Baseline characteristics of the intention-to-treat population†
| Mavrilimumab‡ (n=42) | Placebo (n=28) | |
| Age (years) | 69.7 (7.0) | 69.7 (8.3) |
| Sex | ||
| Male | 10 (24%) | 10 (36%) |
| Female | 32 (76%) | 18 (64%) |
| Race | ||
| White | 40 (95%) | 28 (100%) |
| Other | 2 (5%) | 0 |
| Hispanic or Latino ethnicity | 1 (2%) | 2 (7%) |
| Weight (kg) | 70.9 (18.7) | 71.1 (12.0) |
| Body mass index (kg/m2) | 26.2 (6.8) | 26.1 (3.6) |
| Prior treatment | ||
| Glucocorticoids | 42 (100%) | 27 (96%) |
| Methotrexate | 0 | 1 (4%) |
| Diagnostic confirmation | ||
| By positive temporal artery biopsy | 22 (52%) | 9 (32%) |
| By positive imaging | 29 (69%) | 22 (79%) |
| Time since diagnosis (months) | 7.9 (15.4) | 9.8 (21.8) |
| Giant-cell arteritis | ||
| New onset* | 24 (57%) | 11 (39%) |
| Relapsing/refractory* | 18 (43%) | 17 (61%) |
| Giant-cell arteritis type | ||
| Cranial signs or symptoms | 32 (76%) | 21 (75%) |
| Extracranial signs or symptoms | 9 (21%) | 6 (21%) |
| C reactive protein level (study eligibility value) (mg/dL) | 4.7 (4.7) | 3.6 (3.2) |
| Erythrocyte sedimentation rate (study eligibility value) (mm/hour) | 57.0 (24.6) | 55.1 (30.2) |
| Prednisone starting dose | ||
| ≤30 mg | 16 (38.1) | 14 (50.0) |
| >30 mg | 26 (61.9) | 14 (50.0) |
Data are n (%) or mean (SD).
*Seven patients were misstratified due to investigator error (new onset vs relapsing/refractory misclassification) at study entry. For the efficacy analysis, these patients were included in the appropriate protocol-defined subgroups, leading to a proportion of 57% of patients with new-onset disease in the mavrilimumab group (43% relapsing/refractory) and 39% of patients with new-onset disease in the placebo group (61% relapsing/refractory).
†Baseline is last assessment within 3 days before the first dose of mavrilimumab or placebo.
‡150 mg subcutaneously every 2 weeks.