Table 2.
Efficacy of ocrelizumab in the management of relapsing multiple sclerosis: results of OPERA I and OPERA II [10]
| ARR at week 96 | 12-week CDPa (% of pts) | 24-week CDPa (% of pts) | 12-week CDIb (% of pts) | Mean no. of lesions per MRI scan by week 96 | |||
|---|---|---|---|---|---|---|---|
| Gd+ on T1W | NNEH on T2W | NH on T1W | |||||
| OPERA Ic | |||||||
| Ocrelizumab (n = 410) | 0.16 | 7.6 | 5.9 | 20.0 | 0.02 | 0.32 | 0.42 |
| Interferon β-1a (n = 411) | 0.29 | 12.2 | 9.5 | 12.4 | 0.29 | 1.41 | 0.98 |
| RR/HR (95% CI) or difference (%) |
0.54*** (0.40–0.72) |
0.57 (0.37–0.90) |
0.57 (0.34–0.95) |
61 |
0.06*** (0.03–0.10) |
0.23*** (0.17–0.30) |
0.43*** (0.33–0.56) |
| OPERA IIc | |||||||
| Ocrelizumab (n = 417) | 0.16 | 10.6 | 7.9 | 21.4 | 0.02 | 0.33 | 0.45 |
| Interferon β-1a (n = 418) | 0.29 | 15.1 | 11.5 | 18.8 | 0.42 | 1.90 | 1.26 |
| RR/HR (95% CI) or difference (%) |
0.53*** (0.40–0.71) |
0.63 (0.42–0.92) |
0.63 (0.40–0.98) |
14 |
0.05*** (0.03–0.09) |
0.17*** (0.13–0.23) |
0.36*** (0.27–0.47) |
| Pooled OPERA I and II | |||||||
| Ocrelizumab (n = 827) | NA | 9.1 | 6.9 | 20.7 | NA | NA | NA |
| Interferon β-1a (n = 829) | NA | 13.6 | 10.5 | 15.6 | NA | NA | NA |
| HR (95% CI) or difference (%) | NA |
0.60*** (0.45– 0.81) |
0.60** (0.43–0.84) |
33* | NA | NA | NA |
Primary endpoint (ARR) and MRI secondary endpoints were analysed in the ITT populations of individual trials; secondary endpoints of CDP and CDI were prespecifed to be analysed in the pooled OPERA I and II ITT populations (data from individual trials displayed for completeness)
AAR annualized relapse rate, BL baseline, CDI confirmed disability improvement, CDP confirmed disability progression, EDSS Expanded Disability Status Scale, Gd+ gadolinium-enhancing, HR hazard ratio, MRI magnetic resonance imaging, NA not assessed within hierarchical testing procedure, NH new hypointense, NNEH new or enlarged hyperintense, pts patients, RR rate ratio, T1/2W T1- or T2-weighted MRI scan
*p = 0.02, ** p = 0.003, *** p < 0.001 vs interferon β-1a (displayed for hierarchically assessed primary and secondary endpoints only)
aDisability progression defined as a ≥ 1.0-point increase from BL in EDSS score (or ≥ 0.5-point increase if BL EDSS score > 5.5) sustained for ≥ 12 (12-week CDP) or ≥ 24 weeks (24-week CDP) through week 96
bAssessed in pts with BL EDSS scores ≥ 2.0; disability improvement defined as a ≥ 1.0-point reduction from BL EDSS score (or ≥ 0.5 point if BL EDSS score > 5.5) sustained for ≥ 12 weeks through week 96
cSee text for dosage and regimen details