New data reinforce efficacy of TECFIDERA® (Dimethyl Fumarate) in MS patients with high disease activity

Posted: 30 April 2014 | | No comments yet

Additional real-world data show tolerability profile consistent with pivotal studies…

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New data reinforce the efficacy of TECFIDERA in a wide range of patients with relapsing-remitting multiple sclerosis (RRMS), as well as support its favorable safety and tolerability profile in the real-world setting. These data were presented by Biogen Idec (NASDAQ: BIIB) at the 66th American Academy of Neurology (AAN) annual meeting in Philadelphia.

A new post-hoc analysis from the Phase 3 studies, DEFINE and CONFIRM, reinforce that TECFIDERA can be effective in RRMS patients with high disease activity. In addition, new data from the Phase 4 MANAGE study show that gastrointestinal (GI) events experienced by patients in the clinical practice setting were mostly mild to moderate and generally manageable, and significantly decreased in prevalence within the first two months of TECFIDERA treatment.

“These new data further reinforce the benefits TECFIDERA’s strong efficacy may bring to a wide range of people with relapsing forms of multiple sclerosis (MS),” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “In addition, as we gain even more real-world experience with the therapy, it is encouraging to see that its tolerability profile remains manageable and that GI symptoms are largely transient.”

Efficacy in Patients with High Disease Activity

A post-hoc analysis of pooled data from the Phase 3 DEFINE and CONFIRM studies evaluated the efficacy of TECFIDERA in RRMS patients with highly active disease. The findings are consistent with the data from the overall intent-to-treat patient populations in DEFINE and CONFIRM, which supported the regulatory submissions for TECFIDERA globally.

Patients with highly active disease were defined as those who experienced two or more relapses in the year prior to entering DEFINE or CONFIRM and had one or more gadolinium-enhancing (Gd+) lesions at baseline (n=136). Higher relapse frequency and the prevalence of more brain lesions are associated with an increased risk of disease progression.

Results show that at two years, TECFIDERA taken twice daily (BID; n=45) significantly reduced annualized relapse rate (ARR) by 60 percent (p=0.0018) and the proportion of patients who relapsed by 63 percent (p=0.0030). There was no significant effect of TECFIDERA on 12-week confirmed disability progression.

“MS has a spectrum of activity, from mild to very severe, and ranges significantly among patients,” said Professor Michael Hutchinson, consultant neurologist, St. Vincent’s University Hospital and Newman clinical research professor, University College Dublin, Ireland. “It is reassuring that TECFIDERA has demonstrated efficacy across a range of patient populations, including in those who have more active disease. This consistent benefit reinforces the importance of TECFIDERA as a powerful therapeutic agent in the MS treatment paradigm.”

MANAGE Tolerability Results

The open-label, single-arm MANAGE study evaluated the incidence and prevalence of GI-related adverse events (AEs) experienced by U.S. patients with relapsing forms of MS who initiated TECFIDERA treatment in a clinical practice setting. The study also assessed the overall effect of symptomatic therapies on patients’ GI symptoms. Patients were prompted twice a day to report GI-related AEs using an eDiary device and two numerical rating scales: the Modified Acute Gastrointestinal Symptom Scale (MAGISS) and the Modified Overall Gastrointestinal Symptom Scale (MOGISS).

Results show that GI events were largely transient, occurred most frequently in the first month of therapy and were mostly reported as mild to moderate in severity. By the 10th week of treatment, less than 10 percent of patients reported GI AEs. The incidence of discontinuation due to GI-related AEs was low (7.3 percent).

Of those who reported GI AEs, most patients (61.2 percent) used symptomatic therapies to manage the effects. By week 10, less than 10 percent of these patients were using symptomatic treatments.

The safety profile of TECFIDERA observed in MANAGE was consistent with that in the pivotal DEFINE and CONFIRM studies, with no new or worsening safety signals.

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