Abstract: Characterizing Early Real-World Experience of Narcoms Registry Participants Treated with Diroximel Fumarate (2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DMT10
Characterizing Early Real-World Experience of Narcoms Registry Participants Treated with Diroximel Fumarate

Thursday, June 2, 2022

Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)

Amber Salter, PhD , Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX

Samantha Lancia, MS , Department of Biostatistics, UT Southwestern Medical Center, Dallas, TX

Ruth Ann Marrie, MD, PhD , Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada

Gary R Cutter, PhD , Biostatistics, University of Alabama at Birmingham, Birmingham, AL

Robert J Fox, MD , Mellen Center for Treatment and Research in Multiple Sclerosis, Cleveland Clinic, Cleveland, OH

Sarah M England, PhD , Biogen, Cambridge, MA

Shivani Kapadia, PharmD, RPh , Biogen, Cambridge, MA

Sai L Shankar, PhD , Biogen, Cambridge, MA

James B Lewin, PharmD , Biogen, Cambridge, MA

PDF

Background: Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of MS. In clinical trials, DRF demonstrated improved gastrointestinal (GI) tolerability compared to dimethyl fumarate (DMF). Real-world experiences related to how individuals take DRF (e.g., with or without food and titration schedule) are lacking. Persistence to DRF in the real-world setting, and whether it is affected by GI tolerability are also unknown.

Objectives: To investigate dietary practices and titration regimens in participants with MS initiating DRF and to examine overall and GI-related discontinuation rates.

Methods: We included participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry reporting DRF initiation between April 2020 and May 2021, with at least 1 follow-up survey ≥6 months after DRF initiation, living in the US, diagnosed with relapsing MS, and who had not discontinued DRF for solely financial reasons. The semi-annual surveys included questions on the dietary practices and initial dosing regimen for participants who initiated DRF. Data were summarized using descriptive statistics.

Results: Overall, 55 NARCOMS participants initiated DRF, of whom 39 met the inclusion criteria. The participants had a mean (SD) age of 57.5 (10.0) years and BMI of 27.7 (7.2), were mostly female (94.9%) and white (89.7%). Average (SD) disease duration was 19.8 (9.40) years, age at MS diagnosis was 36.6 (10.6) years, and 48.7% had none-to-mild disability (Patient-Determined Disease Steps score ≤1). DMF was the most frequent prior DMT (74.4%). The initial DRF dosing regimen for most participants was the full dose immediately (25.6%), or 1-week titration (43.6%). The morning dose was often taken with a full meal (29.4%) or a small snack (38.2%), while 14.7% took the morning dose without food or whenever convenient (17.6%). Evening doses were reported to be taken without food (38.5%), with a full meal (25.6%) and whenever convenient (23.1%). Six participants (15%) discontinued DRF (5 due to non-GI adverse effects; 1 due to progressive MS). No participants reported discontinuing DRF due to GI adverse effects.

Conclusions: Early DRF initiators in NARCOMS showed heterogeneity with respect to dietary practices for DRF dose regimens and short titration schedules. No discontinuations due to GI side effects were observed. The effects of DRF on disability progression and patient-reported outcomes will be followed longitudinally.

Support: Biogen. NARCOMS is a project of the CMSC

DMT10 Characterizing Early Real-World Experience of Narcoms Registry Participants Treated with Diroximel Fumarate

DMT10
Characterizing Early Real-World Experience of Narcoms Registry Participants Treated with Diroximel Fumarate