Table 2.
Clinical and MRI endpoints during the trial.
| Endpoint | Xacrel (N = 85) | Ocrevus (N = 85) | P-Value |
|---|---|---|---|
| Primary endpoint | |||
| Annualized relapse rate at 48 weeks (PP)** | 0.067 (0.029 to 0.155) | 0.070 (0.031 to 0.158) | |
| Rate difference (95% CI) | 0.002 (− 0.080 to 0.075) | 0.95 | |
| Annualized relapse rate at 48 weeks (ITT) | 0.065 (0.028 to 0.149) | 0.068 (0.030 to 0.153) | |
| Rate difference (95% CI) | − 0.003 (− 0.078 to 0.072) | 0.95 | |
| Secondary clinical endpoints | |||
| Disability progression confirmed at 12 weeks¥ | |||
| Patients with event (%) | 6 (7.06) | 5 (5.90) | |
| Hazard ratio (95% CI) | 1.25 (0.38 to 4.10) | 0.71 | |
| Disability progression confirmed at 24 weeks¥ | |||
| Patients with event (%) | 6 (7.06) | 2 (2.35) | |
| Hazard ratio (95% CI) | 3.15 (0.64 to 15.60) | 0.16 | |
| Proportion of relapse-free patients by Week 96 (%) | 76 (89.41) | 74 (87.10) | 0.63 |
| Secondary MRI endpoints | |||
| Total no. of new or newly enlarged hyperintense lesions on T2-weighted MRI by week 96§ | |||
| Mean no. of lesions per scan (95% CI) | 0.16 (0.08 to 0.33) | 0.08 (0.03 to 0.20) | |
| Rate ratio (95% CI) | 1.98 (0.70 to 5.73) | 0.21 | |
| T2-volume change from baseline to week 96 | − 0.60 (5.94) | − 0.70 (2.60) | 0.88 |
| Exploratory endpoints | |||
| Annualized relapse rate at 96 weeks | 0.112 (0.041 to 0.184) | 0.124 (0.049 to 0.198) | |
| Rate difference (95% CI) | − 0.011 (− 0.113 to 0.089) | 0.82 | |
| Proportion of patients experiencing CD19 levels of less than 1% at least once (%) | 55 (64.71) | 54 (63.53) | 0.87 |
CI confidence Interval, ITT intention to treat, MRI magnetic resonance imaging, PP per protocol.
*All rate ratios, hazard ratios, and rate difference values are for the Xacrel versus the Ocrevus.
**Per protocol set (81 patients in the Xacrel group and 83 patients in the Ocrevus group).
¥Disability progression that was confirmed at 12 or 24 weeks was defined as an increase from the baseline EDSS score of at least 1.5 score if the baseline value was zero; at least 1 score increase in EDSS if 0 < baseline EDSS ≤ 5.5 and at least 0.5 score increase in EDSS if the baseline EDSS > 5.5, that was sustained for at least 12 or 24 weeks.
§The total number of lesions was calculated as the sum of the individual number of lesions at weeks 24, 48, and 96, divided by the total number of MRI scans of the brain.