Therapeutic developments in multiple sclerosis

Bibliography

• WEINSHENKER BG, BASS B, RICE GPA et al.: The natural history of multiple sclerosis: a geographically based study I. Clinical course and disability. Brain (1989) 112:133–146.
   Google Scholar
• •This reference provides important natural history, epidemi-ological and prognostic information regarding patients with MS.
   Google Scholar
• WEINSHENKER BG, BASS B, RICE GPA et al.: The natural history of multiple sclerosis: a geographically based study: II. predictive value of the early clinical course. Brain (1989) 112:133–146.
   Google Scholar
• •See reference [1] for annotation.
   Google Scholar
• WEINSHENKER BG: The natural history of multiple sclerosis. Neurologic Clinics (1995) 13:119–146.
   PubMed Web of Science ®Google Scholar
• •See reference [1] for annotation.
   Google Scholar
• WEINSHENKER BG: The epidemiology of multiple sclerosis. Neurologic Clinics (1996) 14:291–308.
   PubMed Web of Science ®Google Scholar
• •See reference [1] for annotation.
   Google Scholar
• COMPSTON DA: McAlpine's Multiple Sclerosis, 3rd ed. Churchill Livingstone, New York, USA (1998).
   Google Scholar
• TRAPP BD, PETERSON JP, RANSOHOFF RM et al.: Axonal transection in the lesions of multiple sclerosis. N Engl. J. Med. (1998) 338:278–285.
   PubMed Web of Science ®Google Scholar
• •This reference provides good pathological information regarding the extent of axonal damage that occurs early in MS.
   Google Scholar
• HONAN WP, HERON JR, FOSTER DH et al.: Visual loss in multiple sclerosis and its relation to previous optic neuritis, disease duration and clinical classification. Brain (1990) 113:975–987.
   PubMed Web of Science ®Google Scholar
• CHIAPPA KH: Evoked Potentials in Clinical Medicine. 2nd Ed. Raven Press, New York, USA (1991).
   Google Scholar
• LUBLIN FD, REINGOLD SC: Defining the clinical course of multiple sclerosis. Neurology (1996) 46:907–911.
   PubMed Web of Science ®Google Scholar
• HAWKINS SA, MCDONNELL GV: Benign multiple sclerosis? Clinical course, long term follow up and assessment of prognostic factors. J. Neurol. Neurosurg. Psychiatr. (1999) 67:148–152.
   PubMed Web of Science ®Google Scholar
• RODRIGUEZ M, SIVA A, CROSS S et al.: Optic neuritis: a population based study in Olmsted county, Minnesota. Neurology (1994) 44:A374.
   Google Scholar
• POSER CM, PATY DW, SCHEINBERG L et al.: New diagnostic criteria for multiple sclerosis: Guidelines for Research Protocols. Ann. Neurol (1983) 13:227–231.
   PubMed Web of Science ®Google Scholar
• AMATO MP, PONZIANI G, BARTOLOZZI ML, SIRACUSA G: A prospective study on the natural history of multiple sclerosis: clues to the conduct and interpretation of clinical trials. J. Neurol. Sci. (1999) 168:96–106.
   PubMed Web of Science ®Google Scholar
• BORNSTEIN MB, MILLER A, SLAGLE S et al: A pilot trial of COP 1 in exacerbating-remitting multiple sclerosis. N Engl. J. Med. (1987) 317:408–414.
   PubMed Web of Science ®Google Scholar
• THE IFN-B MULTIPLE SCLEROSIS STUDY GROUP: Interferon beta-lb is effective in relapsing-remitting multiple sclerosis: I. Clinical results of a multi-center, randomized, double blind, placebo-controlled trial. Neurology (1993) 43:655–661.
   Google Scholar
• ••These are the results from the IFN6- lb (Betaseron) pivotaltrial in RRMS.
   Google Scholar
• PATY DW, LI DKB, THE UBC MS/MRI STUDY GROUP, THE IFN-B MULTIPLE SCLEROSIS STUDY GROUP: Interferon beta-lb is effective in remitting and relapsing multiple sclerosis: II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology (1993) 43:662–667.
   Google Scholar
• ••See reference [15] for annotation.
