Baseline Demographics and Disease Characteristics from ORATORIO, a Phase III Trial Evaluating Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis (P7.017)
2015; Lippincott Williams & Wilkins; Volume: 84; Issue: 14_supplement Linguagem: Inglês
10.1212/wnl.84.14_supplement.p7.017
ISSN1526-632X
AutoresXavier Montalbán, Bernhard Hemmer, Kottil Rammohan, Gavin Giovannoni, de Sèze, Amit Bar‐Or, Douglas L. Arnold, Annette Sauter, David Leppert, Peter Chin, Hideki Garren, Jerry S. Wolinsky,
Tópico(s)Multiple Sclerosis Research Studies
ResumoOBJECTIVE: To present demographic and baseline disease characteristics of patients in the ORATORIO study. BACKGROUND: Growing evidence indicates that B cells occupy a prominent role in the pathophysiology of MS including primary progressive MS (PPMS). Given this evidence and existing unmet medical needs, ocrelizumab (OCR), a recombinant humanized monoclonal antibody designed to selectively target CD20+ B cells, is being investigated in a phase III study in PPMS. DESIGN/METHODS: ORATORIO is a randomized (ratio of 2:1, active:placebo) parallel-group, double-blinded, placebo-controlled study examining the efficacy and safety of 600 mg OCR or placebo, every 24 weeks until the last patient has reached at least 120 weeks. Entry criteria included a diagnosis of PPMS (McDonald criteria, 2005), documented evidence of elevated IgG index or presence of CSF oligoclonal bands, age of 18-55 years, and Expanded Disability Status Scale (EDSS) score of 3.0 to 6.5 at screening. The primary outcome measure is the time to onset of confirmed disability progression, defined as an increase in EDSS score that is sustained for at least 12 weeks. RESULTS: A total of 732 patients were randomized by 183 sites in 29 countries. Baseline mean age was 44.6; 49.3[percnt] of patients were female and 94.1[percnt] were Caucasian. Mean duration of MS symptoms was 6.48 years (range 0.9-32.9 years), and the mean EDSS score was 4.74. The mean number of gadolinium enhancing (Gd+) lesions on brain MRI was 1.00, with 73.6[percnt] of patients with no Gd+ lesions. The mean normalized brain volume was 1465.0 cm3. CONCLUSIONS: The ORATORIO baseline data are consistent with a PPMS population. The results of the ORATORIO study will provide information on the efficacy and safety of ocrelizumab in PPMS. Study Supported by: F.Hoffmann La-Roche
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