title: Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse.
abstract: OBJECTIVE
  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.
authors: Department of Neurology, Northwestern University, 710 North Lake Shore Drive, Abbott Hall 1121, Chicago, IL 60611, USA. Electronic address: bac106@northwestern.edu.
authors: B A
authors: BA
authors: Cohen
authors: Department of Neurology, Stony Brook University, Health Sciences Center, T12-020, Stony Brook, NY 11794, USA. Electronic address: Patricia.Coyle@stonybrookmedicine.edu.
authors: P K
authors: PK
authors: Coyle
authors: Comprehensive MS Center, Thomas Jefferson University, 900 Walnut St. #200, Philadelphia, PA 19107, USA. Electronic address: thomas.leist@jefferson.edu.
authors: T
authors: T
authors: Leist
authors: Health Outcomes Research Consulting and Writing, Outcomes Scribe, LLC, 664 Wynding Oaks, Kalamazoo, MI 49006, USA. Electronic address: OutcomesScribe@gmail.com.
authors: M A
authors: MA
authors: Oleen-Burkey
authors: Biostatistics, MedNet Solutions, Inc., 110 Cheshire Lane, Ste. 300, Minnetonka, MN 55305, USA. Electronic address: mschwartz@mednetstudy.com.
authors: M
authors: M
authors: Schwartz
authors: Neuroscience Consultants, Comprehensive Multiple Sclerosis Center, 4601 Ponce de Leon Blvd, Ste. 100, Coral Gables, FL 33146, USA. Electronic address: zwibelmdms@aol.com.
authors: H
authors: H
authors: Zwibel
mesh_terms: D000328:Adult; D015331:Cohort Studies; D005260:Female; D000068717:Glatiramer Acetate / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016899:Interferon-beta / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000523:psychology*; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance; D012008:Recurrence
chemical_list: D007155:Immunologic Factors; D000068717:Glatiramer Acetate; D016899:Interferon-beta
keywords: Adherence; Compliance; Disability; Disease-modifying therapy; Multiple Sclerosis; Relapse