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Pharmacy Services | Therapeutic Notes
Emerging therapies for multiple sclerosis
Multiple sclerosis (MS) is an immune-mediated demyelinating disease affecting the central nervous system (CNS). Nationwide, approximately 400,000 people live with MS while 2.3 million people have been diagnosed worldwide. Treatment of MS is not curative. Rather, the goal of therapy is to minimize relapses, reduce disability, and prevent new or progressive CNS lesions visible on MRI by utilizing disease-modifying therapies (DMT). Previously approved DMT include agents such as interferon, glatiramer acetate, dimethyl fumarate, and natalizumab. DMT are a mainstay of treatment of relapsing multiple sclerosis (RMS). Treatment of patients diagnosed with primary progressive multiple sclerosis (PPMS) presents a challenge as there have been no pharmacologic agents that have demonstrated a delay in further disability.
On March 28, 2017, ocrelizumab (OcrevusTM) was approved by the FDA for the treatment of PPMS and RMS. Ocrelizumab is a human- ized anti-CD20 monoclonal antibody that depletes B cells.
It is an intravenous infusion initially administered as two 300mg doses 2 weeks apart then 600mg every 6 months. In the OPERA I
& II trials, ocrelizumab was compared to interferon beta-1a (Rebif®) therapy in patients diagnosed with RMS. Superior efficacy was demonstrated by ocrelizumab in the reduction of relapses, slower progression of disability, and the reduction of MRI lesions. The ORATORIO trial evaluated ocrelizumab vs. placebo in patients affect- ed by PPMS. Ocrelizumab is the first therapy that has demonstrated slowing of disability progression and reduced MRI lesions in this population. The most common adverse reactions to ocrelizumab are infusion-related reactions during the administration of the drug and upper respiratory tract infections. Medication adherence may be
Sarah Diamond, PharmD, BCPS
improved utilizing ocrelizumab as it is only administered twice yearly (every six months) and does not require routine lab monitoring.
In July 2017, ocrelizumab was added to the Christiana Care formulary for the treatment of RMS and PPMS. In August, the Christiana Care Ambulatory Infusion Center began to treat patients in partnership with our MS clinic. Infusion clinic staff work closely with members of the MS clinic team to coordinate care and to manage any potential reactions. The majority of patients are treated at the infusion center but patients who are nonambulatory or at risk for falls may receive ocrelizumab in the ED observation unit. Having access to both locations provides the opportunity to serve more MS patients in our community.
In the battle against MS, ocrelizumab represents an exciting new era of therapy. For the first time, there is an agent that may be effective for patients with PPMS and one more drug has been added to the arsenal against RMS. In addition to demonstrating efficacy in clinical trials, the frequency in which ocrelizumab is administered may
be favorable to patients and contribute to improved adherence to therapy. At Christiana Care the MS clinic provides expert care to our patients. This specialized team allows patients to access ocrelizumab early on in their disease course with the goal of delayed progression of MS and improved quality of life. 
References
1) National Multiple Sclerosis Society. What is MS? https://www.nationalmssociety.org/ What-is-MS. Accessed December 1, 2017.
2) Ocrelizumab (OcrevusTM) Prescribing Information. Genentech, Inc; 2017.
3) Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017;376:221-234.
4) Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017;376:209-220.
CHRISTIANA CARE COMPLIANCE HOTLINE
Christiana Care’s Compliance Hotline can be used to report a violation of any regulation, law or legal requirement as it relates to billing or documentation, 24 hours a day, 7 days a week. Callers may remain anonymous. The toll-free number is: 877-REPORT-0 (877-737-6780).
To learn more about Corporate Compliance, review the Corporate Compliance Policy online or contact Christine Babenko at 302-623-4693.
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