MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

D. H. Miller; D. Soon; K. T. Fernando; D. G. MacManus; G. J. Barker; T. A. Yousry; E. Fisher; P. W. O'Connor; J. T. Phillips; C. H. Polman; L. Kappos; M. Hutchinson; E. Havrdova; F. D. Lublin; G. Giovannoni; A. Wajgt; R. Rudick; F. Lynn; M. A. Panzara; A. W. Sandrock

doi:10.1212/01.wnl.0000260064.77700.fd

MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

D. H. Miller, D. Soon, K. T. Fernando, D. G. MacManus, G. J. Barker, T. A. Yousry, E. Fisher, P. W. O'Connor, J. T. Phillips, C. H. Polman, L. Kappos, M. Hutchinson, E. Havrdova, F. D. Lublin, G. Giovannoni, A. Wajgt, R. Rudick, F. Lynn, M. A. Panzara, A. W. Sandrock

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285 Scopus citations

Abstract

BACKGROUND: In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study. METHODS: The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years. RESULTS: Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients. CONCLUSION: Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

Original language	English
Pages (from-to)	1390-1401
Number of pages	12
Journal	Neurology
Volume	68
Issue number	17
DOIs	https://doi.org/10.1212/01.wnl.0000260064.77700.fd
State	Published - Apr 2007

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Miller, D. H., Soon, D., Fernando, K. T., MacManus, D. G., Barker, G. J., Yousry, T. A., Fisher, E., O'Connor, P. W., Phillips, J. T., Polman, C. H., Kappos, L., Hutchinson, M., Havrdova, E., Lublin, F. D., Giovannoni, G., Wajgt, A., Rudick, R., Lynn, F., Panzara, M. A., & Sandrock, A. W. (2007). MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS. Neurology, 68(17), 1390-1401. https://doi.org/10.1212/01.wnl.0000260064.77700.fd

@article{9c4edf03457143dda59144cdf68b83a8,

title = "MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS",

abstract = "BACKGROUND: In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study. METHODS: The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years. RESULTS: Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients. CONCLUSION: Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.",

author = "Miller, {D. H.} and D. Soon and Fernando, {K. T.} and MacManus, {D. G.} and Barker, {G. J.} and Yousry, {T. A.} and E. Fisher and O'Connor, {P. W.} and Phillips, {J. T.} and Polman, {C. H.} and L. Kappos and M. Hutchinson and E. Havrdova and Lublin, {F. D.} and G. Giovannoni and A. Wajgt and R. Rudick and F. Lynn and Panzara, {M. A.} and Sandrock, {A. W.}",

year = "2007",

month = apr,

doi = "10.1212/01.wnl.0000260064.77700.fd",

language = "English",

volume = "68",

pages = "1390--1401",

journal = "Neurology",

issn = "0028-3878",

publisher = "Lippincott Williams and Wilkins",

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Miller, DH, Soon, D, Fernando, KT, MacManus, DG, Barker, GJ, Yousry, TA, Fisher, E, O'Connor, PW, Phillips, JT, Polman, CH, Kappos, L, Hutchinson, M, Havrdova, E, Lublin, FD, Giovannoni, G, Wajgt, A, Rudick, R, Lynn, F, Panzara, MA & Sandrock, AW 2007, 'MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS', Neurology, vol. 68, no. 17, pp. 1390-1401. https://doi.org/10.1212/01.wnl.0000260064.77700.fd

TY - JOUR

T1 - MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

AU - Miller, D. H.

AU - Soon, D.

AU - Fernando, K. T.

AU - MacManus, D. G.

AU - Barker, G. J.

AU - Yousry, T. A.

AU - Fisher, E.

AU - O'Connor, P. W.

AU - Phillips, J. T.

AU - Polman, C. H.

AU - Kappos, L.

AU - Hutchinson, M.

AU - Havrdova, E.

AU - Lublin, F. D.

AU - Giovannoni, G.

AU - Wajgt, A.

AU - Rudick, R.

AU - Lynn, F.

AU - Panzara, M. A.

AU - Sandrock, A. W.

PY - 2007/4

Y1 - 2007/4

N2 - BACKGROUND: In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study. METHODS: The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years. RESULTS: Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients. CONCLUSION: Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

AB - BACKGROUND: In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study. METHODS: The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years. RESULTS: Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients. CONCLUSION: Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

UR - http://www.scopus.com/inward/record.url?scp=34247513840&partnerID=8YFLogxK

U2 - 10.1212/01.wnl.0000260064.77700.fd

DO - 10.1212/01.wnl.0000260064.77700.fd

M3 - Article

C2 - 17452584

AN - SCOPUS:34247513840

SN - 0028-3878

VL - 68

SP - 1390

EP - 1401

JO - Neurology

JF - Neurology

IS - 17

ER -

MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

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