Multiple Sclerosis
 

Existing Drug Treaments

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Product Generic Name MOA Manufacturer Indication Side Effects Dose Comments Recent Clinical trials
Avonex interferon beta-1a slows growth of white blood cells Biogen Idec RRMS (relapsing forms of M.S.) Flu-like symptoms, injection site reactions, monitoring of blood cell counts and liver function IM, 1X week, 30 mcg Convenient dosing 1.  Avonex (Interferon-Beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-Remitting MS, 2003-2008 (NCT00168766)
Betaseron 
interferon beta-1b slows growth of white blood cells Bayer/Berlex/Schering
 
RRMS (relapsing forms of M.S.) Flu-like symptoms, injection site reactions, monitoring of blood cell counts and liver function Subq, every other day, 250 mcg High dose

 
1.  Safety Study in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif, 2006-2007 (NCT00317941)   2.  RNF and Betaseron® Tolerability Study (REFORMS), 2006-2008 (NCT00428584)  3. BEYOND - Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose, 2003-? (NCT00099502) also compared to copaxone
Rebif  interferon beta-1a slows growth of white blood cells Merck Serono RRMS (relapsing forms of M.S.) Flu-like symptoms, injection site reactions, monitoring of blood cell counts and liver function Subq, 3X week, 44 mcg Most efficacious DMT against RRMS 1. REGARD - Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis, 2004-2007 (NCT00078338)  2. Rebif New Formulation (RNF) Quality of Life Study (RebiQoL), 2007-2008 (NCT00472797)   2. Combination Therapy Using Cellcept and Rebif in RRMS, 2006-2009 (NCT00618527)
Copaxone  glatiramer acetate Myelin decoy Teva/Sanofi RRMS Injection site reactions Subq, daily, 20 mg Interferon alternative, benign side effects 1.  Treatment of MS with copaxone and albuterol (NCT00039988)  2.  Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA), 2006-2009 (NCT00337779)
Novantrone  mitoxantrone Topoisomerase II inhibitor, suppresses T-cells, B-cells, an d macrophages Serono Worsening RRMS and chronic progressive MS, not for primary progressive MS Cardiac toxicity IV, 4X/year (limit of 8-12 doses), 12 mg/m2 For progressive disease, preferred add-on therapy 1.  Prospective, Open-Label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients, 2000-2008 (NCT00262314)
Tysabri


 
natalizumab Anti-α4-subunit of α4β1 and α4β7 integrins expressed on all leukocytes except neutrophils.  Selectively inhibits immune cells from leaving the bloodstream, prevents migration into chronically inflamed tissues Biogen Idec/Elan RRMS (relapsing forms of M.S.) Hypersensitivity
15 ml dose containing 300 mg should be diluted with 100 ml of diluent and infused by IV over approximately 1 hour every four weeks.  Should not be administered as an IV push or bolus injection
  
Re-introduced in mid 2006, appears to be very effective, market could double from today's level if long term safety looks good 1. IMA-06-02 Tysabri Observational Program, 2007-2012 (NCT00493298)  2.  Natalizumab Re-Initiation of Dosing, 2006-2013 (NCT00297232)   3.  Natalizumab Re-Initiation of Dosing, 2006-2008 (NCT00306592)  4.  Safety Study of Natalizumab to Treat Multiple Sclerosis, 2007-2009 (NCT00559702)  5.  TYSABRI® Global Observational Program in Safety (TYGRIS), 2007-2014 (NCT00477113)  6.  TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World, 2006-2013 (NCT00483847)

 
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