US FDA-Approved Disease-Modifying Treatments for Multiple Sclerosis

The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis: I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 655–61 Johnson KP, Brooks BR, Cohen JA, et al., and the Copolymer 1 Multiple Sclerosis Study Group. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995; 45: 1268–76 Jacobs LD, Cookfair DL, Rudick RA, et al., and the Multiple Sclerosis Collaborative Research Group (MSCRG). Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996; 39: 285–94 PRISMS (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon β1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498–504 Härtung H-P, Gonsette R, König N, et al., and the Mitoxantrone in Multiple Sclerosis Study Group (MIMS). Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002; 360: 2018–25 Galetta SL, Markowitz C, Lee AG. Immunomodulatory agents for the treatment of relapsing multiple sclerosis. Arch Intern Med 2002; 162: 2161–9 European Study Group on Interferon β-1b in Secondary Progressive MS. Placebo-controlled multicentre randomised trial of interferon β-1b in treatment of secondary progressive multiple sclerosis. Lancet 1998; 352: 1491–7 The IFNB Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 1995; 45: 1277–85 Lublin FD, Whitaker JN, Eidelman BH, et al. Management of patients receiving interferon beta-1b for multiple sclerosis: report of a consensus congress. Neurology 1996; 46: 12–8 Jacobs LD, Beck RW, Simon JH, et al. and the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med 2000; 343: 898–904 Clanet M, Radue EW, Kappos L, et al., and the European IFNβ-1a (Avonex) Dose-Comparison Study Investigators. A randomized, double-blind, dose-comparison study of weekly interferon β-1a in relapsing MS. Neurology 2002; 59: 1507–17 Cohen JA, Cutter GR, Fischer JS, et al. Benefit of interferon β-1a on MSFC progression in secondary progressive MS. Neurology 2002; 59: 679–87 SPECTRIMS (Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS) Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 2001; 56: 1496–504 Tremlett H, Porciuncula J, Yoshida E, et al. Post-marketing surveillance: liver test abnormalities during treatment with interferon b-1a (sc), -1a (im) and -1b (sc) in clinical practice. Neurology 2003; 60Suppl. 1: A55 Francis GS, Grumser Y, Alteri E, et al. Hepatic reactions during treatment of multiple sclerosis with interferon-β-1a: incidence and clinical significance. Drug Saf 2003; 26: 815–27 Tremlete HL, Yoshida EM, Oger J. Liver injury associated with the B interferons for MS: a comparison between the three products. Neurology 2004; 62: 628–31 Yoshida EM, Rasmussen SL, Steinbrecher UP, et al. Fulminant liver failure during interferon beta treatment of multiple sclerosis. Neurology 2001; 56: 1416 Yoshida EM, Rasmussen SL, Steinbrecher UP, et al. Fulminant liver failure during interferon beta treatment of multiple sclerosis. Neurology 2001; 57: 2153 Durelli L, Bongioanni MR, Ferrero B, et al. Interferon treatment for multiple sclerosis: autoimmune complication may be lethal. Neurology 1998; 50: 570–1 Duchini A. Autoimmune hepatitis and interferon-beta 1a for multiple sclerosis. AM J Gastroenterol 2002; 97: 767–78 Panitch H, Goodin DS, Francis G, et al., for the EVIDENCE (Evidence of Interferon Dose-response: European North American Comparative Efficacy) Study Group and the University of British Columbia MS/MRI Research Group. Randomized, comparative study of interferon β-1a treatment regimens in MS: the EVIDENCE Trial. Neurology 2002; 59: 1496–506 Durelli L, Verdun E, Barbero P, et al., and the Independent Comparison of Interferon (INCOMIN) Study Group. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002; 359: 1453–60 Betaseron® [package insert]. Montville (NJ): Berlex Laboratories, 2003 Rebif® [package insert]. Randolph (MA): Serono, Inc., 2003 Avonex® [package insert]. Cambridge (MA): Biogen Inc., 2003 The PRISMS (Prevention of Relapses and Disability by Interferon-β-1a Subcutaneously in Multiple Sclerosis) Study Group, and the University of British Columbia MS/MRI Analysis Group. PRISMS-4: long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001; 56: 1628–36 Herndon RM, Jacobs LD, Coats ME, et al. Results of an ongoing, open-1abel, safety-extension study of interferon beta-1a (Avonex) treatment in multiple sclerosis. Int J MS Care 1999; 2: 1–6 Pachner