New Dose of Glatiramer Acetate May Have Advantages, Compared With Standard Dose
The participants’ average EDSS was approximately 2.8, and disease onset had occurred approximately seven and a half years previously, on average. The volume of T2 lesion load ranged from 17 cm3 to 20 cm3, which was “remarkably high” for patients with relapsing-remitting MS, said Dr. Khan. In most relapsing-remitting trials, T2 lesion load ranges between 7 cm3 and 9 cm3, he added.
Early Treatment Was Associated With Improved Outcomes
At the end of the placebo-controlled study, the new formulation of glatiramer acetate was associated with a 34% reduction in confirmed relapses, compared with placebo. At 12 months of the open-label extension, participants who had never been exposed to placebo had 31% fewer confirmed relapses, compared with patients in the delayed-start arm. The results emphasize “that starting treatment early makes a difference,” said Dr. Khan.
Many of the adverse events recorded during the extension were related to the local injection site. They included injection-site erythema, pain, pruritus, and swelling. Approximately 1% of patients had injection-site atrophy, which tends to appear in the second and third year of treatment with glatiramer acetate. Eight participants became pregnant during the study. Four had elective abortions, and four discontinued the study and gave birth to normal newborns.
The new formulation of glatiramer acetate appears to have a favorable safety profile that is similar to that of the conventional 20-mg formulation. The study is ongoing, and patients will have been followed up for 36 months, including the 12-month placebo-controlled phase, by the time of completion.
—Erik Greb
