Ocrelizumab Research known by the OPERA Study

 Results of a phase 2 trial of ocrelizumab treatment in patients with relapsing-remitting multiple sclerosis (MS) show that both doses studied significantly reduced the total number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) at 24 weeks vs placebo.

Both the 600-mg and 2000-mg doses studied reduced clinical relapses, with no apparent separation between doses, and extension data in this report out to 48 weeks suggested sustained efficacy, the researchers note.

“The similarly pronounced effects of B-cell depletion with both ocrelizumab doses on MRI and relapse-related outcomes support a role for B-cells in disease pathogenesis and warrant further assessment in large, long-term trials,” the researchers, with first author Ludwig Kappos, MD, from University Hospital, Basel, Switzerland, conclude.

The results were published online November 1 in The Lancet.

The primary analysis of this study at 24 weeks was presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, in October 2010, and reported by Medscape Medical News at that time. Data to 72 weeks were presented at the 21st Meeting of the European Neurological Society, and most recently, results out to 96 weeks were presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS) in Amsterdam, the Netherlands.

The reduction in clinical relapses seen with treatment was maintained from week 24 to week 96, with subsequent infusions at 24-week intervals. In addition, patients who switched from placebo to ocrelizumab at the end of the blinded phase of the trial had similar reductions in the clinical measures of disease.

“Phase 3 has started; we are recruiting in 1 study for primary progressive [MS] and 2 studies…for relapsing forms of [MS],” David Leppert, MD, who is also from University Hospitals Basel, and F. Hoffman-La Roche Ltd, and who presented the results at ECTRIMS/ACTRIMS, told Medscape Medical News.

The phase 3 program, called ORCHESTRA, includes the 2 relapsing-remitting MS trials, called OPERA I and II, and the primary progressive MS trial, called ORATORIO.