New daclizumabdata have demonstrated positive cognitive outcomes for daclizumab, targeted and reversible mechanism of action (MOA), and safety profile in patients with relapsing-remitting multiple sclero
Presented at the 68th Annual Meeting of the American Academy of Neurology (AAN) in Vancouver, Canada, the research is from Biogen’s DECIDE study.
Sustained cognitive outcomes achieved with daclizumab
Data presented from the phase 3 DECIDE study highlight a positive, sustained impact that daclizumab may have on cognitive function for patients with RRMS, in particular processing speed and attention.
In the multi-centre, double-blind, active-controlled, phase 3 study of 1,841 patients, cognitive improvements were measured using the Symbol Digit Modalities Test (SDMT – a measure of information-processing speed and attention), across a daclizumab group and an intramuscular (IM) interferon beta-1a group. Improvements in SDMT ≥3 points or ≥4 points are deemed to be clinically meaningful.
Clinically meaningful improvements in SDMT scores (≥3 points, ≥4 points) were observed in a higher percentage of patients receiving daclizumab vs. interferon beta-1a IM at week 96 (60% vs 51.4% respectively for ≥3 point improvement (P=.0153), and 55.4% vs 50.1% respectively for ≥4 points (P=.0366)). These improvements were sustained at week 144 (65.5% vs 52.0% respectively for ≥3 point improvement (p=.0028), and 61.7% vs 48.4% respectively for ≥4 points (p=.0067)). Mean improvements from baseline at week 144 as measured using the SDMT were +6.30 for daclizumab-treated patients vs +3.09 for interferon beta-1a IM-treated patients (p=0.0024).
Daclizumab-targeted MOA supports safety profile
Daclizumab selectively modulates interleukin-2 receptor signalling, leading to selective antagonism of pro-inflammatory effector T-cell activity and increased numbers of immune-regulatory CD56 natural killer (NK) cells. Data presented from the SELECT and SELECTION studies demonstrated that decreases in total, and differential, lymphocyte counts during treatment were modest and reversible upon treatment discontinuation. The CD4+/CD8+ ratio remained stable in SELECT and SELECTION. The absence of profound depletion of total lymphocytes, CD4+ and CD8+ T cells, and CD56 NK cells during treatment, and the reversibility of the changes in cell counts, provide further evidence of the targeted immunomodulatory MOA of daclizumab in RRMS.
Additional data presented from the DECIDE study assessed cutaneous adverse events associated with daclizumab. The majority (94%) of adverse events observed were mild or moderate. The rate of serious adverse events remained low at 2%, which were resolved following topical and/or systemic steroids, antihistamines, other therapies or treatment discontinuation. These data highlight that although serious adverse events were infrequent, physicians should be aware that these events can occur and may need to be managed with multiple therapies.