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• The study enrolled 732 pwPPMS at sites across the world, including the United States, Canada, Australia, EU countries, Russia, Israel, Mexico, Brazil, and Paraguay. The subjects were randomized 2:1 (ocrelizumab, N=488; placebo, N=244). The subjects received ocrelizumab (dosing regimen of 2 infusions 2-weeks apart) every 24 weeks (ie, every ~6 months).
• Total length of the trial: The trial was event-driven, such that double-blind treatment was administered for a minimum of five doses (120 weeks) until the occurrence in the trial cohort of approximately 253 events of disability progression that was confirmed for at least 12 weeks.
• The primary efficacy outcome measure was percentage of patients with disability progression confirmed at 12 weeks in a time-to-event analysis, in which disability progression was defined as an increase in the EDSS of at least 1.0 point from baseline that was sustained on subsequent visits for at least 12 weeks if the baseline score was 5.5 or less or an increase of at least 0.5 points that was sustained for at least 12 weeks if the baseline score was more than 5.5.
• The secondary outcome measures were percentage of patients with disability progression confirmed at 24 weeks, and other measures such as changes from baseline in T25FW, total volume of brain lesions on T2-weighted MRI, brain volume, and Physical Component Summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36).

• Baseline characteristics: The study population was relatively young, with median age of 46 years for both ocrelizumab (range, 20-56) and placebo (range, 18-56) groups. Approximately 50% were females (ocrelizumab, 48.6%; placebo, 50.8%) and had a wide range of EDSS scores (2.5 to 7.0) with median score of 4.5 in both groups – Note: very similar makeup as in rituximab ORATORIO trial.
• Since the trial was event-driven, the median trial duration was approximately 3 years (ocrelizumab, 2.9 years; placebo, 2.8 years).
• Primary endpoint: The percentage of patients with 12-week CDP were 32.9% with ocrelizumab and 39.3% with placebo (hazard ratio [HR], 0.76; 95% confidence interval [95% CI], 0.59 to 0.98; P=0.03).
• The secondary MRI endpoint, mean change in total volume of T2-weighted lesions from baseline to week 120, was significant in favor of ocrelizumab (p <0.001).
• The changes in all other secondary endpoints were also not significant between the two groups, including 24-week CDP, T25FW, and SF-36 Physical Component Score.
• Safety and tolerability: infusion-related reactions, upper respiratory tract infections, and oral herpes infections were the more frequent adverse events with ocrelizumab than with placebo.

• The primary endpoint was not met (P=0.03).
• However, the authors concluded “In this trial, the results favored ocrelizumab over placebo with respect to the risk of confirmed disability progression at 12 weeks”.

This conclusion is consistent with the observed hazard ratio of 0.76, ie 24% reduction in the risk of disability progression in ocrelizumab group. Note: HR <1 means favors treatment. Furthermore, the reported 95% CI, 0.59 to 0.98, suggests that the best expected response is 41% reduction in disability and the least expected response is 2%. Thus, ocrelizumab may provide clinical benefit in most people with PPMS by slowing the disability progression.

• For context, in the rituximab OLYMPUS trial (different primary endpoint, time to CDP), the HR was 0.77, ie favored rituximab. However, the 95% CI was 0.55 to 1.09, ie in approximately 9% of the pwPPMS, no benefit is expected and rituximab may even harm. (here)
• Reviewing the key Figure from ORATORIO paper (Figure 1, 12-week CDP), it is apparent that the best separation between the curves occur around 3 years. Thus, at least 2-3 years of treatment may be required to see a benefit of ocrelizumab on halting disability progression in PPMS.