- Wolinsky JS, et al. Sustained reduction in 48-week confirmed disability progression in patients with PPMS treated with ocrelizumab in the ORATORIO OLE: 8-year follow-up. OP158, ECTRIMS 2021 Virtual Congress, 13—15 October.
Ocrelizumab outperformed placebo in patients with PPMS in the 144-week double-blind plus extended controlled periods of the randomised, controlled phase 3 ORATORIO trial. The OLE of this trial assessed the long-term efficacy and safety of ocrelizumab for patients (n=517) maintaining or switching (prior placebo receivers) to ocrelizumab therapy.
Time to the first 48-week confirmed disability progression (CDP) on the Expanded Disability Status Scale (EDSS) of ≥ 1 point (in patients with EDSS ≤ 5.5 at baseline), or ≥ 0.5 points (in patients with EDSS > 5.5 at baseline) was the primary endpoint of this trial. Dr Jerry Wolinsky (University of Texas Health Science Center at Houston, TX, USA) presented the 8-year follow-up study results. At week 48, initial ocrelizumab users displayed fewer 48-week CDP-EDSS events (55.85%) than delayed treatment receivers (67.48%).
Combining all periods of the study, the reduced risk of CDP-EDSS events was 29% for ocrelizumab users. The risk of repeated 48-week CDP-EDSS events was lower in ocrelizumab receivers as well: the mean cumulative number of repeated CDP-EDSS was 0.9443 in early ocrelizumab users versus 1.2069 in delayed ocrelizumab users. Over 8 years, the risk of achieving 48-week CDP-EDSS score of ≥ 7, representing wheelchair dependence, was numerically lower (33%) in initial ocrelizumab subjects.