Siponimod continues to look promising for multiple sclerosis. Researchers report good results on three-year extension of BOLD study.
Patients with relapsing-remitting multiple sclerosis (RRMS) receiving siponimod treatment for 24 months had low disease activity and showed no new safety signals, according to an extension of the phase 2 BAF312 on MRI Lesion Given Once Daily (BOLD) study. The extension was conducted by Ludwig Kappos, MD, of the Neurologic Clinic and Proclinic, in the Department of Medicine at the University Hospital Basel in Switzerland, and colleagues, and was published in JAMA Neurology in July, 2016.
This study extension was dose-blinded and randomized, and the main outcomes included a safety assessment and efficacy measures. The researchers say, “Safety assessment included blood tests, documentation of adverse events at regular scheduled visits and Holter monitoring; key efficacy measures were annualized relapse rate and magnetic resonance imaging lesion activity.”
The extension ran from August 30, 2010 until June 3, 2013. “All patients who completed the BOLD Study were eligible to enter the extension,” say the authors, and 184 (73%) chose to do so. Of those, 159 completed the extension.
The annualized relapse rate (ARR) remained low for all patients receiving siponimod doses through month 24 of the extension. Additionally, the researchers report, “There was no treatment-related change in Expanded Disability Status Scale score during the dose-blinded extension phase.”
The most common adverse events (AEs) were, the researchers say, “nasopharyngitis, headache, lymphopenia, upper respiratory tract infections, increased aminotransferase, pharyngitis, and insomnia.” However, they also note, “the overall incidence of AEs ranged between 84.0% and 96.6% across treatment groups during the dose-blinded extension phase.” Serious AEs were less common with only 9 patients reporting serious AEs.
The researchers conclude, “Notwithstanding some limitations, post hoc analyses of this dose-blinded study indicate that siponimod has a sustained effect on MRI outcomes at both the 2-mg and 10-mg doses.” They continue, “Siponimod, 2 mg, has been chosen for further development as a treatment for patients with MS and is currently being investigated in a phase 3 study in patients with secondary progressive MS.”