   Google Scholar
• THE IFN-B MULTIPLE SCLEROSIS STUDY GROUP AND THE UBC MS/MRI ANALYSIS GROUP: Interferon Beta-lb in the Treatment of MS: Final Outcome of the Random-ized Controlled Trial. Neurology (1995) 45:1277–1285.
   PubMed Web of Science ®Google Scholar
• PRISIMS STUDY GROUP: Randomized double-blind placebo-controlled study of interferon B-la in relapsing/remitting multiple sclerosis. Lancet (1998) 352:1498–1504.
   PubMed Web of Science ®Google Scholar
• ••These are the results of the IFN6-la (Rebif) pivotal trial inRRMS.
   Google Scholar
• THE ONCE WEEKLY INTERFERON FOR MS STUDY GROUP: Evidence of interferon beta-la dose response in relapsing-remitting MS: the OWIMS Study. Neurology (1999) 53:679–686.
   PubMed Web of Science ®Google Scholar
• JOHNSON KP, BROOKS BR, COHEN JA et al.: 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) 45:1268–1276.
   PubMed Web of Science ®Google Scholar
• ••These are the results of the glatiramer acetate (Copaxone)pivotal trial and the smaller MRI trial in RRMS.
   Google Scholar
• JOHNSON KP, BROOKS BR, COHEN JA et al.: Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology (1998) 50:701–708.
   PubMed Web of Science ®Google Scholar
• LI DK, PATY DW: Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta la in relapsing-remitting multiple sclerosis. Prevention of Relapses and Disability by Interferon-betala Subcuta-neously in Multiple Sclerosis. Ann. Neurol. (1999) 46:197–206.
   Google Scholar
• ••See reference [18] for annotation.
   Google Scholar
• COMI G, FILLIPPI M, THE COPAXONE MRI STUDY GROUP The effect of glatiramer acetate (Copaxone) on disease activity as measured by Cerebral MRI in patients with remitting-relapsing multiple sclerosis (RRMS): a multi-center, randomized, double-blind, placebo-controlled study extended by open label treatment. Neurology (1999) 52 (Suppl. 2):A289.
   Google Scholar
• ••See reference [20] for annotation.
   Google Scholar
• BORNSTEIN MB, MILLER A, SLAGLE S et al.: A placebo-controlled, double-blind, randomized, two-center, pilot trial of COP 1 in chronic progressive multiple sclerosis. Neurology (1991) 41:533–539.
   PubMed Web of Science ®Google Scholar
• JACOBS LD, COOKFAIR DL, RUDICK RA et al.: Intramus-cular interferon beta-la for disease progression in exacerbating-remitting multiple sclerosis. Ann. Neurol (1996) 39:285–294.
   PubMed Web of Science ®Google Scholar
• ••These are the results of the IFN6-la (Avonex) pivotal trial inRRMS.
   Google Scholar
• EUROPEAN STUDY GROUP: Placebo-controlled multicentre randomized trial of interferon 6-lb in treatment of secondary progressive multiple sclerosis. Lancet (1998) 352:1491–1497.
   PubMed Web of Science ®Google Scholar
• ••These are the results of the IFN6-lb (Betaferon) pivotal trialin SPMS.
   Google Scholar
• GONON 0, CATALAA I, BABB JS et al.: Total brainN-acetylaspartate: a new measure of disease load in MS. Neurology (2000) 54:15–19.
   Google Scholar
• INTERNATIONAL FEDERATION OF MULTIPLE SCLEROSISSOCIETIES: Symposium on a minimal record of disability in multiple sclerosis. Acta Neurol. Scand. (1984) 70\(Suppl. 100:176–181.
   Google Scholar
• AMATO MP, FRATIGLIONI L, GROPPI C et al.: Interraterreliability in assessing functional systems and disability on the Kurtzke scale in multiple sclerosis. Arch. Neurol. (1988) 45:746–748.
   PubMed Web of Science ®Google Scholar
• NOSEWORTHY JH, VANDERVORT MK, WONG CJ et al.:Canadian Cooperative MS Study Group. Interrater variability with the expanded disability status scale (EDSS) and functional systems (FS) in a multiple sclerosis clinical trial. Neurology (1990) 40:971–975.
   Google Scholar
• FRANCIS DA, BAIN P, SWAN AV, HUGHES RAC: An assess-ment of disability scales used in multiple sclerosis. Arch. Neurol. (1991) 48:299–301.
