Ocrelizumab shows long-term benefits in primary progressive MS

Patients with primary progressive MS (PPMS) who were originally receiving ocrelizumab had a lower risk of disability progression than patients originally receiving placebo after 8-years of follow-up, despite later cross-over in the open-label extension (OLE) period of the phase 3 ORATORIO trial. In addition, patients originally receiving ocrelizumab had a significantly reduced rate of recurrent 48-week confirmed disability progression (CDP) events, compared with participants who received ocrelizumab only later in the trial [1].

Ocrelizumab outperformed placebo in patients with PPMS in the 144-week, double-blind plus extended controlled periods of the randomised, phase 3 ORATORIO trial (NCT01194570). 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. The primary endpoint of this trial was time to first 48-week 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). Prof. Jerry S. Wolinsky (University of Texas Health Science Center at Houston, TX, USA) presented the 8-year follow-up study results.

At week 408, initial ocrelizumab users displayed fewer 48-week CDP-EDSS events (55.9%) than delayed treatment receivers (67.5%). Combining all periods of the study, the reduced risk of CDP-EDSS events was 29% for patients receiving ocrelizumab from the start. 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 0.944 in early ocrelizumab users versus 1.207 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 subjects receiving ocrelizumab at the start.

In summary, compared with a delayed ocrelizumab start, early treatment significantly reduced patients’ risk of CDP-EDSS. Early ocrelizumab receivers’ need for walking aid was reduced by approximately a third as well. In short, a 2-year delay in initiating ocrelizumab “comes at a cost to patients,” suggesting a clear benefit for clinicians to start this therapy from the get-go.

1. 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.

 

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Posted on 9 December 202125 March 2024