Abstract
ObjectiveSELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED.MethodsEligible participants who completed 1–2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION.ResultsNinety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0–24 was 0.21 (0.16–0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.ConclusionsThe effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED.Trial registrationClinicaltrials.gov NCT01051349; first registered on January 15, 2010.
Highlights
Relapsing–remitting multiple sclerosis (RRMS) is a neurodegenerative demyelinating disease characterized by acute relapses of neurologic symptoms and progressive accumulation of irreversible disability [4]
Daclizumab beta was approved in the United States, Europe, Canada, and other countries for the treatment of relapsing forms of MS based on evidence from pivotal clinical trials that showed superior efficacy vs placebo and intramuscular interferon beta-1a on key clinical and radiologic disease outcomes [2, 15, 21] and a favorable risk–benefit profile at the time of marketing authorization (May and July 2016 in the United States and Europe, respectively) [9]
The SELECT/SELECTION/SELECTED clinical trials investigated the safety and efficacy of daclizumab beta in more than 400 participants with RRMS. These final findings from the SELECTED extension study indicate that adverse events (AEs) continued to occur over the extended treatment period, the yearly incidence and severity of AEs remained stable throughout the daclizumab beta treatment period and did not increase with long-term exposure
Summary
Relapsing–remitting multiple sclerosis (RRMS) is a neurodegenerative demyelinating disease characterized by acute relapses of neurologic symptoms and progressive accumulation of irreversible disability [4]. Blockade of CD25 by daclizumab beta prevents formation of the high-affinity IL-2 receptor and shifts IL-2 signaling to the intermediate-affinity receptor [2, 24]. Daclizumab beta was approved in the United States, Europe, Canada, and other countries for the treatment of relapsing forms of MS based on evidence from pivotal clinical trials that showed superior efficacy vs placebo and intramuscular interferon beta-1a on key clinical and radiologic disease outcomes [2, 15, 21] and a favorable risk–benefit profile at the time of marketing authorization (May and July 2016 in the United States and Europe, respectively) [9]. Daclizumab beta was formulated to be selfadministered subcutaneously (SC) once monthly [2]
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