Ocrelizumab Approval to Shift Multiple Sclerosis Treatment Landscape

Patients, advocates, and researchers alike are celebrating after the FDA approval of the long-awaited multiple sclerosis (MS) drug ocrelizumab (Ocrevus, La Roche). To date, ocrelizumab is the first and only treatment approved for patients with primary progressive MS.
Ocrelizumab is a humanized monoclonal antibody designed to target CD20-positive B cells for the treatment of both relapsing and primary progressive MS. Review of the Biologics License Application of ocrelizumab took place today, after being delayed by the FDA in December 2016.
Dr Michael Racke, professor of neurology and neuroscience at Ohio State University Wexner Medical Center, known for his research in immunology and MS, spoke with Specialty Pharmacy Times regarding the importance of ocrelizumab and how it will change the MS landscape.

SPT: What role did the Ohio State University Wexner Medical Center play in the upcoming approval for ocrelizumab?
Dr Racke: We were a site for both OPERA and ORATORIO, clinical trials analyzing ocrelizumab. For OPERA, there were 2 trials: OPERA 1 and OPERA 2, which looked at ocrelizumab as compared to interferon beta-1a, so it was a head-to-head trial, which was a little bit different. A lot of times MS medications first are against placebo, but this one was against a very good MS medication and ocrelizumab did very well. There are no approved drugs for primary progressive MS, and ORATORIO was the first trial to show a benefit in primary progressive MS. So that’s the reason the FDA gave it breakthrough drug status, and we were also a site there.
I think from the Ohio State prospective, we’ve been very much involved in kind of the forerunner of ocrelizumab with a drug called rituximab. We did a clinical trial with rituximab in primary progressive MS, and it did not work. But when we analyzed the data, the patients were under the age of 51 or who had active disease and appeared the drug was beneficial for those patients. Genentech was involved in that initial study, and when the ocrelizumab study came out, they went with a younger patient population. The average age of the patients in ORATORIO was 5 years younger than our national rituximab study but beneficial. If you look at it as a whole––at both the OPERA studies and the ORATORIO study––the major effect of this monoclonal antibody really is that it reduces inflammation dramatically in MS.
SPT: How will ocrelizumab change the treatment landscape for patients with MS, particularly these forms of the disease?
Dr Racke: It has a big effect on relapsing patients. If you look at what’s available in the monoclonal antibodies in terms of safety, I would say that the safety profile––at least so far––looks much better than natalizumab and alemtuzumab. Natalizumab was the drug that after it had its initial FDA approval was pulled off the market for a while because of cases of progressive multifocal leukoencephalopathy. There continues to be a trickle of patients who are diagnosed with that disorder, [but] there are no cases reported of ocrelizumab having that effect.
Alemtuzumab also has a very high efficacy profile but it also has baggage. Within 5 years, approximately 50% of patients get another autoimmune disease despite [alemtuzumab] working pretty well to treat their MS. I think that from the patient’s perspective the opportunity to get a highly-efficacious monoclonal antibody that just has a lot less [issues] of the other monoclonal antibodies, that’s going to make a big difference for the patients.

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