   PubMed Web of Science ®Google Scholar
• COHEN RA, KESSLER HR, FISCHER M: The expanded disability status scale (EDSS) as a predictor of impair-ments of functional activities of daily living in multiple sclerosis. J. Neurol. ScL (1993) 115:132–135.
   PubMed Web of Science ®Google Scholar
• LIU C, BLUMHARDT LD: Disability outcome measures intherapeutic trials of relpasing- remitting multiple sclerosis: effects of heterogeneity of disease course in placebo cohorts. J. Neurol Neurosurg. Psychiatr. (In Press).
   Google Scholar
• HAUSER SL, DAWSON DM, LEHRICH JR et al.: Intensive immunosupression in progressive multiple sclerosis: a randomized, three arm study of high-dose intrave-nous cyclophosphamide, plasma exchange and ACTH. N Engl. J. Med. (1983) 308:173–180.
   PubMed Web of Science ®Google Scholar
• SIPE JC, KNOBLER RL, BRAHENY SL et al.: A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology (1988) 34:1368–1372.
   Google Scholar
• GOODIN DS: A questionnaire to assess neurologicalimpairment in multiple sclerosis. Multiple Sclerosis (1998) 4:444–451.
   PubMed Web of Science ®Google Scholar
• RAO SM, LEO GJ, BERNARDIN L, UNVERZAGT F: Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns and prediction. Neurology (1991) 41:685–691.
   Google Scholar
• RAO SM, LEO GJ, ELLINGTON L, NAUERTZ T, BERNARDIN L, UNVERZAGT F: Cognitive dysfunction in multiple sclerosis II. Impact on employment and social functioning. Neurology (1991) 41:692–696.
   Google Scholar
• RUDICK RA, ANTEL J, CONFAVREUX C et al: Recommen-dations from the National Multiple Sclerosis Society clinical outcomes assessment task force. Ann. Neurol. (1997) 42:379–382.
   PubMed Web of Science ®Google Scholar
• CUTTER GR, BAIER MS, RUDICK et al.: Development of amultiple sclerosis functional composite as a clinical trial outcome measure. Brain (1999) 122:101–112.
   Google Scholar
• KAPPOS L, MOERI D, RADUE EW et al.: Predictive value ofgadolinium enhanced magnetic resonance imaging for relapse rate and changes in disability and impair-ment in multiple sclerosis: a meta-analysis. Lancet (1999) 353:964–969.
   PubMed Web of Science ®Google Scholar
• FILIPPI M, HORSFIELD MA, MORRISSEY SP etal.: Quantita-tive brain MRI lesion load predicts the course of clinically isolated syndromes suggestive of multiple sclerosis. Neurology (1994) 44:635–641.
   Google Scholar
• KHOURY SJ, GUTTMANN CRG, ORAV EJ et al.: Longitu-dinal MRI in multiple sclerosis: correlation between disability and lesion burden. Neurology (1994) 44:2120–2124.
   PubMed Web of Science ®Google Scholar
• ORIORDAN JI, THOMPSON DP, KINGSLEY DP et al.: Theprognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-year follow-up. Brain (1998) 121:495–503.
   Google Scholar
• GAWNE-CAIN ML, O'RIORDAN JI, COLES A et al.: MRIlesion volume measurement in multiple sclerosis and its correlation with disability: a comparison of fast fluid attenuated inversion recovery (FLAIR) and spin echo sequences. J. Neurol Neurosurg. Psychiatr. (1998) 64:197–203.
   Google Scholar
• MOLYNEUX PD, FILIPPI M, BARKHOF F et al.: Correla-tions between monthly enhanced MRI lesion rate and changes in T2 lesion volume in multiple sclerosis. Ann. Neurol (1998) 43:332–339.
   PubMed Web of Science ®Google Scholar
• TUBRIDY N COLES AJ, MOLYNEUX P et al.: Secondaryprogressive multiple sclerosis: the relationship between short-term MRI activity and clinical features. Brain (1998) 121:225–231.
   Google Scholar
• BARKHOF F: MRI in multiple sclerosis: Correlationwith expanded disability status scale. Multiple Sclerosis (1999) 5:283–286.
   PubMed Web of Science ®Google Scholar
• HOHLFELD R: Biotechnological agents for the immuno-therapy of multiple sclerosis. Principles, problems and perspectives. Brain (1997) 120:865–916.
