Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis
| dc.contributor | ALLEGRO Study Group | |
| dc.contributor.author | Comi, Giancarlo | |
| dc.contributor.author | Jeffery, Douglas | |
| dc.contributor.author | Kappos, Ludwig | |
| dc.contributor.author | Montalban, Xavier | |
| dc.contributor.author | Boyko, Alexey | |
| dc.contributor.author | Rocca, Maria A. | |
| dc.contributor.author | Filippi, Massimo | |
| dc.contributor.author | Brieva Ruiz, Luis | |
| dc.date.accessioned | 2019-01-31T10:07:00Z | |
| dc.date.available | 2019-01-31T10:07:00Z | |
| dc.date.issued | 2012 | |
| dc.description.abstract | BACKGROUND Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing–remitting multiple sclerosis. METHODS We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 patients with relapsing–remitting multiple sclerosis were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted magnetic resonance imaging. RESULTS Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (±SE) annualized relapse rate (0.30±0.02 vs. 0.39±0.03, P = 0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P = 0.01). The mean cumulative numbers of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted images were lower for patients receiving laquinimod than for those receiving placebo (1.33±0.14 vs. 2.12±0.22 and 5.03±0.08 vs. 7.14±0.07, respectively; P<0.001 for both comparisons). Transient elevations in alanine aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 patients receiving laquinimod (5%) and 8 receiving placebo (2%). CONCLUSIONS In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing–remitting multiple sclerosis. | ca_ES |
| dc.description.sponsorship | Funded by Teva Pharmaceutical Industries; ClinicalTrials.gov number, NCT00509145. | ca_ES |
| dc.identifier.doi | https://doi.org/10.1056/NEJMoa1104318 | |
| dc.identifier.idgrec | 024987 | |
| dc.identifier.issn | 0028-4793 | |
| dc.identifier.uri | http://hdl.handle.net/10459.1/65687 | |
| dc.language.iso | eng | ca_ES |
| dc.publisher | Massachusetts Medical Society | ca_ES |
| dc.relation.isformatof | Reproducció del document publicat a https://doi.org/10.1056/NEJMoa1104318 | ca_ES |
| dc.relation.ispartof | The New England Journal of Medicine, 2012, vol. 366, núm. 11, p. 1000-1009 | ca_ES |
| dc.rights | (c) Massachusetts Medical Society | ca_ES |
| dc.rights.accessRights | info:eu-repo/semantics/openAccess | ca_ES |
| dc.title | Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis | ca_ES |
| dc.type | info:eu-repo/semantics/article | ca_ES |
| dc.type.version | info:eu-repo/semantics/publishedVersion | ca_ES |