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Multiple Sclerosis: Progress, but No Cure

Kunj Gohil PharmD, RPh

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

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Form of MS
Zinbryta (daclizumab high-yield process)
Biogen/AbbVie
Preregistration 150 mg SC daily DECIDE 2016 RRMS
Laquinimod
Teva
Phase 3 0.6 mg PO daily ALLEGRO, BRAVO, CONCERTO 2015 RRMS
Masitinib
AB Science
Phase 3 6 mg/kg per day NCT01433497 2016 PPMS, SPMS
Ocrelizumab
Roche
Phase 3 600 mg IV every 24 weeks OPERA, ORATORIO 2016 or later RMS, PPMS
Biotin
MedDay
Phase 3 300 mg PO daily MS-SPI 2016 or later PPMS, SPMS
Tysabri (natalizumab)
Biogen
Phase 3 300 mg IV every 4 weeks ASCEND 2016 or later SPMS
Ponesimod
Actelion
Phase 3 20 mg PO daily OPTIMUM 2018 RMS
Ozanimod
Receptos
Phase 3 0.5 mg to 1 mg PO daily RADIANCE, SUNBEAM 2018 RMS
Siponimod
Novartis
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; ClinicalTrials.gov

Selected Current Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
Glatopa (glatiramer acetate)e
Sandoz
2015 Relapsing forms of MS 20 mg SC every day $78,991
Plegridy (peginterferon beta-1a)
Biogen
2014 Relapsing forms of MS 125 mcg SC every 14 days $78,530
Lemtrada (alemtuzumab)
Genzyme
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)
Biogen
2013 Relapsing forms of MS 240 mg PO twice a day $79,716
Aubagio (teriflunomide)
Genzyme
2012 Relapsing forms of MS 7 mg or 14 mg PO daily $79,438
Gilenya (fingolimod)
Novartis
2010 Relapsing forms of MS 0.5 mg PO daily $85,136
Ampyra (dalfampridine)
Acorda Therapeutics
2010 Improve walking in patients with MS 10 mg PO twice daily $25,942
Tysabri (natalizumab)
Biogen
2004 Relapsing forms of MS; severe CD 300 mg IV every 4 weeks $82,025
Rebif (interferon beta-1a)
EMD Serono
2002 Relapsing forms of MS 22 mcg or 44 mcg SC 3 times a week $169,531
Mitoxantrone
Multiple manufacturers
2000 MS; ANLL; advanced PC 12 mg/m2 IV every 3 months Generic: $718f
Avonex (interferon beta-1a)
Biogen
1996 Relapsing forms of MS 30 mcg IM once weekly $78,530
Copaxone (glatiramer acetate)
Teva
1996 Relapsing forms of MS 20 mg SC daily $89,213
Betaseron (interferon beta-1b)
Bayer
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

Author bio: 
Dr. Gohil is Central Services Manager with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania.

References

  1. National Multiple Sclerosis Society. MS prevalence. Available at: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed August 10, 2015
  2. DiPiro J, Talbert RL, Yee G, et al. Multiple sclerosis. Pharmacotherapy: A Pathophysiologic Approach 9th edNew York, New York: McGraw-Hill. 2014;835–854.
  3. Cleveland Clinic. Multiple sclerosis. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/neurology/multiple_sclerosis/Default.htm. Accessed August 10, 2015
  4. Healthline. Multiple sclerosis: what the future holds. Available at: https://www.healthline.com/health/multiple-sclerosis/what-the-future-holds. Accessed August 10, 2015