PND16 - Safety Profile of Daclizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis

Abstract

Daclizumab is a humanised monoclonal antibody and is considered to be efficaious for the treatment of relapsing-remitting multiple sclerosis (RRMS). We conducted a meta-analysis to assess the safety of daclizumab for the treatment of RRMS. We searched PubMed, Cochrane library and Clinicaltrials.gov databases from inception for identification of relevant randomised controlled trials (RCTs) comparing daclizumab with placebo for the treatment of RRMS. The main outcome was safety in terms of various adverse events at 52 weeks. Four authors independently screened titles, abstracts and subsequently the full texts of all the potentially relevant studies. The same four authors extracted data and assessed risk of bias using the modified Jadad scale. Total of four RCTs involving 3286 RRMS patients were included in this meta-analysis. RRMS patients received 150mg or 300mg daclizumab via subcutaneous route. The pooled results indicated no significant difference between daclizumab and placebo for any adverse event (Risk Ratio [RR] 0.98, 95% CI 0.92 to 1.03; three RCTs). However, upon individual analyses based on specific adverse events, significant association was found for infections (RR 1.16, 95% CI 1.04 to 1.30; three RCTs) and cutaneous events (RR 1.93, 95% CI 1.68 to 2.22; three RCTs) when compared to placebo. There were no significant associations found for upper respiratory tract infections (RR 1.38, 95% CI 0.97 to 1.97; three RCTs), rash (RR 1.73, 95% CI 0.90 to 3.30; two RCTs), headache (RR 0.92, 95% CI 0.68 to 1.25; three RCTs), and nasopharyngitis (RR 1.02, 95% CI 0.75 to 1.38). Overall, the risk of bias of included trials was low. Our findings demonstrated that incidence of any adverse event with daclizumab was comparable with placebo however; it was associated with more infections and cutaneous events during the treatment of RRMS. Furthermore, high quality trials are needed to establish the safety of daclizumab.