PracticeUpdate Conference Series - ANZAN 2018

Natalizumab Reduces Disease Activity More Than and Faster Than Fingolimod in Patients With Active RRMS

Natalizumab has been found to reduce disease activity more than, and to a greater extent than fingolimod in patients with active relapsing-remitting multiple sclerosis (RRMS), reports the randomized head-to-head REVEAL trial. Other research presented on natalizumab included the outcomes of patients who remained on the drug vs those who switched off it, measures to reduce adverse events, and experience with home infusion. H elmut Butzkueven, MD, of Monash University in Box Hill, Victoria, explained that REVEAL was designed as a 1-year, multicenter, rand- (cumulative gadolinium-enhancing lesions over time).

As expected for a randomized study, patient characteristics and follow-up duration (median 39 weeks) were similar between groups. Natalizumab patients were less likely than those taking fingolimod to develop new gadolinium- enhancing lesions (for at least one lesion, cumulative probability 40.68% vs 57.99%; hazard ratio [HR] 1.678 [95% CI 0.865–3.255]; P = .1258; for at least two lesions, cumulative probability 11.54% vs 48.48%; HR 4.053 [95% CI 1.474–11.144]; P = .007). Consistently, natalizumab patients exhibited 63–72% fewer gadolinium-enhancing lesions than fingolimod patients, with between-group dif- ferences apparent within 4 weeks and reaching significance by 12 weeks (P = .030). The annualized relapse rate was 83% lower with natalizumab than with fingolimod (0.05 vs 0.29; P = .023). The cumulative probability of relapse was 1.85% with natalizumab vs 22.28% with fingolimod

omized, rater- and sponsor-blinded, prospective comparison of natalizumab vs fingolimod in patients with active RRMS. Though the study closed early for reasons unre- lated to safety or efficacy, the data permitted comparison of effects that occurred soon after treatment initiation. The analysis compared onset of efficacy with natalizumab vs fingolimod. Patients were randomized to open-label intrave- nous natalizumab 300 mg every 4 weeks (n=54) or oral fingolimod 0.5 mg once daily (n=54). MRI was scheduled every 4 weeks for the first 24 weeks and at weeks 36 and 52. Analyses included Kaplan-Meier and Cox regression, negative binomial regression (annualized relapse rate), the number of T1 gadolinium-enhancing lesions, and a negative binomial generalized estimating equation

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PRACTICEUPDATE CONFERENCE SERIES • ANZAN 2018