   Google Scholar
• GOODIN DS, THE NORTHERN CALIFORNIA MS STUDYGROUP: Survey of multiple sclerosis in Northern California. Multiple Sclerosis (1999) 5:78–88.
   PubMed Web of Science ®Google Scholar
• CO-OPERATIVE STUDY IN THE EVALUATION OF THERAPY IN MULTIPLE SCLEROSIS: ACTH vs. placebo - final report. Neurology (1970) 20 (part 2):1–59.
   Google Scholar
• GOODIN DS: The use of immunosuppressive agents in the treatment of multiple sclerosis: a critical review. Neurology (1991) 41:980–985.
   PubMed Web of Science ®Google Scholar
• •This article provides a good discussion of some of the difficulties that can, and often do, affect the conduct and analysis of clinical trials.
   Google Scholar
• OLIVERI RL, VALENTINO P, RUSSO C et al.: Randomized trial comparing two different high doses of methyl-prednisolone in MS: a clinical and MRI study. Neurology (1998) 50:1833–1836.
   PubMed Web of Science ®Google Scholar
• BECK RW, CLEARLY PA andERSON MM et al.: A random-ized controlled trial of glucocorticoids in the treatment of acute optic neuritis. N Engl. J. Med. (1992) 326:581–588.
   PubMed Web of Science ®Google Scholar
• BECK RW, OPTIC NEURITIS STUDY GROUP: Glucocorti-coid treatment of optic neuritis: A need to change treatment practices. Neurology (1992) 42:1133–1135.
   PubMed Web of Science ®Google Scholar
• BECK RW, CLEARLY PA, TROBE JD et al.: The effect of glucocorticoids for acute optic neuritis on the subsequent development of multiple sclerosis. N Engl. J. Med. (1993) 329:1764–1769.
   PubMed Web of Science ®Google Scholar
• GOODIN DS: Perils and pitfalls in the interpretation of clinical trials: A reflection on the recent experience in multiple sclerosis. Neuroepidemiology (1999) 18:53–63.
   PubMed Web of Science ®Google Scholar
• •See reference [52] for annotation.
   Google Scholar
• KAUFMAN DI, TROBE JD, EGGENBERGER ER, WHITAKER JN: Practice parameter: The role of glucocorticoids in the management of acute monosymptomatic optic neuritis. A report of the Quality Standards Subcom-mittee of the American Academy of Neurology. Neurology (In Press).
   Google Scholar
• WEINSHENKER BG, O'BRIEN PC, PETTERSON TM et al.: A randomized trial of plasma exchange in acute central nervous system inflammatory demyelinating disease. Ann. Neurol. (1999) 46:878–886.
   Google Scholar
• THE CANADIAN CO-OPERATIVE MULTIPLE SCLEROSIS STUDY GROUP: The Canadian cooperative trial of cyclophosphamide and plasma exchange in progres-sive multiple sclerosis. Lancet (1991) 337:441–446.
   PubMed Web of Science ®Google Scholar
• GOODKIN DE: Interferon 13 therapy for multiple sclerosis. Lancet (1998) 352:1486–1487.
   PubMed Web of Science ®Google Scholar
• JOHNSON KP, PANITCH HS, HERNDON RM et al.: Interferon 13 treatment of multiple sclerosis. Lancet (1999) 353:494–498.
   PubMedGoogle Scholar
• ALAM J, GOELZ S, RIOUX P et al.: Comparative pharma-cokinetics and pharmacodynamics of two recombi-nant human interferon beta-la (IFN beta-1 a) products administered intramuscularly in healthy male and female volunteers. Pharm. Res. (1997) 14:546–549.
   PubMed Web of Science ®Google Scholar
• SALMON P, LE COTONNEE JY, GALAZKA A, ABDUHL-AHAD A, DARRAGH A: Pharmacokinetics and pharmacodynamics of recombinant human interferon-beta in healthy male volunteers./ Interferon Cytokine Res. (1996) 16:759–764.
   PubMed Web of Science ®Google Scholar
• MUNAFO A, TRINCHARD-LUGAN I, NGUYEN TXQ, BURAGLIO M: Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon beta-la after intramuscular and subcuta-neous administration. Eur. J. Neurol. (1998) 5:1–7.
