Preliminary Results of the OPERA I and OPERA II Open-Label Extension Study

Friday, May 26, 2017: 3:42 PM
R06 (New Orleans Convention Center)
Robert T Naismith, MD , Washington University School of Medicine, St. Louis, MO
Mark Cascione, MD , Axiom Clinical Research of Florida, Tampa, FL
Luigi ME Grimaldi, MD , Fondazione Istituto - G. Giglio, Cefalu, PA, Italy
Stephen L Hauser, MD , University of California, San Francisco, San Francisco, CA
Ludwig Kappos, MD , University Hospital Basel, University of Basel, Basel, Switzerland
Xavier Montalban, MD, PhD , Vall d'Hebron University Hospital, Barcelona, Spain
Jerry S Wolinsky, MD , McGovern Medical School, UTHealth, Houston, TX
Peter Chin, MD , Genentech Inc., South San Francisco, CA
Hideki Garren, PhD, MD , Genentech Inc., South San Francisco, CA
Laura Julian, PhD , Genentech, Inc., South San Francisco, CA
Fabian Model, PhD , F. Hoffmann-La Roche Ltd, Basel, Switzerland
David Honeycutt, MD , Neurology Associates P.A., Multiple Sclerosis Center of Greater Orlando, Maitland, FL
Robert T Naismith, MD , Washington University School of Medicine, St. Louis, MO

Background: The efficacy and safety of ocrelizumab in relapsing multiple sclerosis (RMS) has been demonstrated in 2 identical phase III trials (OPERA I and OPERA II). Upon completion of the 96-week controlled treatment period in both trials, all patients were eligible to enter an ocrelizumab open-label extension (OLE) phase.

Objectives: To preliminarily assess annualized relapse rate (ARR) at 144 weeks among patients with RMS who received ocrelizumab or interferon beta-1a (IFN β-1a) in the OPERA I and II trials, followed by ocrelizumab in an OLE.

Methods: During the controlled treatment period, patients received intravenous ocrelizumab 600 mg every 24 weeks or subcutaneous IFN β-1a 44 μg three times weekly for 96 weeks. During the OLE, patients from the IFN β-1a group were switched to ocrelizumab.

Results: Patients from OPERA I (ocrelizumab, 352/410; IFN β-1a, 326/411) and OPERA II (ocrelizumab, 350/417; IFN β-1a, 297/418) were enrolled in the OLE. At the time of analysis, 317 and 322 patients on continuous ocrelizumab and 307 and 268 patients switching from IFN β-1a in OPERA I and II, respectively, had ≥48 weeks of follow-up in the OLE (144 weeks total). Across groups, patients received a median of two doses of ocrelizumab in the OLE. Among patients switching from IFN β-1a to ocrelizumab, the unadjusted ARR improved from 0.245 and 0.254 over the 96-week double-blind controlled treatment period in OPERA I and II, respectively, to 0.092 and 0.115 in the OLE. Among patients on continuous ocrelizumab, the unadjusted ARR was 0.136 and 0.138 during the double-blind controlled treatment period of OPERA I and II, respectively; during the OLE, the ARR in this group was 0.118 and 0.100, respectively. Imaging metrics will be presented.

Conclusions: Patients who originally received ocrelizumab in the OPERA studies continued to have favorable ARR outcomes in the OLE. Patients who switched from IFN β-1a to ocrelizumab in the OLE rapidly experienced ARR outcomes consistent with those of patients who received continuous ocrelizumab.