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Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS

Kappos, L. ; Traboulsee, A. ; Constantinescu, C. ; Eraelinna, J.-P. ; Forrestal, F. ; Jongen, P. ; Pollard, J. ; Sandberg Wollheim, Magnhild LU ; Sindic, C. and Stubinski, B. , et al. (2006) In Neurology 67(6). p.944-953
Abstract
Objective: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis ( PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (SC) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: The original cohort of 560 patients was randomized to IFN beta-1a, 44 or 22 mu g three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline. Results: LTFU was attended by 68.2% of the original PRISMS study cohort ( 382/560... (More)
Objective: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis ( PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (SC) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: The original cohort of 560 patients was randomized to IFN beta-1a, 44 or 22 mu g three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline. Results: LTFU was attended by 68.2% of the original PRISMS study cohort ( 382/560 patients). 72.0% (275/382) were still receiving IFN beta-1a SC TIW. Patients originally randomized to IFN beta-1a 44 mu g SC TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group. Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated. Conclusions: Despite the limitations inherent in any long-term study ( for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose. (Less)
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Contribution to journal
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Neurology
volume
67
issue
6
pages
944 - 953
publisher
American Academy of Neurology
external identifiers
  • wos:000240749900006
  • pmid:17000959
  • scopus:33749027200
ISSN
1526-632X
language
English
LU publication?
yes
id
1c999871-47d8-46bd-8281-ec6e21309d1f (old id 392616)
alternative location
http://www.neurology.org/cgi/content/abstract/67/6/944
date added to LUP
2016-04-01 15:37:44
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2020-01-12 18:37:26
@article{1c999871-47d8-46bd-8281-ec6e21309d1f,
  abstract     = {Objective: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis ( PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (SC) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: The original cohort of 560 patients was randomized to IFN beta-1a, 44 or 22 mu g three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline. Results: LTFU was attended by 68.2% of the original PRISMS study cohort ( 382/560 patients). 72.0% (275/382) were still receiving IFN beta-1a SC TIW. Patients originally randomized to IFN beta-1a 44 mu g SC TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group. Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated. Conclusions: Despite the limitations inherent in any long-term study ( for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose.},
  author       = {Kappos, L. and Traboulsee, A. and Constantinescu, C. and Eraelinna, J.-P. and Forrestal, F. and Jongen, P. and Pollard, J. and Sandberg Wollheim, Magnhild and Sindic, C. and Stubinski, B. and Uitdehaag, B. and Li, D.},
  issn         = {1526-632X},
  language     = {eng},
  number       = {6},
  pages        = {944--953},
  publisher    = {American Academy of Neurology},
  series       = {Neurology},
  title        = {Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS},
  url          = {http://www.neurology.org/cgi/content/abstract/67/6/944},
  volume       = {67},
  year         = {2006},
}