (9.0) | 43 (11.4) | ||
| Smoking status | 1292 | 240 | 172 | 0.804 | 0.876 |
| Current smoker, n (%) | 24 (1.9) | 6 (2.5) | 4 (2.3) | ||
| Ex-smoker, n (%) | 356 (27.6) | 66 (27.5) | 49 (28.5) | ||
| Never Smoked, n (%) | 912 (70.6) | 168 (70.0) | 119 (69.2) | ||
| Age of asthma onset, years | 2057 | 125 | 261 | 0.560 | 0.959 |
| <12, n (%) | 521 (25.3) | 37 (29.6) | 64 (24.5) | ||
| ≥12–29, n (%) | 510 (24.8) | 30 (24.0) | 65 (24.9) | ||
| ≥30, n (%) | 1026 (49.9) | 58 (46.4) | 132 (50.6) | ||
| BMI Category | 1306 | 261 | 188 | 0.295 | 0.590 |
| Underweight, n (%) | 25 (1.9) | 6 (2.3) | 3 (1.6) | ||
| Normal weight, n (%) | 368 (28.2) | 68 (26.1) | 48 (25.5) | ||
| Overweight, n (%) | 425 (32.5) | 74 (28.4) | 57 (30.3) | ||
| Obese, n (%) | 488 (37.4) | 113 (43.3) | 80 (42.6) | ||
| Comorbidities | |||||
| Allergic Rhinitis | 514 | 109 | 77 | 0.026 | 1.000 |
| Ever, n (%) | 467 (90.9) | 106 (97.2) | 70 (90.9) | ||
| Eczema | 676 | 55 | 67 | 0.608 | 0.493 |
| Ever, n (%) | 32 (4.7) | 4 (7.3) | 5 (7.5) | ||
| CRS and NP | 684 | 73 | 101 | <0.001 | 0.020 |
| CRSwNP, n (%) | 411 (60.1) | 28 (38.4) | 63 (62.4) | ||
| eCRS, n (%) | 75 (11.0) | 28 (38.4) | 20 (19.8) | ||
| CRSsNP, n (%) | 27 (3.9) | 12 (16.4) | 3 (3.0) | ||
| None | 171 (25.0) | 5 (6.8) | 15 (14.9) | ||
| Biomarkers | |||||
| BEC (cells/μL)# | 865 | 166 | 153 | ||
| Not on long-term OCS | 771 | 150 | 134 | 0.411 | 0.011 |
| <300, n (%) | 326 (42.3) | 58 (38.7) | 41 (31.1) | ||
| ≥300, n (%) | 445 (57.7) | 92 (61.3) | 93 (68.9) | ||
| On long-term OCS | 94 | 16 | 18 | 0.064 | 0.083 |
| <300, n (%) | 47 (50.0) | 4 (25.0) | 5 (27.8) | ||
| ≥300, n (%) | 47 (50.0) | 12 (75.0) | 13 (72.2) | ||
| FeNO (ppb) | 795 | 126 | 94 | 0.663 | 0.007 |
| 0-<25, n (%) | 357 (44.9) | 62 (49.2) | 28 (29.8) | ||
| ≥25 - <50, n (%) | 250 (31.4) | 37 (29.4) | 32 (34.0) | ||
| ≥50, n (%) | 188 (23.6) | 27 (21.4) | 34 (36.2) | ||
| IgE Concentration (IU/mL) | 1417 | 207 | 209 | 0.158 | 0.462 |
| <150, n (%) | 601 (42.4) | 80 (38.6) | 83 (39.7) | ||
| ≥150 - <400, n (%) | 388 (27.4) | 70 (33.8) | 54 (25.8) | ||
| ≥400, n (%) | 428 (30.2) | 57 (27.5) | 72 (34.4) | ||
| Medication | |||||
| Long-term OCS# | 1950 | 307 | 260 | 0.007 | 0.516 |
| Use, n (%) | 228 (11.7) | 20 (6.5) | 34 (13.1) | ||
| Add on therapy# | 1950 | 307 | 260 | ||
| LAMA, n (%) | 326 (16.7) | 38 (12.4) | 33 (12.7) | 0.055 | 0.098 |
| Theophylline, n (%) | 26 (1.3) | 6 (2.0) | 10 (3.8) | 0.392 | 0.003 |
| LTRA, n (%) | 224 (11.5) | 19 (6.2) | 24 (9.2) | 0.005 | 0.279 |
| Exacerbations# | |||||
| 728 | 46 | 73 | |||
| Not on long-term OCS, n (%) | 503 (69.1) | 39 (84.8) | 62 (84.9) | 0.002 | 0.004 |
| Median (IQR) | 4.0 (2, 6) | 5.0 (4, 8) | 4.5 (3, 8) | ||
| On long-term OCS, n (%) | 101 (13.9) | 0 (0.0) | 8 (11.0) | Nc | 0.802 |
| Median (IQR) | 2.0 (2, 4) | - | 2.5 (2, 6) | ||
| Healthcare resource utilization | |||||
| Invasive Ventilation Episodes | 715 | 42 | 67 | 0.002 | 0.079 |
| ≥1, n (%) | 45 (6.3) | 8 (19.0) | 8 (11.9) | ||
| Emergency Visits# | 450 | 47 | 65 | 0.142 | 0.010 |
| ≥1, n (%) | 180 (40.0) | 24 (51.1) | 37 (56.9) | ||
| Hospitalizations# | 639 | 45 | 63 | 0.004 | <0.001 |
| ≥1, n (%) | 136 (21.3) | 18 (40.0) | 29 (46.0) | ||
| Lung function | |||||
| Post-bronchodilator percentage predicted FEV1 | 1247 | 220 | 191 | 0.733 | 0.794 |
| <80%, n (%) | 659 (52.8) | 119 (54.1) | 99 (51.8) | ||
| ≥80%, n (%) | 588 (47.2) | 101 (45.9) | 92 (48.2) | ||
| Post-bronchodilator FEV1:FVC | 1260 | 219 | 194 | 0.064 | 0.116 |
| <0.7, n (%) | 503 (39.9) | 102 (46.6) | 89 (45.9) | ||
| ≥0.7, n (%) | 757 (60.1) | 117 (53.4) | 105 (54.1) | ||
Notes: #Variable that was further restricted to data ONLY within the 12 months preceding biologic therapy. aP-values from Pearson chi-square tests, applying Yates correction when the expected frequency was less than 5 in more than 20% of the sub-categories, for all variables except for exacerbation counts which were compared using the Wilcoxon score test.
Abbreviations: BEC, blood eosinophil count; CRSsNP, chronic rhinosinusitis without nasal polyps; CRSwNP, chronic rhinosinusitis with nasal polyps; eCRS, eosinophilic chronic rhinosinusitis; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second; FVC, forced vital capacity; IgE, Immunoglobulin E; IQR, inter-quartile range; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; NC, Not calculated (no patients on long-term OCS stopped their initial biologic).