PO127 Composite confirmed disability progression in oratorio

2017 
Background Ocrelizumab significantly reduced the risk of confirmed disability progression (CDP) versus placebo in the Phase III ORATORIO study (NCT01194570) in primary progressive multiple sclerosis (PPMS). A composite measure of CDP (cCDP) that also includes upper extremity function and ambulation speed may address limitations in using the Expanded Disability Status Scale to define CDP. Objective To assess the effect of ocrelizumab on 12- and 24 week cCDP in patients with PPMS. Methods Patients received ocrelizumab (n=488) 600 mg (administered as two 300 mg infusions 14 days apart) or matching placebo (n=244) every 24 weeks for ≥120 weeks, and were assessed for cCDP (ie, time to first onset of either CDP,≥20% worsening on the timed 25-foot walk [T25FW] test or ≥20% worsening on the 9-hole peg test [9HPT]), sustained for ≥12 or≥24 weeks. Results Ocrelizumab reduced the risk of 12- and 24 week cCDP versus placebo by 26% (HR: 074; p=0.0014) and 29% (HR: 0.71; p=0.0008), respectively. Ocrelizumab also significantly reduced the risk of individual cCDP components versus placebo, including 12- and 24 week CDP and confirmed ≥20% worsening on T25FW and 9HPT. Conclusions Ocrelizumab showed consistent benefit on disability progression, ambulation and upper limb function assessed using cCDP in patients with PPMS.
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