Table 3.
Efficacy of ocrelizumab in the management of primary progressive multiple sclerosis: results of ORATORIO [16]
| 12-week CDPa (% of pts) | 24-week CDPa (% of pts) | T25FW performance (% Δb from BL to week 120) | T2W lesion volume (% Δb from BL to week 120) | Brain volume (% Δb from week 24 to 120) | SF-36 PCS score (Δb from BL to week 120) | |
|---|---|---|---|---|---|---|
| Ocrelizumabc (n = 488) | 32.9 | 29.6 | 38.9 | − 3.37 | − 0.90 | − 0.7 |
| Placeboc (n = 244) | 39.3 | 35.7 | 55.1 | 7.43 | − 1.09 | − 1.1 |
| HR or relative difference (95% CI) | 0.76* (0.59 to 0.98) | 0.75* (0.58 to 0.98) | 29.3* (− 1.6 to 51.5) | 0.90** (0.88 to 0.92) | 17.5* (3.2 to 29.3) | 0.38 (− 1.05 to 1.80) |
Primary (12-week CDP) and secondary endpoints, analysed in the intention-to-treat population and assessed hierarchically in order displayed
BL baseline, CDP confirmed disability progression, HR hazard ratio, pts patients, SF-36 PCS 36-Item Short-Form Health Survey Physical Component Summary, T25FW timed 25-foot walk, T2W T2-weighted MRI scan, Δ change
*p < 0.05, **p < 0.001 vs placebo
aDisability progression defined as a ≥ 1.0-point increase from BL in EDSS score (or ≥ 0.5-point increase if BL score > 5.5) sustained for ≥ 12 weeks (12-week CDP) or ≥ 24 weeks (24-week CDP)
bMean percent Δ (T25FW; brain volume), adjusted geometric mean percent Δ (total T2 lesion volume) or adjusted mean Δ (SF-36 PCS score)
cSee text for dosage and regimen details