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Treatment with laquinimod reduces development of active MRI lesions in relapsing MS

Polman, C; Barkhof, F; Sandberg Wollheim, Magnhild LU ; Linde, A; Nordle, O and Nederman, T (2005) In Neurology 64(6). p.987-991
Abstract
Background: Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment in multiple sclerosis ( MS). The purpose of this study was to evaluate safety, tolerability, and efficacy on MRI lesions of two different doses of laquinimod compared with placebo in patients with relapsing MS. Methods: In this multicenter, double-blind, randomized trial, patients with relapsing MS received 0.1 mg or 0.3 mg laquinimod or placebo as three daily tablets for 24 weeks. Gadolinium- enhanced brain MRI scans were performed at screening, every eighth week during treatment, and 8 weeks after end of treatment. The primary efficacy variable was the cumulative number of active lesions over 24 weeks. Safety measures... (More)
Background: Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment in multiple sclerosis ( MS). The purpose of this study was to evaluate safety, tolerability, and efficacy on MRI lesions of two different doses of laquinimod compared with placebo in patients with relapsing MS. Methods: In this multicenter, double-blind, randomized trial, patients with relapsing MS received 0.1 mg or 0.3 mg laquinimod or placebo as three daily tablets for 24 weeks. Gadolinium- enhanced brain MRI scans were performed at screening, every eighth week during treatment, and 8 weeks after end of treatment. The primary efficacy variable was the cumulative number of active lesions over 24 weeks. Safety measures included adverse events, physical examination, and laboratory variables. Results: Of 256 screened patients, 209 were randomized (67 to 74 patients per group) in 20 centers. There was a significant difference between laquinimod 0.3 mg and placebo for the primary outcome measure ( mean cumulative number of active lesions reduced by 44%). In the subgroup of patients with at least one active lesion at baseline the reduction was slightly more pronounced (52%). No differences with respect to clinical variables (relapses, disability) were found. The safety profile was favorable; there were no clinical signs of undesired inflammatory manifestations. Conclusion: Oral laquinimod in a dosage of 0.3 mg daily was well tolerated and effective in suppressing development of active lesions in relapsing multiple sclerosis. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Neurology
volume
64
issue
6
pages
987 - 991
publisher
American Academy of Neurology
external identifiers
  • wos:000227806600011
  • pmid:15781813
  • scopus:15244353263
ISSN
1526-632X
language
English
LU publication?
yes
id
d41a5d4f-062b-4403-a9cf-25faeda2bf61 (old id 247901)
alternative location
http://www.neurology.org/cgi/content/abstract/64/6/987
date added to LUP
2007-10-05 12:24:51
date last changed
2017-08-27 05:14:39
@article{d41a5d4f-062b-4403-a9cf-25faeda2bf61,
  abstract     = {Background: Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment in multiple sclerosis ( MS). The purpose of this study was to evaluate safety, tolerability, and efficacy on MRI lesions of two different doses of laquinimod compared with placebo in patients with relapsing MS. Methods: In this multicenter, double-blind, randomized trial, patients with relapsing MS received 0.1 mg or 0.3 mg laquinimod or placebo as three daily tablets for 24 weeks. Gadolinium- enhanced brain MRI scans were performed at screening, every eighth week during treatment, and 8 weeks after end of treatment. The primary efficacy variable was the cumulative number of active lesions over 24 weeks. Safety measures included adverse events, physical examination, and laboratory variables. Results: Of 256 screened patients, 209 were randomized (67 to 74 patients per group) in 20 centers. There was a significant difference between laquinimod 0.3 mg and placebo for the primary outcome measure ( mean cumulative number of active lesions reduced by 44%). In the subgroup of patients with at least one active lesion at baseline the reduction was slightly more pronounced (52%). No differences with respect to clinical variables (relapses, disability) were found. The safety profile was favorable; there were no clinical signs of undesired inflammatory manifestations. Conclusion: Oral laquinimod in a dosage of 0.3 mg daily was well tolerated and effective in suppressing development of active lesions in relapsing multiple sclerosis.},
  author       = {Polman, C and Barkhof, F and Sandberg Wollheim, Magnhild and Linde, A and Nordle, O and Nederman, T},
  issn         = {1526-632X},
  language     = {eng},
  number       = {6},
  pages        = {987--991},
  publisher    = {American Academy of Neurology},
  series       = {Neurology},
  title        = {Treatment with laquinimod reduces development of active MRI lesions in relapsing MS},
  volume       = {64},
  year         = {2005},
}