Adherence and discontinuation rates in patients on Tecfidera™ (dimethyl fumarate): Long-term Canadian experience from the Biogen ONE™ support program

• Published in: Multiple sclerosis and related disorders 2022-11, Vol.67, p.104080-104080, Article 104080
• Main Authors: Thompson, Mattea Tan, Virginia, Devonshire, Nick, Belviso, Melissa, Gillen, Engineer, Noella, Shen, Changyu, Reedie, Scott
• Format: Article
• Language: English
• Subjects: Adherence; Disease-modifying therapy; Multiple sclerosis; Patient-support program; Real-world evidence
• ISSN: 2211-0348; 2211-0356
• DOI: 10.1016/j.msard.2022.104080

•Dimethyl fumarate (DMF) is a disease-modifying therapy for multiple sclerosis (MS).•90.4% of patients (N = 6848) were adherent to DMF in this Canadian support program.•Persistence on DMF treatment was 57.0% at 24 months.•Mean decrease in absolute lymphocyte count was 29.2% in the first year of treatment.•As the program continued (2013–2021), DMF was initiated earlier in the course of MS. Tecfidera™ (dimethyl fumarate [DMF]; Biogen) is an oral disease-modifying therapy (DMT) indicated in Canada for the treatment of relapsing-remitting multiple sclerosis (MS). Biogen ONE™, an ongoing Canadian support program, facilitates access to DMF for patients with MS and maintains a database for the purposes of service provision. These data were utilized to assess adherence, persistence, discontinuations, and other outcomes between 2013 and 2021. This non-interventional, retrospective study examined real-world use of DMF prescribed to patients with MS in Canada who were enrolled in the program and received their first dose between April 1, 2013, and June 30, 2021. Follow-up visits and laboratory monitoring occurred based on local standards and per the Canadian product monograph. For adherence and persistence assessments, patients must have had DMF dispensed by specialty pharmacies. Data were collected at patient enrollment, program exit, and throughout the duration of the program. The primary objective was to assess treatment adherence rates to DMF. Secondary objectives included treatment persistence rates, reasons for discontinuation, absolute lymphocyte counts (ALCs), and patient characteristics throughout the duration of the program. Overall, 12,608 DMF patients from the program were included between April 1, 2013, and June 30, 2021. At enrollment, mean (standard deviation [SD]) age was 40.6 (10.7) years and mean (SD) Expanded Disability Status Scale (EDSS) score was 2.2 (1.4). DMF was initiated as first-line DMT in 48.8% of patients. Of patients assessed (n = 6,848), 90.4% were adherent to DMF (based on medication possession ratio [MPR] ≥ 80%). Adherence (mean MPR) was marginally greater in DMT-naïve than switch patients, and in younger (< 40 years) than older (≥ 40 years) patients (both p