Abstract: Baseline Demographics and Disease Characteristics from Opera Phase III Trials Evaluating Ocrelizumab in Patients with Relapsing Multiple Sclerosis (2015 CMSC Annual Meeting)

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Baseline Demographics and Disease Characteristics from Opera Phase III Trials Evaluating Ocrelizumab in Patients with Relapsing Multiple Sclerosis

Friday, May 29, 2015

Griffin Hall

Stephen L Hauser, MD , University of California San Francisco, San Francisco, CA

Giancarlo Comi, MD , University Vita-Salute San Raffaele, Milan, Italy

Hans-Peter Hartung, MD, FRCP, FAAN, FANA , Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

Fred Lublin, MD , Icahn School of Medicine at Mount Sinai, New York, NY

Krzysztof W Selmaj, MD, PhD , Department of Neurology, Medical Academy of Lodz, Lodz, Poland

Anthony Traboulsee, MD , University of British Columbia, Vancouver, BC, Canada

Amit Bar-Or, MD, FRCPC , Montreal Neurological Institute and Hospital, McGill University, Montreal, QC, Canada

Douglas L Arnold, MD , McGill University, Montreal, QC, Canada

Gaelle Klingelschmitt, MSc , Global Medical Affairs, Neuroscience, F. Hoffmann La-Roche Ltd., Basel, Switzerland

David Leppert, MD , Global Medical Affairs, Neuroscience, F.Hoffmann La-Roche / Genentech, Basel, Switzerland

Algirdas Kakarieka, PhD , Global Medical Affairs, Neuroscience, F.Hoffmann La-Roche / Genentech, Basel, Switzerland

Hideki Garren, MD, PhD , Global Medial Affairs, Neuroscience, F. Hoffmann-La Roche Ltd., Basel, Switzerland

Ludwig Kappos, MD, PhD , University Hospital Basel, Basel, Switzerland

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Background:

Ocrelizumab (OCR) is a recombinant humanized monoclonal antibody that selectively targets CD20+ B-cells. Two Phase III trials, OPERA I and II, are investigating the efficacy and safety of OCR compared with INFβ in patients with relapsing MS (RMS).

Objectives:

To present demographic and baseline disease characteristics of patients in the OPERA I and II studies.

Methods:

The OPERA trials are randomized, double-blinded, double-dummy, parallel-group studies investigating the efficacy and safety of 600 mg OCR administered by intravenous infusion every 24 weeks compared with high-dose, high-frequency IFNβ1a (44 µg 3x per week). Patients were randomized (1:1) to OCR or IFNβ. Entry criteria included a diagnosis of RMS (McDonald criteria, 2010), Expanded Disability Status Scale (EDSS) score of 0-5.5, and age of 18-55 years. At least 2 documented relapses within the last 2 years or one relapse in the last one year prior to screening were required. The primary endpoint is the annualized relapse rate at 2 years.

Results:

A total of 821 and 835 patients were randomized in OPERA I and II, respectively. Mean baseline age was 37.0 and 37.3 years, respectively in OPERA I and II; 66.0% of patients were female. Patients had symptoms of MS for a mean duration of 6.5 years in OPERA I and 6.7 years in OPERA II. The mean EDSS score was 2.80 in OPERA I and 2.82 in OPERA II. The mean number of gadolinium enhancing (Gd+) lesions on brain MRI was 1.79, with 59.7% of patients with no Gd+ lesions in OPERA I, and 1.87 and 59.8% respectively in OPERA II.

Conclusions:

The OPERA I and II baseline data are consistent with a RMS population. The results of the OPERA studies will provide information on the efficacy and safety of ocrelizumab compared with IFNβ in RMS.

DX32 Baseline Demographics and Disease Characteristics from Opera Phase III Trials Evaluating Ocrelizumab in Patients with Relapsing Multiple Sclerosis

DX32
Baseline Demographics and Disease Characteristics from Opera Phase III Trials Evaluating Ocrelizumab in Patients with Relapsing Multiple Sclerosis