Investigational Drug Effective in 2 Types of Multiple Sclerosis

Ocrelizumab reduced disease activity in patients with relapsing multiple sclerosis and primary progressive multiple sclerosis.

Researchers recently discovered that ocrelizumab (Ocrevus) may effectively treat patients with multiple sclerosis (MS), according to a study published in the New England Journal of Medicine.

The positive results were seen in three phase 3 clinical trials of the drug in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

RMS is the most common form of the disease, and is characterized by relapses followed by periods of recovery. PPMS is characterized by steady disease progression without relapses or periods of recovery. While there are numerous drugs that can control the symptoms of RMS, there are no treatments for the condition.

Since the immune system of patients with MS attacks the body, all treatment options target T cells. However, ocrelizumab targets the immune system’s B cells.

The OPERA I and OPERA II trials included patients with RMS, and the ORATORIO study included patients with PPMS. All 3 studies were sponsored by Roche, who is the owner of ocrelizumab.

In the OPERA trials, treatment with ocrelizumab was compared with interferon beta-1a (Rebif) in terms of safety and efficacy.

The investigators discovered that inflammatory lesions in patients treated with ocrelizumab were reduced by 95%, compared with patients treated with interferon beta-1a, according to the study. Patients taking ocrelizumab were observed to have a 99% reduction in lesions compared with baseline.

The researchers said that the reduction in lesions in these trials was groundbreaking.

Patients in the ocrelizumab group also had a 47% reduction in relapse, and 43% reduction in disability, compared with the interferon group, according to the study.

Since there are no treatments for PPMS, ocrelizumab was tested against placebo in the ORATORIO trials. In some patients, reductions in disability progression was achieved, while other patients experienced disease worsening.

In all trials of ocrelizumab, common adverse events included infusion-related reactions and infections.

“This work, which we hope will have great benefits for the millions of people with MS, is the result of a longstanding collaboration between the global scientific community and industry,” said corresponding author Stephen Hauser, MD.

Currently, ocrelizumab is under review by the FDA and the European Medicines Agency, and was previously granted priority review designation. If approved, ocrelizumab would offer an effective treatment option to patients with RMS and PPMS, where there are few to no drugs available.

“These new publications indicate that B cells play a central role in MS,” Dr Hauser said. “In the OPERA I and OPERA II RMS studies, ocrelizumab consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile. The consistency of these data, the effect seen in these clinical studies, and the favorable safety profile may support treating MS earlier with a high-efficacy, disease-modifying medicine.”