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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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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Neurology
volume
67
issue
6
pages
944 - 953
publisher
Lippincott Williams & Wilkins
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
date last changed
2022-02-12 08:54:27
@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    = {{Lippincott Williams & Wilkins}},
  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}},
}