Table 2.
Baseline Clinical Characteristics for ISAR Patients with Severe Asthma and High Oral Corticosteroid Exposure Who Were and Were Not Initiated on Biologic (Bx) Therapy
| BX Not Initiated | BX Initiated | P-value | B‐H Critical P value Threshold for Significance in Multiple Testing | |
|---|---|---|---|---|
| Age of asthma onset | N=402 | N=876 | 0.150 | 0.057 |
| Mean (SD) | 29.5 (18.7) | 27.9 (18.7) | ||
| Asthma duration | N=394 | N=859 | 0.910 | 0.098 |
| Mean (SD) | 23.8 (16.3) | 23.7 (16.7) | ||
| Asthma control* | N=381 | N=777 | 0.004 | 0.017 |
| Controlled, n (%) | 26 (6.8) | 51 (6.6) | ||
| Partially controlled, n (%) | 76 (20.0) | 98 (12.6) | ||
| Uncontrolled, n (%) | 279 (73.2) | 628 (80.8) | ||
| No. asthma exacerbations in the past year (excluding cases with 0 exacerbations) | N=334 | N=849 | ||
| Mean (SD) | 5.3 (4.0) | 5.7 (3.9) | 0.147 | 0.055 |
| 1, n (%) | 26 (7.8) | 75 (8.8) | 0.009 | 0.024 |
| 2, n (%) | 39 (11.7) | 82 (9.7) | ||
| 3, n (%) | 28 (8.4) | 61 (7.2) | ||
| 4, n (%) | 85 (25.5) | 181 (21.3) | ||
| 5, n (%) | 60 (18.0) | 112 (13.2) | ||
| ≥6, n (%) | 96 (28.7) | 338 (39.8) | ||
| Adherence* | N=327 | N=873 | ||
| Adherent, n (%) | 249 (76.2) | 774 (88.7) | <0.001 | 0.002 |
| Poor: Clinical impression, n (%) | 25 (7.7) | 12 (1.4) | ||
| Poor: Prescription records, n (%) | 53 (16.2) | 87 (10.0) | ||
| Positive allergen test | ||||
| Serum specific IgE test to allergens | N=340 | N=926 | ||
| Positive, n (%) | 112 (32.9) | 396 (42.8) | 0.002 | 0.012 |
| Skin prick test to allergens | N=340 | N=926 | ||
| Positive, n (%) | 99 (29.1) | 305 (32.9) | 0.196 | 0.060 |
| Healthcare resource utilization | ||||
| N=416 | N=996 | |||
| Emergency department visit, N (%) | 157 (37.7) | 321 (32.2) | 0.046 | 0.038 |
| Hospital admission, N (%) | 131 (31.5) | 286 (28.7) | 0.297 | 0.069 |
| Invasive ventilation (ever), N (%) | 27 (6.5) | 69 (6.9) | 0.766 | 0.088 |
| Post-bronchodilator (BD) lung function | ||||
| Post-BD FEV1, % predicted | N=296 | N=840 | ||
| Mean (SD) | 72.69 (23.29) | 73.09 (34.59) | 0.854 | 0.091 |
| Post-BD FEV1/FVC | N=282 | N=826 | 0.008 | 0.022 |
| Mean (SD) | 0.71 (0.18) | 0.67 (0.22) | ||
| Post-BD FEV1/FVC < 0.7, n (%) | N=282 136 (51.8) |
N=826 469 (56.8) |
0.013 | 0.034 |
| Biomarkers | ||||
| Serum total IgE, IU (mL) | N=313 | N=882 | ||
| <150, n (%) | 165 (52.7) | 396 (44.9) | 0.055 | 0.045 |
| 150–400, n (%) | 67 (21.4) | 229 (26.0) | ||
| >400, n (%) | 81 (25.9) | 257 (29.1) | ||
| BEC (/µL) | N=329 | N=919 | ||
| Highest, Mean (SD) | 398.9 (371.4) | 482.8 (468.7) | 0.003 | 0.014 |
| 150, n (%) | 88 (26.8) | 220 (23.9) | 0.057 | 0.047 |
| >150 to ≤ 300, n (%) | 90 (27.4) | 220 (23.9) | ||
| >300 to ≤ 450, n (%) | 43 (13.1) | 99 (10.8) | ||
| >450, n (%) | 108 (32.8) | 380 (41.4) | ||
| FeNO, ppb | N=218 | N=701 | 0.010 | 0.031 |
| <25, n (%) | 87 (39.9) | 205 (29.2) | ||
| 25–50, n (%) | 53 (24.3) | 220 (31.4) | ||
| >50, n (%) | 78 (35.8) | 276 (39.4) | ||
| Low T2 biomarker, n (%) | N=183 | N=666 | ||
| 30 (16.4) | 58 (8.7) | 0.003 | 0.016 | |
