@article{de14fb48b0e342b597148e3ca83c0c31,
title = "Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse",
abstract = "Objectives The objective of the Therapy Optimization in MS (TOP MS) Study was to prospectively assess the relationship between MS disease-modifying therapy (DMT) adherence and MS relapse risk over 2 years. Methods Potential participants were recruited for TOP MS by specialty pharmacies who dispensed glatiramer acetate and beta interferons for MS nationwide. Signed IRB-approved informed consents were returned to the pharmacies. TOP MS used electronic data capture with monthly patient entries. Adherence, measured by medication possession ratio (MPR), was derived from pharmacy shipment records. Logistic regression examined the association between protocol-defined relapses and DMT MPR (<0.5; >0.5-<0.9; >0.9). Results TOP MS enrolled 3151 persons with MS, and 2410 completed the full 2 years. Across all therapies, the mean MPR for the 2-year completer cohort of 2049 who maintained the same DMT was 0.9+0.2 (range: 0.1-1.0), with 63.8% reaching a 2-year MPR >0.9. Evaluated by categories of MPR, the proportion of participants remaining relapse-free for 24 months increased with increasing MPR, and the proportion with >1 relapses declined with increasing levels of MPR (p<0.0008). Regression analysis revealed the odds of relapse for a patient in the MPR >0.9 MPR group was 64% that of a patient in the MPR <0.5 category (p=0.02). Use of >1 DMT prior to the current one was an independent predictor of relapse. Conclusions The study provides class III evidence that improvement in adherence to DMT for MS is associated with improved clinical outcomes as measured by relapse reduction.",
keywords = "Adherence, Compliance, Disability, Disease-modifying therapy, Multiple Sclerosis, Relapse",
author = "Cohen, {B. A.} and Coyle, {P. K.} and T. Leist and Oleen-Burkey, {M. A.} and M. Schwartz and H. Zwibel",
note = "Funding Information: This study was funded by Teva Pharmaceuticals. Funding Information: Dr. Cohen has received consulting compensation from Acorda, Astellas, Biogen-Idec, EMD-Serono, Genzyme, Sanofi-Aventis, and Teva Neuroscience. Dr. Cohen has also received research support through Northwestern University from NIH, Biogen-Idec, EMD Serono, Novartis, and Hoffman La Roche and funding support through Northwestern University for a CME course from Teva Neuroscience. Funding Information: Dr. Coyle has received personal compensation for consulting and development of educational material from Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi Aventis, Merck Serono, Mylan, Novartis, and Teva. Dr. Coyle has also received research support from clinical trials sponsored by Actelion, Novartis and Opexa. Funding Information: The authors wish to acknowledge the contributions of MedNet Solutions personnel who designed the study database and website interface, hosted the website, managed the data collection, provided technical assistance to study managers and participants, and performed the data analyses. We also acknowledge the study managers at the specialty pharmacies: Cora Edwards, CCRP, Diplomat Specialty Pharmacy, Kira Botkin, BioScrip, Inc., Christina Makowski and Dann Yelen, Walgreens Specialty Pharmacy, who recruited and enrolled study participants, collected data, and managed the study operations at their respective sites. The contributions of Iris Culbert, MSHS, who managed the study for Teva Pharmaceuticals and Dr. Mary D. Hughes, University Medical Group Neuroscience Associates, Greenville, SC; Dr. Clyde E. Markowitz, University of Pennsylvania, Philadelphia, PA, and Dr. Mark Tullman, Missouri Baptist Medical Center, St. Louis, MO, who participated on the TOP MS Steering Committee during the design and implementation phases of the study are acknowledged. The study was funded by Teva Pharmaceuticals , USA, Inc. Publisher Copyright: {\textcopyright}2014 Elsevier B.V. All rights reserved. Copyright: Copyright 2016 Elsevier B.V., All rights reserved.",
year = "2015",
month = jan,
day = "1",
doi = "10.1016/j.msard.2014.09.214",
language = "English (US)",
volume = "4",
pages = "75--82",
journal = "Multiple Sclerosis and Related Disorders",
issn = "2211-0348",
publisher = "Elsevier",
number = "1",
}