Study results show that oral laquinimod reduces the annual relapse rate in patients with relapsing-remitting multiple sclerosis.
The new oral drug laquinimod reduces the annual relapse rate in patients with relapsing-remitting multiple sclerosis, according to a study presented at the 63rd Annual Meeting of the American Academy of Neurology.
Laquinimod reduced the annual relapse rate by 23% compared to placebo (p=0.0024), and experienced other clinical and neuroimaging benefits in this two-year study.
“The study results are exciting, as they suggest that oral laquinimod is a novel therapeutic option that safely slows MS disease activity and progression,” said lead investigator Giancarlo Comi, MD, Director of the Department of Neurology at the University Vite Salute in San Raffaele, Italy.
The trial was conducted at 139 sites in 24 countries. It enrolled 1106 patients, who were randomized to placebo or 0.6 mg laquinimod once daily for 24 months.
The primary endpoint was the annualized relapse rate. Secondary endpoints included cumulative number of gadolinium enhancing lesions and new or newly enlarging T2 lesions, as well as clinical scales of disability and function.
In addition to the reduction in the relapse rate, laquinimod treatment was associated with a 36% reduction in disability progression as measured on the Expanded Disability Status Scale, (p=0.0122).
The mean cumulative number of gadolinium-enhancing and new T2 lesions were both significantly lower in patients receiving laquinimod (p=0.0003 and p=0.0002, respectively). Laquinimod-treated patients also had a 33% slowing of brain atrophy (p<0.0001) by the study's end.
Among adverse events, only transient elevation of liver enzymes was more common in the laquinimod-treated group. The elevation was not accompanied by other signs of liver dysfunction, and was reversible, Comi said. No signs of general immune suppression were observed.
The drug appears to reduce demyelination and axonal damage, “the main determinant of permanent clinical disability in MS,” he said, based on other data presented at the meeting. “this trial demonstrated that laquinimod is an efficacious, safe and well-tolerated disease-modifying oral immunomodulator with a clear effect on the accumulation of irreversible nervous tissue damage.”
The study was supported by Teva Pharmaceuticals.