Table 1.
Baseline patient and disease characteristics
| Omalizumab study, N = 46 (unless otherwise stated) | Ciclosporin study, N = 72 (unless otherwise stated) | |
|---|---|---|
| Sex | ||
| Male | 10 (22%) | 11 (15%) |
| Female | 36 (78%) | 61 (85%) |
| Age (years) | ||
| <20 | 0 | 3 (4%) |
| 20–29 | 10 (22%) | 12 (17%) |
| 30–39 | 6 (13%) | 16 (22%) |
| 40–49 | 16 (35%) | 28 (39%) |
| 50–59 | 8 (17%) | 7 (10%) |
| 60–69 | 5 (11%) | 4 (6%) |
| 70–79 | 1 (2%) | 2 (3%) |
| Mean (SD) | 43.3 (13.1) | 40.5 (12.8) |
| Weight (kg) | n = 21 | n = 24 |
| Mean (SD) | 85.3 (27.1) | 78.8 (16.2) |
| Diagnosis | ||
| CSU only | 36 (78%)a | 66 (92%) |
| CSU + CIndU | 10 (22%)a | 6 (8%) |
| History of angioedema | ||
| All patients | 38 (83%) | 50 (69%) |
| CSU only | 31 (86%) | 45 (68%) |
| CSU + CIndU | 7 (70%) | 5 (83%) |
| Co-morbidities (not mutually exclusive) | ||
| None | 13 (28%) | 43 (60%) |
| Allergic condition | 9 (20%) | 10 (14%) |
| Hypertension | 8 (17%) | 6 (8%) |
| Asthma | 7 (15%) | 0c |
| Eczema | 7 (15%) | 0c |
| Thyroid disorder | 3 (7%) | 2 (3%) |
| Depression | 5 (11%) | 4 (6%) |
| Anxiety | 1 (2%) | 4 (6%) |
| Other | 17 (37%)b | 16 (22%)b |
| Time since first symptoms (years) | N = 42 | N = 57 |
| <1 | 0 | 12 (21%) |
| 1 < 5 | 15 (36%) | 25 (44%) |
| 5 < 10 | 16 (38%) | 10 (18%) |
| ≥10 | 11 (26%) | 10 (18%) |
| Not recorded | 4 | 15 |
| Median (IQR) | 7.2 (3.7–10.0) | 3.2 (1.5–7.6) |
| Time since diagnosis (years) | N = 37 | N = 51 |
| <0.5 | 0 | 31 (61%) |
| 0.5 < 1 | 6 (16%) | 11 (22%) |
| 1 < 5 | 17 (46%) | 9 (18%) |
| 5 < 10 | 12 (32%) | 0 |
| ≥10 | 2 (5%) | 0 |
| Not recorded | 9 | 21 |
| Median (IQR) | 3.8 (1.2–7.5) years | 3.7 (2.3–9.1) months |
| Previous 2nd/3rd line CSU medications (not mutually exclusive) | ||
| 2nd line | ||
| Montelukast | 23 (50%) | 19 (16%) |
| Dapsone | 12 (26%) | 3 (4%) |
| H2-antihistamine | 10 (22%) | 8 (11%) |
| Sulphasalazine | 7 (15%) | 1 (1%) |
| Hydroxychloroquine | 8 (17%) | 1 (1%) |
| 3rd line | ||
| Ciclosporin | 33 (72%) | – |
| Omalizumab | – | 0 |
| Methotrexate | 17 (37%) | 1 (1%) |
| Azathioprine | 15 (33%) | 4 (6%) |
| Mycophenolate mofetil | 12 (26%) | 2 (3%) |
| Tacrolimus | 2 (4%) | 0 |
| Any 3rd line | 39 (85%) | 7 (10%) |
| Others | ||
| UVB light therapy | 1 (2%) | 0 |
| Rituximab | 1 (2%) | 0 |
| Cyclophosphamide | 1 (2%) | 0 |
| Colchicine | 3 (7%) | 0 |
| Antidepressant | 12 (26%) | 6 (8%) |
| Corticosteroids in previous 12 months | 29 (74%) (n = 39) | 18 (29%) (n = 63) |
| CSU severity and QoL | ||
| UAS7 Score | n = 27 | |
| 0 | 0 | – |
| 1–6 (well controlled) | 1 (4%) | – |
| 7–15 (mild disease) | 2 (7%) | – |
| 16–27 (moderate disease) | 10 (37%) | – |
| 28–42 (severe disease) | 14 (52%) | – |
| Mean (SD) | 27.5 (10.4) | – |
| Median (IQR) | 29.0 (20.7–36.1) | – |
| DLQI Score | n = 32 | n = 20 |
| 0–1 (disease no impact on QoL) | 0 | 0 |
| 2–5 (small impact) | 3 (9%) | 0 |
| 6–10 (moderate impact) | 1 (3%) | 1 (5%) |
| 11–20 (large impact) | 9 (28%) | 13 (65%) |
| 21–30 (extremely large impact) | 19 (59%) | 6 (30%) |
| Mean (SD) | 19.5 (7.1) | 17.4 (6.6) |
| Median (IQR) | 21.5 (15.0–24.0) | 16.5 (12.0–22.0) |
Only data that were recorded in the notes are included so the totals for each field are different for most characteristics.
aTwo patients showed features of urticarial vasculitis (UV) during their recorded medical history.
bOther co-morbidities (not specified in the study DCF) in omalizumab study patients were: Diabetes, 3; Chronic fatigue, 2; Obesity, 2; PVD, 2; osteoporosis/osteopenia, 2; COPD, inflammatory bowel disease, adrenal insufficiency, cardiovascular disease, renal transplant, haemophilia, sarcoidosis, inflammatory arthritis (×1 each). Other co-morbidities (not specified in the study DCF) in ciclosporin study patients were: Diabetes, 4; Autoimmune disorder, 3; Cardiovascular disease, 2 and IBS, Ovarian cysts/fibroids, Cancer, COPD, Chronic fatigue syndrome, pancreatitis, mastitis, stroke/TIA, PE, gall stones, sinusitis and facial nerve palsy (×1 each).
cPatients with asthma or eczema were excluded from the ciclosporin study.