MS Patients Receiving Dimethyl Fumarate See Better Quality of Life Scores Than Those Receiving Placebo

Treatment with dimethyl fumarate improved or stabilized health-related quality of life scores in patients with relapse-remitting multiple sclerosis compared to placebo.

Health-related quality of life improved or remained stable in patients with relapse-remitting multiple sclerosis treated with dimethyl fumarate, whereas participants receiving placebo experienced a steady decline in their health-related quality of life over a 2-year period, according to the results of a study published in the Feb. 1, 2014 edition of Multiple Sclerosis Journal.

Researchers assessed patient-related quality of life in 1234 participants for the study. The participants received placebo, 240 mg dimethyl fumarate twice daily, or 240 mg dimethyl fumarate 3 times daily over a 2 year span.

“In the DEFINE study population, health-related quality of life improved or remained stable in patients treated with dimethyl fumarate, compared with a steady decline in health-related quality of life in those receiving placebo, with the difference observed as early as week 23 and maintained over the 2-year study, ” the study authors wrote.

In 1 of the 3 health-related quality of life tests researchers examined, scores for physical and mental components of the test increased as the course of treatment progressed. The same test showed a decrease in those same components in patients receiving placebo.

In general, participants receiving dimethyl fumarate tended to see significant improvements on the test’s physical functioning, general health, vitality, social functioning, and role-emotional subscales when compared to placebo.

The second health-related quality of life test showed stable or improved results over time in participants receiving dimethyl fumarate, but still showed declines in the placebo group.

Improvements in dimensions of mobility and in usual activities drove the differences: 60% of participants in the dimethyl fumarate group reported no problems with dimensions of mobility after 2 years, compared to 50% of participants receiving placebo. Meanwhile, 58% and 60% of participants in the 2 dimethyl fumarate groups reported no problems with usual activities, whereas only 52% of participants in the placebo group gave the same report.

The third assessment showed a slight decline in health-related quality of life scores in both treatment and placebo groups compared to baseline. Despite this, scores in the dimethyl fumarate group remained stable or increased, whereas scores in the placebo group continued to decline. In addition, patients in the treatment group tended to report a better overall impression of wellbeing versus the placebo group.

Researchers also investigated treatment impact in participants who experienced a symptom relapse. Although the 354 participants who experienced symptom relapse reported a significant impairment in health-related quality of life compared to participants who did not relapse, the impact was reduced in the treatment groups.

“These analyses in the DEFINE population showed that relapse-remitting multiple sclerosis was associated with significant health-related quality of life impairment at baseline, and that the health-related quality of life patients treated with dimethyl fumarate improved or remained stable during the 2-year study period,” the researchers wrote. “Together with positive clinical efficacy data, and an acceptable safety and tolerability profile, these health-related quality of life benefits further support the use of dimethyl fumarate as a new treatment option for MS.”