PO127 Composite confirmed disability progression in oratorio. (1st December 2017)

• Record Type: Journal Article
• Authors: Giovannoni, Gavin; Arnold, Douglas L; Bar-Or, Amit; Seze, Jérôme de; Hemmer, Bernhard; Montalban, Xavier; Belachew, Shibeshih; Bernasconi, Corrado; Garren, Hideki; Wolinsky, Jerry
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 88(2017)Supplement 1
• Page Start: A45
• Page End: A46
• Publication Date: 2017-12-01
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2017-ABN.157
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : 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.