The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform

Vilija G Jokubaitis,Mark Slee,On Behalf Of The Australian Msbase Study Group ,Jeannette Lechner-Scott,Danny Liew,Tim Spelman,Cameron Shaw,Helmut Butzkueven,Michael Barnett,Steve Vucic,Celia Oreja-Guevara

doi:10.1371/journal.pone.0059694

Abstract

ObjectiveTo prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS) population.MethodsTertiary MS treatment centres participating in the MSBase registry prospectively assessed treatment utilisation, persistence, predictors of treatment discontinuation and switch rates. Multivariable survival analyses were used to compare treatment persistence between drugs and to identify predictors of treatment discontinuation.Results1113 RRMS patients were studied. Patients persisted on their first disease-modifying therapy (DMT) for a median of 2.5 years. Treatment persistence on GA was shorter than on all IFNβ products (p<0.03). Younger age at treatment initiation and higher EDSS were predictive of DMT discontinuation. Patients persisted on subsequent DMTs, for 2.3 years. Patients receiving natalizumab (NAT) as a subsequent DMT persisted longer on treatment than those on IFNβ or GA (p<0.000). The primary reason for treatment discontinuation for any drug class was poor tolerability. Annualised switch or cessation rates were 9.5–12.5% for individual IFNβ products, 11.6% for GA and 4.4% for NAT.ConclusionThis multicentre MS cohort study is the first to directly compare treatment persistence on IFNβ and GA to NAT. We report that treatment persistence in our Australian RRMS population is short, although patients receiving IFNβ as a first DMT persisted longer on treatment than those on GA. Additionally, patients receiving NAT as a subsequent DMT were more likely to persist on treatment than those switched to IFNβ or GA. EDSS and age at DMT initiation were predictive of DMT discontinuation. Treatment intolerance was the principal reason for treatment cessation.

Highlights

Multiple Sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system
The cohort consisted of patients with clinically isolated syndrome (CIS) 6.0%, relapses and remissions (RRMS) 68.8%, secondary progressive MS (SPMS) 15.8%, primary progressive MS (PPMS) 6.6% and progressive relapsing MS (PRMS) 2.8%
Concordant with this report, in our study we show that 65% of eligible patients in our registry were treated at the time of data extraction and that in the most recent two-year observation period, our patients prescribed disease modifying therapies (DMT) spent 87% of this time on treatment

Summary

Introduction

Multiple Sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system. For most patients with MS, the initial disease course features relapses and remissions (RRMS), whereas the later disease course is characterised by the progressive accumulation of disability. In the course of RRMS, parenteral disease modifying therapies (DMT), such as interferon-beta (IFNb), glatiramer acetate (GA) or natalizumab (NAT) reduce the relapse rate and the rate of disability progression [1,2,3,4]. The concept of treatment adherence encompasses both compliance and persistence. Compliance can be defined as the ability to follow a pre-specified administration schedule without missing doses, which was not assessed in the current study. Persistence refers to a patient’s ongoing treatment utilisation [5]

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Discussion

Conclusion