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Multicenter Study
. 2013;8(3):e59694.
doi: 10.1371/journal.pone.0059694. Epub 2013 Mar 19.

The Australian Multiple Sclerosis (MS) immunotherapy study: a prospective, multicentre study of drug utilisation using the MSBase platform

Vilija G Jokubaitis  1 , Tim Spelman, Jeannette Lechner-Scott, Michael Barnett, Cameron Shaw, Steve Vucic, Danny Liew, Helmut Butzkueven, Mark Slee; Australian Msbase Study Group
Collaborators, Affiliations
Multicenter Study

The Australian Multiple Sclerosis (MS) immunotherapy study: a prospective, multicentre study of drug utilisation using the MSBase platform

Vilija G Jokubaitis et al. PLoS One. 2013.

Abstract

Objective: To prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS) population.

Methods: Tertiary 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.

Results: 1113 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.

Conclusion: This 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.

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Conflict of interest statement

Competing Interests: Dr Jokubaitis reports no disclosures. Dr Spelman has received a travel grant from Novartis Australia. Dr Lechner-Scott’s institution receives non-directed funding as well as honoraria for presentations and membership on advisory boards from CSL, Genzyme, Biogen Idec, Bayer Health Care, Merck Serono and Novartis Australia. Dr Barnett has received research support and/or honoraria from Bayer Schering, Biogen Idec, Merck Serono, Novartis Pharma, Sanofi and Teva. Dr Shaw reports no disclosures. Dr Vucic serves on the scientific advisory board from Novartis Pharma, Merck Serono Australia and Bayer Schering Australia. Dr Vucic serves as a medical consultant for Merck Serono Australia. Dr Liew has received honoraria from Novartis and Sanofi. Dr Butzkueven has served on scientific advisory boards for Biogen Idec, Novartis and Sanofi and has received conference travel support from Novartis, Biogen Idec and Sanofi. He serves on steering committees for trials conducted by Merck Serono, Biogen Idec and Novartis. Dr Butzkueven has received research support from Merck Serono, Novartis and Biogen Idec in his capacity as honorary chair of the MSBase Foundation. He is on the editorial board of Multiple Sclerosis International. Dr Slee reports participating in advisory boards for Sanofi, Merck Serono, Biogen Idec, Novartis Pharma and Bayer Schering. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Kaplan-Meier survival estimates for treatment discontinuation (First DMT).
A: Treatment discontinuation by DMT. This figure demonstrates that patients prescribed Glatiramer Acetate as a first DMT discontinue treatment at a significantly greater rate than those prescribed any of the IFNβ preparations (adjusted Cox Proportional Hazards Regression, p<0.03). B: Treatment discontinuation by EDSS. This figure demonstrates that patients with an EDSS of 3–5.5 discontinue the use of a first DMT at a greater rate than those with an EDSS of 0 (adjusted Cox Proportional Hazards Regression, p = 0.08).
Figure 2
Figure 2. Kaplan-Meier survival estimates for treatment discontinuation (Subsequent DMT).
A: Treatment discontinuation by DMT. This figure demonstrates that patients prescribed Natalizumab as a subsequent DMT discontinue treatment at a significantly slower rate than those prescribed Glatiramer Acetate or any of the IFNβ preparations (adjusted Cox Proportional Hazards Regression, p = 0.000). B: Treatment discontinuation by EDSS. This figure demonstrates that patients with EDSS 1–2.5 (p = 0.046), EDSS 3–5.5 (p = 0.013) and EDSS ≥6 (p = 0.008) discontinue treatment at a significantly greater rate than those with EDSS 0 (adjusted Cox Proportional Hazards Regression).
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