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Multiple Sclerosis: Progress, but No Cure
Multiple sclerosis (MS) is an inflammatory disease that affects approximately 400,000 patients in the United States and 2.3 million around the world.1 The name is characterized by two key elements: multiple, referring to the numerous affected areas within the central nervous system that produce a wide array of neurological symptoms, and sclerosis, referring to the plaques or sclerosed areas commonly associated with the disease.2
No definitive cause has been identified for MS, and the clinical presentation can vary greatly from patient to patient.2,3 The clinical course is classified into one of four categories based on attributes such as symptoms, relapses, and progression:
- Relapsing–remitting MS (RRMS) is marked by frequent exacerbations; it is the most common form of MS.2,3
- Secondary-progressive MS (SPMS) is seen when RRMS patients enter a phase in which attacks and remissions are not easily identifiable.2,3
- Primary-progressive MS (PPMS) is identified by symptoms and a lack of relapses; it is most commonly diagnosed later in life.2,3
- Primary-relapsing MS (PRMS) affects the smallest group of patients and is characterized by both progression and relapses.2,3
No cure exists for MS, but multiple agents are FDA-approved to manage the condition.4 Current therapies can be divided into three groups: treatment of exacerbations, disease-modifying therapies, and symptomatic therapies.3 Traditional therapy consisted of interferon treatment, but patients did not like this option because of commonly associated adverse events and inconvenient administration.2 Newer therapies, some of them administered orally, have since been discovered with novel mechanisms of action.4
As we look to the future, the therapies most commonly under investigation would address relapsing forms of MS. Treatments are becoming more efficacious and convenient for patients. Continued therapeutic advances and identification of the causes of MS will hopefully lead to an eventual cure for this disease.4
|Status||Regimen Information||Pivotal Studies||Expected Approval||Form of MS|
|Zinbryta (daclizumab high-yield process)
|Preregistration||150 mg SC daily||DECIDE||2016||RRMS|
|Phase 3||0.6 mg PO daily||ALLEGRO, BRAVO, CONCERTO||2015||RRMS|
|Phase 3||6 mg/kg per day||NCT01433497||2016||PPMS, SPMS|
|Phase 3||600 mg IV every 24 weeks||OPERA, ORATORIO||2016 or later||RMS, PPMS|
|Phase 3||300 mg PO daily||MS-SPI||2016 or later||PPMS, SPMS|
|Phase 3||300 mg IV every 4 weeks||ASCEND||2016 or later||SPMS|
|Phase 3||20 mg PO daily||OPTIMUM||2018||RMS|
|Phase 3||0.5 mg to 1 mg PO daily||RADIANCE, SUNBEAM||2018||RMS|
|Phase 3||0.25 mg to 2 mg PO daily||EXPAND||2019 or later||SPMS|
IV = intravenously; MS = multiple sclerosis; PO = orally; PPMS = primary progressive multiple sclerosis; RMS = relapsing multiple sclerosis; RRMS = relapsing–remitting multiple sclerosis; SC = subcutaneously; SPMS = secondary progressive multiple sclerosis
Sources: FDA; GlobalData; company websites;
Selected Current Therapies
||Cost of Course of Therapy per Year|
|Glatopa (glatiramer acetate)
|2015||Relapsing forms of MS||20 mg SC every day||$78,991|
|Plegridy (peginterferon beta-1a)
|2014||Relapsing forms of MS||125 mcg SC every 14 days||$78,530|
|2014||Relapsing forms of MS||First course: 12 mg/day IV for 5 days; second course: 12 mg/day IV for 3 days, 12 months after first course||First course: $118,500; second course: $71,100|
|Tecfidera (dimethyl fumarate)
|2013||Relapsing forms of MS||240 mg PO twice a day||$79,716|
|2012||Relapsing forms of MS||7 mg or 14 mg PO daily||$79,438|
|2010||Relapsing forms of MS||0.5 mg PO daily||$85,136|
|2010||Improve walking in patients with MS||10 mg PO twice daily||$25,942|
|2004||Relapsing forms of MS; severe CD||300 mg IV every 4 weeks||$82,025|
|Rebif (interferon beta-1a)
|2002||Relapsing forms of MS||22 mcg or 44 mcg SC 3 times a week||$169,531|
|2000||MS; ANLL; advanced PC||12 mg/m2 IV every 3 months||Generic: $718|
|Avonex (interferon beta-1a)
|1996||Relapsing forms of MS||30 mcg IM once weekly||$78,530|
|Copaxone (glatiramer acetate)
|1996||Relapsing forms of MS||20 mg SC daily||$89,213|
|Betaseron (interferon beta-1b)
|1993||Relapsing forms of MS||0.25 mg SQ every other day||$54,615|
aThis list is not all-inclusive; additional therapies may be available for this disease state.
bAbbreviated indication provided; for full indication, please refer to prescribing information.
cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.
dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.
eGlatopa is the first FDA-approved, substitutable generic version of Copaxone.
f1.9 m2 used as body surface of average U.S. male.
Sources: Red Book; Drugs@FDA; and prescribing information for all medications
ANLL = acute nonlymphocytic leukemias; CD = Crohn’s disease; IM = intramuscularly; IV = intravenously; MS = multiple sclerosis; PC = prostate cancer; PO = by mouth; SC = subcutaneously
- National Multiple Sclerosis Society. MS prevalence. Available at: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed August 10, 2015
- DiPiro J, Talbert RL, Yee G, et al. Multiple sclerosis. Pharmacotherapy: A Pathophysiologic Approach
9th edNew York, New York: McGraw-Hill. 2014;835–854.
- Cleveland Clinic. Multiple sclerosis. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/neurology/multiple_sclerosis/Default.htm. Accessed August 10, 2015
- Healthline. Multiple sclerosis: what the future holds. Available at: https://www.healthline.com/health/multiple-sclerosis/what-the-future-holds. Accessed August 10, 2015