| High T2 biomarker, n (%) | N=183 | N=666 | ||
| 75 (41.0) | 282 (42.3) | 0.742 | 0.086 | |
| ISAR gradient eosinophilic phenotype | N=325 | N=911 | <0.001 | 0.003 |
| Grade 0 (unlikely), n (%) | 7 (2.2) | 2 (0.2) | ||
| Grade 1 (least likely), n (%) | 35 (10.8) | 20 (2.2) | ||
| Grade 2 (Likely), n (%) | 62 (19.1) | 62 (6.8) | ||
| Grade 3 (most likely), n (%) | 221 (68.0) | 827 (90.8) | ||
| Co-morbidities | ||||
| Potential OCS-related co-morbidities | ||||
| Anxiety, n (%) | N=230 31 (13.5) |
N=260 36 (13.9) |
0.906 | 0.097 |
| Depression, n (%) | N=227 25 (11.0) |
N=254 23 (9.1) |
0.474 | 0.079 |
| Osteoporosis, n (%) | N=304 52 (17.1) |
N=611 67 (11.0) |
0.009 | 0.026 |
| Peptic ulcer, n (%) | N=185 10 (5.4) |
N=205 6 (2.9) |
0.218 | 0.062 |
| Type II diabetes, n (%) | N=170 31 (18.2) |
N=210 29 (13.8) |
0.239 | 0.064 |
| History of Pneumonia, n (%) | N=184 15 (8.2) |
N=205 16 (7.8) |
0.900 | 0.095 |
| Cataract, n (%) | N=128 9 (7.0) |
N=108 5 (4.6) |
0.437 | 0.076 |
| Embolism, n (%) | N=126 2 (1.6) |
N=105 2 (1.9) |
0.854 | 0.093 |
| Glaucoma, n (%) | N=128 2 (1.6) |
N=108 5 (4.6) |
0.166 | 0.059 |
| Heart failure, n (%) | N=128 3 (2.3) |
=104 1 (1.0) |
0.421 | 0.074 |
| Myocardial infarction, n (%) | N=166 3 (1.8) |
N=148 5 (3.4) |
0.378 | 0.072 |
| Renal failure, n (%) | N=185 2 (1.1) |
N=205 0 (0.0) |
0.136 | 0.053 |
| Sleep apnea, n (%) | N=173 29 (16.8) |
N=231 35 (15.2) |
0.661 | 0.081 |
| Stroke, n (%) | N=166 0 (0.0) |
N=146 1 (0.7) |
0.286 | 0.067 |
| T2 Comorbidities (ever) | N=416 | N=996 | ||
| Allergic rhinitis, n (%) | 168 (40.4) | 313 (31.4) | 0.001 | 0.010 |
| Chronic rhinosinusitis, n (%) | 83 (20.0) | 246 (24.7) | 0.054 | 0.043 |
| Eczema, n (%) | 38 (9.1) | 98 (9.8) | 0.682 | 0.084 |
| Nasal polyps, n (%) | 98 (23.6) | 351 (35.2) | <0.001 | 0.005 |
| Other | ||||
| Anaphylaxis event, n (%) | N=197 5 (2.5) |
N=399 2 (0.5) |
0.030 | 0.036 |
| Cancer event, n (%) | N=199 13 (6.5) |
N=393 8 (2.0) |
0.005 | 0.019 |
| Serious infection event, n (%) | N=196 26 (13.3) |
N=396 194 (49.0) |
<0.001 | 0.009 |
| Asthma therapy | ||||
| Add-on treatment to ICS/LABA | N=416 | N=996 | ||
| Long term OCS, n (%)† | 247 (59.4) | 612 (61.5) | 0.467 | 0.078 |
| LTRA, n (%) | 181 (43.5) | 427 (42.9) | 0.825 | 0.090 |
| Long-term macrolide, n (%) | 25 (6.0) | 54 (5.4) | 0.661 | 0.083 |
| Steroid-sparing, n (%) | 8 (1.9) | 8 (0.8) | 0.070 | 0.050 |
| Theophylline, n (%) | 64 (15.4) | 169 (17.0) | 0.465 | 0.100 |
| LAMA, n(%) | 216 (51.9) | 463 (46.5) | 0.062 | 0.048 |
Notes: *Treatment adherence was evaluated through a mix of methods in different countries in ISAR registry. †LTOCS: OCS therapy for at least 3 months.
Abbreviations: BEC, blood eosinophil count; B-H, Benjamini-Hochberg Procedure; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second; FVC, forced vital capacity; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; IgE, Immunoglobulin E; ISAR, International Severe Asthma Registry; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; SD, standard deviation.