Early Adopters of Tecfidera: Preliminary Characteristics and Patient-Reported Outcomes from the NARCOMS Registry

Background: Oral disease-modifying therapies (DMT) offer a convenient treatment option for people with relapsing remitting multiple sclerosis (RRMS).  Several factors are associated with a decision to start a new treatment, such as anticipated efficacy, potential adverse effects, and cost. Little is known about the real-world patient experience following initiation of recently approved therapies. The April 2013 introduction of Tecfidera (oral dimethyl fumarate, DMF) to the growing number of FDA approved DMTs provided an opportunity to assess the initial experiences of early adopters.

Objectives: To compare groups of DMF users based on their current and past treatment history.

Methods:  Respondents to the NARCOMS Fall 2013 update survey who completed DMT and functionality questions were included. Functionality was assessed using the Patient Determined Disease Steps (PDDS). We conducted nonparametric Wilcoxon Rank and Chi-square tests for comparisons as applicable and used covariate adjusted ANOVA for change in PDDS. A p-value < 0.05 was considered meaningful.   

Results: Of the 8284 responders to the NARCOMS Fall 2013 update survey, 8093 (97.7%) completed the DMT questions: 449 (5.5%) of them reported using DMF in the past 6 months; 366 (81.5%) indicated current use. Of the 52 (11.6%) who stopped using DMF and 31 (6.9%) not indicating a current status, only 6 (7.2%) reported a switch to another DMT. As expected in MS population, DMF users were predominantly female (83.0%) and white or white/mixed (82.4%); 63 (14.0%) were diagnosed within the past five years. The median [range] age of all users was 53.4 [25.5, 79.8] and disease duration 14 [2,45] years, both slightly lower than in the registry overall; with 98.8% reporting having health insurance. At enrollment, participants reported a median [range] PDDS of 3[0,7] “Gait Disability”; with an increase in PDDS of 1[-5,7] points at update survey, adjusted for starting PDDS, age at survey and time of follow up (no difference by status of DMF use).

Conclusions:  Since FDA approval, 5.5% of NARCOMS survey responders reported taking DMF, with a higher adoption rate observed in the younger segment of the registry population. Current and past users had similar demographics and disability level. No significant differences in disability progression emerged between the groups, potentially due to the brief post-change follow-up period. Reasons for DMF usage, as well as disability and medication history, will be reported.

Acknowledgements: NARCOMS is supported in part by the CMSC and the Foundation of the CMSC.  This study was supported by Biogen-Idec.