   PubMedGoogle Scholar
• WITT PL, STORER BE, BRYAN GT et al: Pharmacody-namics of biological response in vivo after single and multiple doses of interferon 6. J. Immunother. (1993) 13:191–200.
   Web of Science ®Google Scholar
• MUNAFO A SPERTINE F, ROTHUIZEN L et al.: Pharmaco-dynamic response to r-hIEN beta la administered subcutaneously once-a-week (QW) or three-times-a-week (TIW), over one month. Multiple Sclerosis (1997) 3:343.
   Google Scholar
• BORNSTEIN MB, CHAMPLIN RE, COOK SD et al.: Rationale for immunomodulating therapies of multiple sclerosis. Neurology (1988) 38\(Suppl. 2):1–89.
   Google Scholar
• THE MULTIPLE SCLEROSIS STUDY GROUP: Efficacy andtoxicity of cyclosporine in chronic progressive multiple sclerosis: a randomized, double-blinded, placebo-controlled clinical trial. Ann. Neurol. (1990) 27:591–605.
   PubMed Web of Science ®Google Scholar
• GOODKIN DE, RUDICK RA, VANDERBRUG S et al.: Low-dose (7.5 mg) oral methotrexate reduces the rate of progression in chronic progressive multiple sclerosis. Ann. Neurol (1995) 37:30–40.
   Google Scholar
• SIPE JC, ROMINE JS, KOZIOL JA, MCMILLAN R, ZYROFF J, BEUTLER E: Cladribine in treatment of chronic progressive multiple sclerosis. Lancet (1994) 344:9–13.
   PubMed Web of Science ®Google Scholar
• BEUTLER E, SIPE J, ROMINE JS, KOZIOL JA, MCMILLAN R, ZYROFF J: Treatment of chronic progressive multiple sclerosis with cladribine. Proc. Nati Acad. Sci. USA (1996) 93:1716–1720.
   PubMed Web of Science ®Google Scholar
• HARTUNG HP, GONSETTE R, THE MIMS-STUDY GROUP: Mitoxantrone in progressive multiple sclerosis (MS): a placebo-controlled, randomized, observer-blind European Phase III multicenter study - clinical results. Multiple Sclerosis (1998) 4:380.
   Google Scholar
• KRAPF H, MORRISSEY SP, ZENKER 0 et al.: Mitoxantrone in progressive multiple sclerosis (MS): a placebo-controlled, randomized, observer-blind European Phase III multicenter study - MRI results. Multiple Sclerosis (1998) 4:325.
   Google Scholar
• MARTINDALE: The Extra Pharmacopoeia, 31st edition. Reynolds JEF (Ed.), Royal Pharmaceutical Society, London, UK (1996):985.
   Google Scholar
• FAZEKAS F, DEISENHAMMER F, STRASSER-FUCHS S, NAHLER, G, MAMOLI B: Randomised placebo-controlled trial of monthly intravenous immuno-globulin therapy in relapsing-remitting multiple sclerosis. Lancet (1997) 349:589–593.
   PubMed Web of Science ®Google Scholar
• SORENSEN PS, WANSCHER B, JENSEN CV et al.: Intrave-nous immunoglobulin G reduces MRI activity in relapsing multiple sclerosis. Neurology (1998) 50:1273–1281.
   PubMed Web of Science ®Google Scholar
• ACHIRON A, GABBAY U, GILAD R et al.: Intravenous immunoglobulin treatment in multiple sclerosis. Effect on relapses. Neurology (1998) 50:398–402.
   PubMed Web of Science ®Google Scholar
• GADOTH N, MELAMED E, MILLER A, STEINER I, ABRAMSKY 0: Intravenous immunoglobulin treatment in multiple sclerosis. Neurology (1999) 52:214–215.
   PubMedGoogle Scholar
• NOSEWORTHY JH, O'BRIEN P, ERICKSON BJ et al.: The Mayo Clinic-Canadian Cooperative trial of sulfasa-lazine in active multiple sclerosis. Neurology (1998) 51:1342–1352.
   Google Scholar
• LENERCEPT MS STUDY GROUP, UBC MS/MRI ANALYSISGROUP: TNF neutralization in MS: results of a random-ized, placebo-controlled multicenter study. Neurology (1999) 53:457–465.
   PubMed Web of Science ®Google Scholar