What was the trial design for the Phase III EXPAND clinical trial?1,2
EXPAND was a randomized, double-blind, placebo-controlled study in 1651 patients with SPMS. The inclusion criteria were: documented evidence of progression in the 2 years prior to enrollment, no evidence of relapse in the 3 months prior to study enrollment, and an EDSS score of 3.0-6.5 at study entry. Patients were randomized 2:1 to receive either once-daily MAYZENT 2 mg or placebo. Evaluations were performed at screening, every 3 months, and when relapses occurred. MRI evaluations were performed at screening and every 12 months. The follow-up duration was 37 months.
The primary end point of the study was the time to 3-month CDP, defined as a ≥1-point increase from baseline in EDSS score (0.5-point increase for patients with a baseline EDSS score of ≥5.5) sustained for 3 months. A prespecified hierarchical analysis consisted of the primary end point and 2 secondary end points, the time to 3-month confirmed worsening by ≥20% from baseline on the T25-FW test, and the change from baseline in T2 lesion volume. Additional end points included ARR (relapses/year) and MRI measures of inflammatory disease activity.
What is the mechanism of action?1
MAYZENT is a sphingosine 1-phosphate receptor modulator, and it binds with high affinity to S1P receptors 1 and 5.
What is the Expanded Disability Status Scale (EDSS)?3,4
EDSS is a measurement tool that is used to evaluate the progression of physical and/or cognitive disability. EDSS scores range from 0-10 points, and include 0.5-point increments, with higher scores indicating more advanced disability.
What is the indication for MAYZENT?1
MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
What are the most common adverse reactions with MAYZENT?1
The safety profile of MAYZENT was demonstrated in a Phase III clinical trial versus placebo. The most common adverse reactions (incidence ≥10%) were headache (15%), hypertension (13%), and transaminase increases (11%).
How can I get my patients started on MAYZENT?
The MAYZENT Start Form initiates the process in order to get your patient started on MAYZENT. You can fax a hard copy of the Start Form or submit online through your CoverMyMeds account on the Specialty Dashboard tab. E-prescriptions sent through your EMR to Homescripts will automatically push the Start Form to your CoverMyMeds account.
SPMS could be active or non-active SPMS.
ARR=annualized relapse rate; CDP=confirmed disability progression; EDSS=Expanded Disability Status Scale; MRI=magnetic resonance imaging; MS=multiple sclerosis; S1P=sphingosine 1-phosphate; SPMS=secondary progressive MS; T25-FW=timed 25-foot walk.
References: 1. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2019. 2. Kappos L, Bar-Or A, Cree BAC, et al; for the EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263-1273 3. Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9:S5-S48. 4. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444-1452.