Pauline Anderson

June 02, 2013

ORLANDO, Florida — A post hoc analysis of phase 3 studies in patients with relapsing-remitting multiple sclerosis (RRMS) clearly showed that those taking the oral agent BG-12 (dimethyl fumarate; Tecfidera, Biogen Idec Inc.) experienced significant improvements in physical and mental functioning, general well-being, and overall health status, whereas those receiving placebo typically reported declines in these measures of quality of life.

"After treatment with BG 12, both the 3-times-a-day and twice-a-day dosing, at the first measurement point at 6 months, we're seeing either an improvement in quality of life or at least no change, whereas the placebo group is showing a consistent decrease in quality of life over this same period of time," said Mariko Kita, MD, Virginia Mason Medical Center, Seattle, Washington, who presented the research.

The results, using data from the pivotal DEFINE and CONFIRM trials, were presented here at the 5th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

Measures of Well-being

Approved by the US Food and Drug Administration as a first-line oral treatment for MS earlier this year, BG12 is thought to act as an immunomodulating agent, inhibiting proinflammatory cytokines and chemokines and promoting anti-inflammatory activity. It also acts as an antioxidant and may also have a neuroprotective effect.

The current analysis included patients receiving placebo (n = 733), BG-12 twice daily (n = 741), and BG-12 3 times a day (n = 728). Patients completed the Short Form 36 health survey (SF-36) at 6, 12, and 24 months. Their global impression of well-being was assessed every 3 months using a visual analogue scale. Patients also completed the European Quality of Life–5 Dimensions health survey at 6, 12, and 24 months.

Patients taking BG-12 reported significant increases in mean physical component summary (PCS) and mental component summary (MCS) scores on the SF-36 at 2 years, whereas those receiving placebo had a decrease in these mean scores.

The proportion of patients who achieved a clinically relevant 5-point improvement in PCS and MCS scores was significantly higher for those taking BT-12. For example, for PCS, the odds ratio (OR) of BG-12 3 times a day compared with placebo was 1.48 (95% confidence interval [CI], 1.21 - 1.81; P = .0001). For MCS, the OR for that same group vs placebo was 1.63 (95% CI, 1.33 - 2.00; P < .0001).

Patients receiving the drug also did better in terms of well-being. The mean change on the Global Impression of Well-being (VAS) score in the placebo group was -4.0 compared with -0.3 and 0.1 in the BG-12 twice-daily and 3-times-daily groups, respectively (both P < .0001)

The physical, mental, and emotional measurements captured things such as depression, fatigue, cognitive problems, how well patients thought their pain was being controlled, and how disabled they felt.

Dr. Mariko Kita

Such information might influence choice of drugs and even reassure patients who are fearful of side effects, said Dr. Kita. "You would be surprised at the number of patients out there who opt to avoid treatment, and this is an important reminder that being on these treatments can have more benefit than meets the eye."

That is not to say that this drug is without side effects. When patients start taking this drug, they may experience nausea, diarrhea, vomiting, or flushing, said Dr. Kita. There can also be issues with a drop in lymphocyte count or even some liver dysfunction.

The DEFINE and CONFIRM trials had demonstrated an acceptable safety profile as well as significant clinical and magnetic resonance imaging efficacy in RRMS patients.

The DEFINE and CONFIRM trials were funded by Biogen Idec Inc. Dr. Kita reports that she has received research support from Biogen Idec Inc.

5th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).Poster SX18. Presented May 30, 2013.

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