â€œIn the clinical studies, daclizumab demonstrated statistically significant benefits on clinical, radiographic, and patient-reported outcome measures in patients with RRMS.â€
Daclizumab can be used for at least 6.5 years safely to treat patients with relapsing-remitting multiple sclerosis (RRMS), according to a recent integrated analysis. The analysis was performed by Gavin Giovanonni, PhD, of the London School of Medicine and Dentistry, and was published in the journal Multiple Sclerosis and Related Disorders.
The researchers began with the objective to “Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies,” they said. They wanted to examine adverse events across all the studies, in which patients received at least one dose per month of subcutaneous daclizumab of either 150 mg or 300 mg.
There were 2236 patients in total, and the researchers say they had “5214 patient-years of exposure to daclizumab.” The overall cumulative incidence of adverse events was high at 84%, but most were mild to moderate; only 12% of the patients experienced a severe adverse reaction. Additionally, the researchers say, “The incidence of any AE [adverse event] when evaluated by 6-month intervals in all daclizumab-exposed patients remained stable over time.”
The six clinical trials provide enough information about the safety of daclizumab to sufficiently identify “risks associated with daclizumab therapy, including uncommon risks and risks associated with incidence as low as 1 per 1000 patient-years; however it is not large enough to identify rare events,” say the researchers. The adverse events of most concern are hepatic and serum transaminase elevations. Although most were self-limiting and patients recovered, there was one incident of autoimmune hepatitis which resulted in death.
The researchers conclude that this integrated analysis shows daclizumab is well-tolerated for up to 6.5 years, and most adverse events are mild to moderate. They add, “In the clinical studies, daclizumab demonstrated statistically significant benefits on clinical, radiographic, and patient-reported outcome measures in patients with RRMS.”