论文部分内容阅读
Background: Laquinimod is a novel immunomodulatory substance developed as an o rally available disease modifying treatment in multiple sclerosis (MS). The purp ose of this study was to evaluate safety, tolerability, and efficacy on MRI lesi ons of two different doses of laquinimod compared with placebo in patients with relapsing MS. Methods: In this multicenter, double-blind, randomized trial, pat ients 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 trea tment. The primary efficacy variable was the cumulative number of active lesions over 24 weeks. Safety measures included adverse events, physical examination, a nd laboratory variables. Results: Of 256 screened patients, 209 were randomized (67 to 74 patients per group) in 20 centers.There was a significant difference b etween laquinimod 0.3 mg and placebo for the primary outcome measure (mean cumul ative number of active lesions reduced by 44%). In the subgroup of patients wit h at least one active lesion at baseline the reduction was slightly more pronoun ced (52%). No differences with respect to clinical variables (relapses, disabil ity) were found.The safety profile was favorable; there were no clinical signs o f 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.
Background: Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment in multiple sclerosis (MS). The purp ose of this study was to evaluate safety, tolerability, and efficacy on MRI lesi ons of two different doses of laquinimod with placebo in patients with relapsing MS. Methods: In this multicenter, double-blind, randomized trial, pat ients 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 The primary efficacy variable was the cumulative number of active lesions over 24 weeks. Results: At screening, every eighth week during treatment, and 8 weeks after end of trea tment. Of 256 screened patients, 209 were randomized (67 to 74 patients per group) in 20 centers. There was a significant difference b etween laquinimod 0.3 mg and placebo for the primary outcome measure (mean cumul ative number of active lesions reduced by 44%). In the subgroup of patients wit h at least one active lesion at baseline the reduction was slightly more pronoun ced (52%). No differences with respect to Clinical variables (relapses, disabil ity) 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.