AR. Anti-IFNβ antibodies in IFNβ treated MS patients. Neurology 2003; 61: S1–5 Milanese C, La Mantia L, Palumbo R, et al. A post-marketing study on interferon beta 1b and 1a treatment in relapsingremitting multiple sclerosis: different response in drop-outs and treated patients. J Neurol Neurosurg Psychiatry 2003; 74: 1689–92 Ruggieri RM, Settipani N, Viviano L, et al. Long-term interferon-beta treatment for multiple sclerosis. Neurol Sci 2003; 24: 361–4 Drago F, Brusati C, Mancardi G, et al. Localized lipoatrophy after glatiramer acetate injection in patients with remittin-grelapsing multiple sclerosis. Arch Dermatol 1999; 135:1277–8 Mancardi GL, Murialdo A, Drago F, et al. Localized lipoatrophy after prolonged treatment with copolymer 1. J Neurol 2000; 247: 220–1 Hwang L, Orengo I. Lipoatrophy associated with glatiramer acetate injections for the treatment of multiple sclerosis. Cutis 2001; 68: 287–8 Gonsette RE. Mitoxantrone immunotherapy in multiple sclerosis. Mult Scler 1996; 1: 329–32 Wiseman LR, Spencer CM. Mitoxantrone. A review of its pharmacology and clinical efficacy in the management of hormone-resistant advanced prostate cancer. Drugs Aging 1997; 10(6): 473–85 Faulds D, Balfour JA, Chrisp P, et al. Mitoxantrone: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in the chemotherapy of cancer. Drugs 1991; 41(3): 400–49 Millefiorini E, Gasperini C, Pozzilli C, et al. Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome. J Neurol 1997; 244: 153–9 Vicari AM, Ciceri F, Folli F, et al. Acute promyelocytic leukemia following mitoxantrone as single agent for the treatment of multiple sclerosis. Leukemia 1998; 12: 441–2 Brassat D, Recher C, Waubant E, et al. Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS. Neurology 2002; 59: 954–5 Ghalie RG, Mauch E, Edan G, et al. A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis. Mult Scler 2002; 8: 441–5 Cattaneo C, Almici C, Borlenghi E, et al. A case of acute promyelocytic leukaemia following mitoxantrone treatment of multiple sclerosis. Leukemia 2003; 17: 985–6 Heesen C, Bruegmann M, Gbdamosi J, et al. Therapy-related acute myelogenous leukaemia (t-AML) in a patient with multiple sclerosis treated with mitoxantrone. Mult Scler 2003; 9: 213–4 Ghalie RG, Mauch E, Edan G, et al. A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis. Mult Scler 2002; 8: 441–5 Brassat D, Recher C, Waubant E, et al. Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS. Neurology 2002; 59: 954–5 Brassat D, Recher C, Huguet FR, et al. Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS. Neurology 2003; 60: 1400 Gbadamosi J, Münchau A, Weiller C, et al. Severe heart failure in a young multiple sclerosis patient. J Neurol 2003; 250: 241–2 Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology 1999; 53: 1622–7 Frohman E, Phillips T, Kokel K, et al. Disease-modifying therapy in multiple sclerosis: strategies for optimizing management. Neurologist 2002; 8: 227–36 Bayas A, Rieckmann P. Managing the adverse effects of interferon-β therapy in multiple sclerosis. Drug Safety 2000; 22(2): 149–59 Edgar CM, Bruenet DG, Fenton P, et al. Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can J Neurol Sci. 2004; 31: 58–63 Munschauer III FE, Kinkel RP. Managing side effects of interferon-beta in patients with relapsing-remitting multiple sclerosis. Clin Ther 1997; 19(5): 883–93 Calabresi PA. Considerations in the treatment of relapsing-remitting multiple sclerosis. Neurology 2002; 58Suppl. 4: S10–22 Rio J, Nos C, Marzo ME, et al. Low-dose steroids reduce flulike symptoms at the initiation of IFNβ-1b in relapsing-remitting MS. Neurology 1998; 50: 1910–2 Novantrone® [package insert]. Seattle (WA): Immunex Corporation, 2003 Aikens JE, Fischer JS, Namey M, et al. A replicated prospective investigation of life stress, coping, and depressive symptoms in multiple sclerosis. J Behav Med 1997; 20(5): 433–45 Mohr DC, Goodkin DE, Likosky W, et al. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol 1997; 54: 531–3 Copaxone® [package insert]. Kansas City (MO): Aventis Pharmaceuticals Inc., 2003 Korczyn AD, Nisipeanu P. Safety profile of copolymer 1: analysis of cumulative experience in the United States and Israel. J Neurol 1996; 243Suppl. 1: S23–6 Avasarala JR, Cross, AH, et al. Rapid onset mitoxantrone-induced cardiotoxicity in secondary progressive multiple sclerosis. Mult Scler 2003; 9: 59–62