Table 2.
Primary end point and key secondary end points
| End point | Mavrilimumab** | Placebo | HR or difference | P value* |
| All study patients† | (N=42) | (N=28) | − | − |
| Patients with flare | 8 (19.0%) | 13 (46.4%) | − | − |
| Time to flare (primary end point)—week | NE (NE, NE) | 25.1 (16.0 to NE) | 0.38 (0.15 to 0.92)‡ | 0.026 |
| Sustained remission§—% | 83.2 (67.9 to 91.6) | 49.9 (29.6 to 67.3) | 33.3 (10.7 to 55.8)¶ | 0.0038 |
| Patients with new-onset† giant-cell arteritis at baseline |
(N=24) | (N=11) | − | − |
| Patients with flare | 3 (12.5%) | 4 (36.4%) | − | − |
| Time to flare—week | NE (NE to NE) | NE (11.7 to NE) | 0.29 (0.06 to 1.31)‡ | − |
| Sustained remission§—% | 91.3 (69.3 to 97.7) | 62.3 (27.7 to 84.0) | 28.9 (−2.7 to 60.5)¶ | − |
| Patients with relapsing/refractory† giant-cell arteritis at baseline |
(N=18) | (N=17) | − | − |
| Patients with flare | 5 (27.8%) | 9 (52.9%) | − | − |
| Time to flare—week | NE (16.4 to NE) | 22.6 (16.0 to NE) | 0.43 (0.14 to 1.30)‡ | − |
| Sustained remission§—% | 72.2 (45.6 to 87.4) | 41.7 (17.4 to 64.5) | 30.6 (−2.1 to 63.2)¶ | − |
Data are n (%) or median (95% CI), except as indicated.
*P values are two sided.
†Modified intention-to-treat (mITT) population.
‡Calculated using a Cox proportional hazards model with treatment as covariate.
§The Kaplan-Meier method was used to estimate event rates. In some cases, results were NE because the event rates were too low.
¶Calculated as the difference in sustained remission between the two groups using normal approximation with placebo as the reference.
**150 mg subcutaneously every 2 weeks.
NE, not estimable.