Laquinimod Beneficial in Reducing Multiple Sclerosis Relapse Rate in Clinical Trials
Multiple sclerosis is an autoimmune disease characterized by symptomatic episodes that alternate with periods of remission. The amount of disability and discomfort a patient experiences depends partly on how often relapses occur. An experimental drug developed by Teva Pharmaceutical Industries has been found in clinical studies to reduce MS relapse rate by 23% over a placebo, bringing hope to many patients.
Laquinimod Reduced Relapse Rate and Disability Progression
Laquinimod is an oral immunomodulator that alters T-cell activity systemically and within the brain. These agents prevent autoreactive T-cells from leaving the lymphatic system, thereby helping to protect nerve fibers from the attack that underlies multiple sclerosis.
The ALLEGRO trial enrolled just over 1106 patients from 139 sites in 24 countries with relapsing-remitting MS. Patients were randomized to receive either a once-daily dose of 0.6 mg of laquinimod or placebo for 24 months. The primary endpoint was annualized relapse rate and secondary endpoints included the cumulative number of gadolinium-enhancing and new or newly enlarging T2 lesions. The patients were also measured on the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite.
In addition to a reduction in relapse rate, laquinimod was also associated with a 36% reduction in disability progression compared with placebo. Progression of brain atrophy was reduced by 32.6%. Laquinimod also did not appear to suppress the immune system, so there was no increased risk of infection that is associated with other MS drugs.
"In this trial, what I think was surprising was that the effect on disability is larger than the effect on relapses," said Dr. Giancarlo Comi, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan. Severe relapses leading to hospitalization were reduced by 38%, he noted. "So you have to ask yourself, what is better at the end of 2 years — to have a better physical condition or an attack less?"
The study authors note that 79% of the treated patients and 77% of the placebo patients completed follow up. The main reasons for discontinuation of the study were adverse events that included headache, abdominal pain, and back pain and transient elevations of liver enzymes.
The results from this study will be presented during the Clinical Trials Session at the American Academy of Neurology 63rd Annual Meeting in Honolulu.
Teva says that the company expects results from another late stage laquinimod study entitled BRAVO by the middle of the third quarter and that with FDA approval late this year or early next year, the drug could be on the market in late 2012 or early 2013.
American Academy of Neurology (AAN) 63rd Annual Meeting: Abstract P05.288. Presented April 12, 2011.