Table 1. Demographic Characteristics and Diagnostic and Baseline Characteristics of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in the Intention-to-Treat Population*.
| Characteristic | Mepolizumab (N = 68) |
Placebo (N = 68) |
|---|---|---|
| Age — yr | 49±12 | 48±14 |
| Male sex — no. (%) | 26 (38) | 30 (44) |
| ANCA-positive status — no. (%)† | 7 (10) | 6 (9) |
| Absolute eosinophil count per cubic millimeter‡ | 177±1.29 | 172±1.35 |
| BVAS >0 — no. (%)§ | 37 (54) | 48 (71) |
| Prednisolone or prednisone dose — mg/day | ||
| Median | 12.0 | 11.0 |
| Range | 7.5–40.0 | 7.5–50.0 |
| Immunosuppressive therapy at baseline — no. (%) | 41 (60) | 31 (46) |
| EGPA diagnostic disease characteristics — no. (%) | ||
| Asthma with eosinophilia | 68 (100) | 68 (100) |
| Biopsy evidence¶ | 25 (37) | 31 (46) |
| Neuropathy‖ | 32 (47) | 24 (35) |
| Nonfixed pulmonary infiltrates | 50 (74) | 48 (71) |
| Sinonasal abnormality | 64 (94) | 64 (94) |
| Cardiomyopathy** | 13 (19) | 7 (10) |
| Glomerulonephritis | 1 (1) | 0 |
| Alveolar hemorrhage | 3 (4) | 1 (1) |
| Palpable purpura | 9 (13) | 8 (12) |
| ANCA-positive status | 13 (19) | 13 (19) |
| Relapsing disease — no. (%) | 51 (75) | 49 (72) |
| Refractory disease — no. (%) | 34 (50) | 40 (59) |
| Duration since diagnosis of EGPA — yr | 5.2±4.4 | 5.9±4.9 |
| Immunosuppressive therapy since diagnosis — no. (%) | 56 (82) | 49 (72) |
Plus–minus values are means ±SD. There were no significant between-group differences at baseline. Demographic characteristics were assessed at visit 2.
Positive antineutrophil cytoplasmic antibody (ANCA) status for myeloperoxidase or proteinase 3 was assessed by means of immunoassay performed at the Covance laboratory and Q2 Solutions.
The absolute eosinophil count is presented as geometric means with standard deviation logs.
The Birmingham Vasculitis Activity Score (BVAS) was assessed on a scale from 0 to 63, with higher scores indicating greater disease activity.
Biopsy evidence was defined as a biopsy specimen showing histopathological evidence of eosinophilic vasculitis, peri-vascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation.
Neuropathy was defined as mononeuropathy or polyneuropathy (motor deficit or nerve-conduction abnormality).
The presence of cardiomyopathy was established by means of echocardiography or magnetic resonance imaging.