Interferon β-1b and glatiramer acetate effects on permanent black hole evolution

M. Filippi, M. A. Rocca, F. Camesasca, S. Cook, P. O'Connor, B. G W Arnason, L. Kappos, D. Goodin, D. Jeffery, H. P. Hartung, G. Comi, J. S. Wolinsky, T. Bogumil, C. Pohl, K. Beckmann, R. Sandbrink, E. Croze, C. Brown, T. M. Desimone, D. L. ArnoldG. Cutter, V. Knappertz

Research output: Contribution to journalArticle

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Abstract

Objective: To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNβ-1b 250 μg with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNβ-1b 500 μg and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNβ-1b 250 μg than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNβ-1b 250 μg vs GA: 21.6% vs 23.5%; p > 0.20). For IFNβ-1b 500 μg, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFNβ-1b affected PBH development to a similar or better extent than GA. IFNβ-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNβ-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

Original languageEnglish
Pages (from-to)1222-1228
Number of pages7
JournalNeurology
Volume76
Issue number14
DOIs
Publication statusPublished - Apr 5 2011

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Interferons
Glatiramer Acetate
Relapsing-Remitting Multiple Sclerosis
Phase III Clinical Trials
Gadolinium
Multiple Sclerosis
Brain

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Filippi, M., Rocca, M. A., Camesasca, F., Cook, S., O'Connor, P., Arnason, B. G. W., ... Knappertz, V. (2011). Interferon β-1b and glatiramer acetate effects on permanent black hole evolution. Neurology, 76(14), 1222-1228. https://doi.org/10.1212/WNL.0b013e3182143577

Interferon β-1b and glatiramer acetate effects on permanent black hole evolution. / Filippi, M.; Rocca, M. A.; Camesasca, F.; Cook, S.; O'Connor, P.; Arnason, B. G W; Kappos, L.; Goodin, D.; Jeffery, D.; Hartung, H. P.; Comi, G.; Wolinsky, J. S.; Bogumil, T.; Pohl, C.; Beckmann, K.; Sandbrink, R.; Croze, E.; Brown, C.; Desimone, T. M.; Arnold, D. L.; Cutter, G.; Knappertz, V.

In: Neurology, Vol. 76, No. 14, 05.04.2011, p. 1222-1228.

Research output: Contribution to journalArticle

Filippi, M, Rocca, MA, Camesasca, F, Cook, S, O'Connor, P, Arnason, BGW, Kappos, L, Goodin, D, Jeffery, D, Hartung, HP, Comi, G, Wolinsky, JS, Bogumil, T, Pohl, C, Beckmann, K, Sandbrink, R, Croze, E, Brown, C, Desimone, TM, Arnold, DL, Cutter, G & Knappertz, V 2011, 'Interferon β-1b and glatiramer acetate effects on permanent black hole evolution', Neurology, vol. 76, no. 14, pp. 1222-1228. https://doi.org/10.1212/WNL.0b013e3182143577
Filippi, M. ; Rocca, M. A. ; Camesasca, F. ; Cook, S. ; O'Connor, P. ; Arnason, B. G W ; Kappos, L. ; Goodin, D. ; Jeffery, D. ; Hartung, H. P. ; Comi, G. ; Wolinsky, J. S. ; Bogumil, T. ; Pohl, C. ; Beckmann, K. ; Sandbrink, R. ; Croze, E. ; Brown, C. ; Desimone, T. M. ; Arnold, D. L. ; Cutter, G. ; Knappertz, V. / Interferon β-1b and glatiramer acetate effects on permanent black hole evolution. In: Neurology. 2011 ; Vol. 76, No. 14. pp. 1222-1228.
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AU - Filippi, M.

AU - Rocca, M. A.

AU - Camesasca, F.

AU - Cook, S.

AU - O'Connor, P.

AU - Arnason, B. G W

AU - Kappos, L.

AU - Goodin, D.

AU - Jeffery, D.

AU - Hartung, H. P.

AU - Comi, G.

AU - Wolinsky, J. S.

AU - Bogumil, T.

AU - Pohl, C.

AU - Beckmann, K.

AU - Sandbrink, R.

AU - Croze, E.

AU - Brown, C.

AU - Desimone, T. M.

AU - Arnold, D. L.

AU - Cutter, G.

AU - Knappertz, V.

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N2 - Objective: To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNβ-1b 250 μg with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNβ-1b 500 μg and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNβ-1b 250 μg than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNβ-1b 250 μg vs GA: 21.6% vs 23.5%; p > 0.20). For IFNβ-1b 500 μg, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFNβ-1b affected PBH development to a similar or better extent than GA. IFNβ-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNβ-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

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