Biogen Idec revealed data from its second year of the phase 3 ADVANCE clinical trial for the study of Plegridy as a treatment for patients with relapsing forms of multiple sclerosis, which demonstrated the positive effects of the subcutaneous injectable therapy beyond the first year of the study. The findings were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) in Boston last week.
The two-year results of the phase 3 ADVANCE clinical trial demonstrated Plegridy’s positive results in reducing disease activity and disability progression for the period of the study. Biogen’s researchers assessed its effectiveness by measuring evidence of disease activity (NEDA), defined as the absence of clinical and MRI disease activity over two years of treatment.
The study concluded that more patients who were administrated with Plegridy for two years achieved NEDA, than the ones who switched to Plegridy from placebo. Significant reductions in the risk of 24-week confirmed disability progression in patients treated with Plegridy during the two years was also noted in comparison to patients treated with placebo during the first year.
“These new, two-year data from ADVANCE further support the compelling efficacy and safety of Plegridy, providing physicians and patients with additional confidence in the benefits of using Plegridy to treat this chronic disease,” said the vice president of Multiple Sclerosis Research and Development at Biogen Idec, Gilmore O’Neill.
The patients who participated in the ADVANCE study revealed statistically significant improvements in clinical and MRI outcomes, as measured by annualized relapse rate (ARR), risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions compared to the group of patients who switched to Plegridy after taking placebo for the first year. The safety profile of Plegridy was consistent in both years of the study.
“The ADVANCE data suggest that treatment with Plegridy offers benefits in reductions in relapses, confirmed disability progression and brain lesions over the course of two years,” explained Douglas Arnold, M.D., professor, Montreal Neurological Institute, McGill University. “Results from the second year of ADVANCE also confirm the positive safety and tolerability profiles of PLEGRIDY seen in year one, which is very encouraging.”
The subcutaneous injectable therapy was approved by the U.S. Food and Drug Administration (FDA) last August, after being granted marketing authorization by the European Commission less than a month before.